1.  Peer Reviewed Title: Bleeding pattern, tolerance and patient satisfaction with a drospirenone-containing oral contraceptive evaluated in 3488 women in Europe, the Middle East and Canada. Author: Endrikat JS; Milchev NP; Kapamadzija A; Georgievska J; Gerlinger C; Schmidt W; Feroze S Source: Contraception. 2009 Jun;79(6):428-32. Abstract: BACKGROUND: This study was conducted to assess the bleeding pattern, tolerance and patient satisfaction associated with an oral contraceptive (OC) containing 3 mg of drospirenone and 30 mcg of ethinyl estradiol under real-life conditions. STUDY DESIGN: A multicenter, prospective and observational six-cycle study was conducted in 12 countries in Europe, the Middle East and Canada. The efficacy variables included an assessment of bleeding patterns, premenstrual symptoms of water retention and patient satisfaction as determined by a visual analog scale. RESULTS: A total of 3488 women was enrolled in the study. The percentage of women with intermenstrual bleeding decreased from 27.9% at baseline to 5.4% at the end of Cycle 6, while dysmenorrhea decreased from 67% to 17.7%. Also, amenorrhea decreased from 21.3% to 7.5%. The decreases in all three parameters were statistically significant (p<.0001). Approximately 70% of the women reported abdominal bloating and/or breast tenderness at baseline and less than 38% did so at the end of Cycle 6 (p<.0001). Patient satisfaction increased for all investigated items. Upon completion of the study, 86.2% of the women answered "yes" to continuing treatment with this OC. CONCLUSION: The OC containing 3 mg of drospirenone and 30 mcg of ethinyl estradiol has beneficial effects on bleeding pattern, symptoms of water retention and patient satisfaction. Language: English Keywords: EUROPE | MIDDLE EAST | CANADA | RESEARCH REPORT | CLINICAL RESEARCH | PROSPECTIVE STUDIES | KAP SURVEYS | WOMEN | BLEEDING | SATISFACTION | ORAL CONTRACEPTIVES, COMBINED | ESTRADIOL | CONTRACEPTIVE SAFETY | AMENORRHEA | METRORRHAGIA | Developed Countries | North America, Northern | Americas | Research Methodology | Studies | Surveys | Sampling Studies | Demographic Factors | Population | Signs and Symptoms | Diseases | Psychological Factors | Behavior | Oral Contraceptives | Contraceptive Methods | Contraception | Family Planning | Estrogens | Hormones | Endocrine System | Physiology | Biology | Safety | Public Health | Health | Menstruation Disorders Document Number: 341103 |
| 2. Peer Reviewed Title: Serum levonorgestrel levels and endometrial thickness during extended use of the levonorgestrel-releasing intrauterine system. Author: Hidalgo MM; Hidalgo-Regina C; Bahamondes MV; Monteiro I; Petta CA; Bahamondes L Source: Contraception. 2009 Jul;80(1):84-9. Abstract: BACKGROUND: The levonorgestrel-releasing intrauterine system (LNG-IUS) is a contraceptive method approved for five years of use. However, there is some evidence that its life span may be longer. The aim of the study was to evaluate serum levonorgestrel (LNG) and estradiol (E(2)) levels and endometrial thickness every 6 months from 7 to 8 1/2 years after insertion. STUDY DESIGN: At the end of the approved 5-year life span, no replacement devices were available; therefore, 86 women were allowed to retain the same device for a further 2 years. At the 7-year follow-up visit, the women who consented were again allowed to retain the same device for a further 18 months and were followed-up at six-monthly intervals. At each visit, vaginal sonography was performed to measure endometrial thickness, and a blood sample was taken to measure LNG and E(2). RESULTS: Eighty-four months after insertion, 67 women aged 34.3+/-0.8 years (mean+/-SEM) (range, 25-49 years) returned for follow-up. Mean+/-SEM LNG levels decreased from an initial 253+/-27 pg/mL (range, 86-760) during the first 2 months following insertion to 137+/-12 (range, 23-393) at 84 months and 119+/-9 pg/mL (range, 110-129) at 102 months of use (+/-SEM). At 84 months of use, mean+/-SEM endometrial thickness was 2.8+/-0.1 mm, increasing to 3.8+/-0.5 mm at 102 months of use. The incidence of amenorrhea decreased from 41.8% at 84 months to 31.5% at 102 months of use. No correlation was found between LNG levels and bleeding patterns; however, a weak correlation was found between high body mass index (kg/m(2)), high weight, and low serum LNG levels. E(2) levels were similar to those of the follicular phase of the menstrual cycle of regularly menstruating women. CONCLUSIONS: During extended use of the LNG-IUS, serum LNG levels were nearly half those found in the first 2 months of use (Wilcoxon signed rank test); serum E(2) levels were normal. Despite the very thin endometrium, menstrual bleeding was reinstated in many cases. At the end of its 5-year life span, there is a window for changing the LNG-IUS, and physicians and users should not be concerned about delaying replacement of the device for a short time beyond the approved life span; however, maintaining the same device long after its approved life span cannot be recommended. Language: English Keywords: BRAZIL | RESEARCH REPORT | FAMILY PLANNING ACCEPTORS | IUD, HORMONE RELEASING | LEVONORGESTREL | ESTRADIOL | ENDOMETRIUM | TIME FACTORS | ULTRASONICS | HEMATOLOGIC TESTS | AMENORRHEA | INCIDENCE | MENSTRUATION | South America, Eastern | South America | Latin America | Americas | Developing Countries | Family Planning Programs | Family Planning | IUD | Contraceptive Methods | Contraception | Contraceptive Agents, Progestin | Contraceptive Agents, Female | Contraceptive Agents | Estrogens | Hormones | Endocrine System | Physiology | Biology | Uterus | Genitalia, Female | Genitalia | Urogenital System | Population Dynamics | Demographic Factors | Population | Medical Procedures | Medicine | Health Services | Delivery of Health Care | Health | Laboratory Procedures | Laboratory Examinations and Diagnoses | Examinations and Diagnoses | Menstruation Disorders | Diseases | Measurement | Research Methodology | Reproduction Document Number: 342787 |
| 3. Title: Estradiol valerate/dienogest: in oral contraception. Author: Hoy SM; Scott LJ Source: Drugs. 2009;69(12):1635-46. Abstract: Estradiol valerate/dienogest is an oral contraceptive for women that combines the natural estrogen estradiol with the 19-nortestosterone derivative dienogest in a four-phasic formulation. black triangle Estradiol valerate/dienogest demonstrated contraceptive efficacy in a large (n = 1377), noncomparative, multicentre study in women aged 18-50 years, with 13 pregnancies over 1797.5 women-years of exposure generating an unadjusted Pearl Index (PI) of 0.73 (upper limit of 95% CI 1.24) [primary endpoint]. Six of the pregnancies were attributed to method failure, resulting in an adjusted PI, based on 1786.5 women-years of exposure, of 0.34 (upper limit of 95% CI 0.73). black triangle In a double-blind study in 798 women aged 18-50 years, estradiol valerate/dienogest and ethinylestradiol/levonorgestrel demonstrated an acceptable bleeding pattern and level of cycle control, according to several co-primary endpoints. black triangle As reported in the UK manufacturer's summary of product characteristics, the unadjusted PI for women aged 18-35 years or 18-50 years in a pooled analysis of clinical studies was 1.01 (upper limit of 95% CI 1.59) and 0.79 (upper limit of 95% CI 1.23). This pooled analysis of three studies excluded those pregnancies occurring within 14 days of the cessation of therapy. black triangle Estradiol valerate/dienogest was generally well tolerated in this population, with the nature of adverse events generally similar across the studies and between estradiol valerate/dienogest and ethinylestradiol/levonorgestrel. Language: English Keywords: UNITED KINGDOM | LITERATURE REVIEW | ORAL CONTRACEPTIVES, PHASIC | ORAL CONTRACEPTIVES, SIDE EFFECTS | ADMINISTRATION AND DOSAGE | ESTRADIOL | LOW-DOSE PROGESTINS | CONTRACEPTIVE EFFECTIVENESS | PEARL'S FORMULA | MENSTRUAL CYCLE | Developed Countries | Europe, Western | Europe | Oral Contraceptives, Combined | Oral Contraceptives | Contraceptive Methods | Contraception | Family Planning | Contraceptive Safety | Safety | Public Health | Health | Drugs | Treatment | Medical Procedures | Medicine | Health Services | Delivery of Health Care | Estrogens | Hormones | Endocrine System | Physiology | Biology | Contraceptive Agents, Progestin | Contraceptive Agents, Female | Contraceptive Agents | Contraceptive Use-Effectiveness | Menstruation | Reproduction Document Number: 342469 |
| 4. Title: Why use of dienogest for the first contraceptive pill with estradiol? Author: Mueck AO; Seeger H; Buhling KJ Source: Gynecological Endocrinology. 2009 Aug 11;:1-5. Abstract: Dienogest (DNG) has the essential properties of an effective progestogen for use in a new contraceptive pill using estradiol valerate as estrogenic component - it inhibits ovulation and protects against endometrial proliferation. DNG is a derivative of norethisterone (NET), but has a cyanomethyl- instead of an ethinyl-group in C17 position which may offer a variety of benefits regarding hepatic effects. The similarity to NET is reflected in the high endometriotropy and in similar pharmacokinetics like short plasma half-live and high bioavailability. However, DNG also elicits properties of progesterone derivatives like neutrality in metabolic and cardiovascular system and considerable antiandrogenic activity, the latter increased by lack of binding to SHBG as specific property of DNG. It has no glucocorticoid and antimineralocorticoid activity and has no antiestrogenic activity with the consequence that possible beneficial estradiol effects should not be antagonized. This may be of special importance for the tolerability and safety of the first pill with estradiol valerate instead of ethinylestradiol, although well-designed postmarketing studies are still ongoing to demonstrate what can be expected on the basis of pharmacology. Language: English Keywords: GERMANY | CRITIQUE | ORAL CONTRACEPTIVES, PHASIC | LOW-DOSE PROGESTINS | ESTRADIOL | CONTRACEPTIVE SAFETY | ENDOMETRIAL EFFECTS | HEPATIC EFFECTS | CENTRAL NERVOUS SYSTEM EFFECTS | MENSTRUAL CYCLE | HORMONE REPLACEMENT THERAPY | Europe, Central | Europe | Developed Countries | Oral Contraceptives, Combined | Oral Contraceptives | Contraceptive Methods | Contraception | Family Planning | Contraceptive Agents, Progestin | Contraceptive Agents, Female | Contraceptive Agents | Estrogens | Hormones | Endocrine System | Physiology | Biology | Safety | Public Health | Health | Endometrium | Uterus | Genitalia, Female | Genitalia | Urogenital System | Central Nervous System | Menstruation | Reproduction | Treatment | Medical Procedures | Medicine | Health Services | Delivery of Health Care Document Number: 342487 |
| 5. Peer Reviewed Title: Pharmacokinetics of an oral contraceptive containing oestradiol valerate and dienogest. Author: Zeun S; Lu M; Uddin A; Zeiler B; Morrison D; Blode H Source: European Journal of Contraception and Reproductive Health Care. 2009 Jun;14(3):221-32. Abstract: OBJECTIVE: To evaluate the pharmacokinetics of a combined oral contraceptive (OC) containing oestradiol valerate/dienogest (E2V/DNG) administered according to a four-phasic dosing regimen with an oestrogen step-down and a progestin step-up over 26 days of active treatment. METHODS: This Phase I, open-label study included healthy women aged 18-50 years. Treatment consisted of the administration of E2V 3 mg for 2 days, E2V 2 mg/DNG 2 mg for 5 days, E2V 2 mg/DNG 3 mg for 17 days, E2V 1 mg for 2 days, and placebo for 2 days. RESULTS: Pharmacokinetic data were analysed in 15 women. Stable E2 concentrations were maintained throughout the study. Minimum mean serum E2 levels were 33.6-64.7 pg/ml during E2V administration. The ratio of oestrone:E2 in serum was approximately 5:1. Minimum mean serum DNG levels were 6.8-15.1 ng/ml during DNG administration. Minimum concentrations of DNG increased only slightly during each phase of the regimen during which DNG was being administered. On day 24 the geometric mean C(max), C(ave) and t((1/2)) of DNG were 82.9 ng/ml, 33.7 ng/ml and 12.2 hours, respectively; the median t(max) was 1.5 hours. Serum sex hormone-binding globulin concentrations increased by 40% (within the normal range). Cortisol binding-globulin levels remained almost unchanged. Treatment was well tolerated. CONCLUSIONS: Treatment with an OC containing E2V and DNG was well tolerated and was associated with stable E2 concentrations over 28 days. The pharmacokinetics of DNG were consistent with previous findings. Minimum serum concentrations of DNG increased only slightly during phases of the regimen during which DNG was administered. Language: English Keywords: UNITED STATES OF AMERICA | RESEARCH REPORT | CLINICAL TRIALS | ORAL CONTRACEPTIVES, PHASIC | ADMINISTRATION AND DOSAGE | CONTRACEPTIVE AGENTS, ESTROGEN | CONTRACEPTIVE AGENTS, PROGESTIN | ESTRADIOL | CONTRACEPTIVE SAFETY | HEMATOLOGICAL EFFECTS | TIME FACTORS | Developed Countries | North America | Americas | Clinical Research | Research Methodology | Oral Contraceptives, Combined | Oral Contraceptives | Contraceptive Methods | Contraception | Family Planning | Drugs | Treatment | Medical Procedures | Medicine | Health Services | Delivery of Health Care | Health | Contraceptive Agents, Female | Contraceptive Agents | Estrogens | Hormones | Endocrine System | Physiology | Biology | Safety | Public Health | Hemic System | Population Dynamics | Demographic Factors | Population Document Number: 341799 |
| 6. Title: Comparison of the effects of hormone therapy regimens, oral and vaginal estradiol, estradiol + drospirenone and tibolone, on sexual function in healthy postmenopausal women. Author: Cayan F; Dilek U; Pata O; Dilek S Source: Journal of Sexual Medicine. 2008 Jan;5(1):132-138. Abstract: Sexual dysfunction is more prevalent in postmenopausal women. The aims were to prospectively evaluate and compare the effects of hormone therapy (HT) regimens, oral and vaginal estradiol, estradiol + drospirenone and tibolone, on sexual function in healthy postmenopausal women. The study included 169 consecutive healthy postmenopausal women, and the women were divided into two groups: 111 women received HT, and 58 women received no treatment and served as a control group. As an HT, 23 women with surgically induced menopause received oral 17-b estradiol. The rest of the women with natural menopause were prospectively randomized: 22 received oral 17-b estradiol + drospirenone daily, 42 received oral tibolone, and 24 received vaginal 17-b estradiol. Sexual function was evaluated with a detailed 19-item questionnaire, the female sexual function index, including sexual desire, arousal, lubrication, orgasm, satisfaction, and pain. The differences in sexual function were compared before and 6 months after the treatment in all women. Total sexual function score increased from 19.81 +or- 7.15 to 22.9 +or- 6.44 in the HT group and decreased from 21.6 +or- 8.69 to 17.6 +or- 5.7 in the control group, revealing a significant difference from baseline to post-treatment between the two groups (P = 0.000). The highest improvement in total score and arousal was achieved with the oral 17-Beta estradiol (P = 0.000 and P = 0.000, respectively). The highest improvement in lubrication was achieved with the oral and vaginal 17-Beta estradiol groups (P = 0.000). The highest improvement in orgasm was achieved with the tibolone group (P = 0.000). The highest improvement in pain was achieved with the oral and vaginal 17-Beta estradiol groups (P = 0.000). HT provided significant improvement in sexual function compared to women receiving no treatment, and therefore, HT regimens should be suggested for improvement in sexual functioning of postmenopausal women. (author's) Language: English Keywords: TURKEY | RESEARCH REPORT | PROSPECTIVE STUDIES | CASE CONTROL STUDIES | CLINICAL RESEARCH | COMPARATIVE STUDIES | KAP SURVEYS | WOMEN | HORMONE REPLACEMENT THERAPY | MENOPAUSE | ESTRADIOL | SEX BEHAVIOR | LUBRICANTS | SATISFACTION | PAIN | Europe, Southeastern | Europe | Developing Countries | Studies | Research Methodology | Surveys | Sampling Studies | Demographic Factors | Population | Treatment | Medical Procedures | Medicine | Health Services | Delivery of Health Care | Health | Reproduction | Estrogens | Hormones | Endocrine System | Physiology | Biology | Behavior | Ingredients and Chemicals | Psychological Factors | Signs and Symptoms | Diseases Document Number: 323235 |
| 7. Peer Reviewed Title: Ovulation inhibition with four variations of a four-phasic estradiol valerate / dienogest combined oral contraceptive: Results of two prospective, randomized, open-label studies. Author: Endrikat J; Parke S; Trummer D; Schmidt W; Duijkers I Source: Contraception. 2008 Sep;78(3):218-225. Abstract: Attempts to improve the tolerability of combined oral contraceptives (COCs) have included the substitution of ethinylestradiol (EE) with 17ß-estradiol (E2). However, this has proved unsatisfactory, specifically in terms of cycle control. To improve upon the poor cycle control seen previously, E2 [in the form of estradiol valerate (E2V); 1 mg of E2V contains 0.76 mg of E2] was combined with dienogest (DNG) in a novel four-phasic regimen. In the current studies, the ovulation-inhibition potency of four variations of this regimen was assessed. Two randomized, open-label, Phase II studies were performed. The first study compared two regimens (Regimens 1A and 2A) with similar dosages of DNG but different lengths of application. Having established in Study 1 that the length of application of Regimen 2A was most suitable, but that the dosages of DNG were too low for effective ovulation inhibition, a second study, which compared two regimens (Regimens 2B and 2C) with similar lengths of application but with increased dosages of DNG, was undertaken. The primary efficacy variable in both studies was the proportion of women with a Hoogland score of 5 or 6 during Cycle 2. The full analysis set comprised 192 and 203 women in Studies 1 and 2, respectively. In Study 1, 10 women (10.9%) in Regimen 1A and 6 women (6.4%) in Regimen 2A had a Hoogland score of 5 or 6. In Study 2, three women (3.1%) in Regimen 2B and one woman (1.0%) in Regimen 2C had a Hoogland score of 5 or 6. There were no safety concerns with any of the regimens. The results of these studies identified a four-phasic COC preparation comprising E2V/DNG that provides efficient ovulation inhibition. It is expected that this regimen will lead to an innovative COC containing E2 instead of EE. (author's) Language: English Keywords: GERMANY | NETHERLANDS | RESEARCH REPORT | PROSPECTIVE STUDIES | CLINICAL TRIALS | ORAL CONTRACEPTIVES, COMBINED | ESTRADIOL | OVULATION SUPPRESSION | CONTRACEPTIVE EFFECTIVENESS | CONTRACEPTIVE SAFETY | Europe, Central | Europe | Developed Countries | Europe, Western | Studies | Research Methodology | Clinical Research | Oral Contraceptives | Contraceptive Methods | Contraception | Family Planning | Estrogens | Hormones | Endocrine System | Physiology | Biology | Contraceptive Mode of Action | Safety | Public Health | Health Document Number: 328124 |
| 8. Title: Combination injectable contraceptives for contraception. Author: Gallo MF; Grimes DA; Lopez LM; Schulz KF; d'Arcangues C Source: Cochrane Database of Systematic Reviews. 2008;(4):CD004568. Abstract: BACKGROUND: Combination injectable contraceptives provide a highly effective, reversible method of preventing pregnancy, and they do not require daily administration or use at the time of coitus. Although they are used in many countries, their acceptability could be limited by method characteristics, such as the need to obtain a monthly injection or bleeding pattern changes. OBJECTIVES: To assess the contraceptive efficacy, bleeding patterns, discontinuation, user preferences, and side effects of combination injectable contraceptives. SEARCH STRATEGY: We searched computerized databases for randomized controlled trials of combination injectable contraceptives. SELECTION CRITERIA: Randomized controlled trials were eligible if they compared a combination injectable with any other contraceptive method (e.g., a second combination injectable contraceptive, progestin-only injectable contraceptive, other hormonal contraceptive or barrier method) or placebo. We limited the review to currently marketed combination injectable contraceptives. DATA COLLECTION AND ANALYSIS: One author evaluated all titles and abstracts from the literature searches to determine their eligibility. Two authors independently extracted data from the eligible trials. Data on contraceptive efficacy, bleeding patterns, continuation, and side effects were entered and analyzed with RevMan. MAIN RESULTS: Combination injectable contraceptives include depot medroxyprogesterone acetate (DMPA) 25 mg plus estradiol cypionate (E(2)C) 5 mg, as well as norethisterone enanthate (NET-EN) 50 mg plus estradiol valerate (E(2)V) 5 mg. These contraceptives resulted in lower rates of early study discontinuation due to amenorrhea or other bleeding problems than progestin-only contraceptives. However, rates were higher for overall discontinuation and discontinuation due to other medical reasons. Acceptability results favored the combination injectable in one study and the progestin-only in another.Studies comparing two combination injectable contraceptives found that NET-EN 50 mg plus E(2)V 5 mg resulted in less overall discontinuation and less discontinuation due to amenorrhea or prolonged bleeding than DMPA 25 mg plus E(2)C 5 mg. However, these differences were not detected in all trials. The NET-EN plus E(2)V group also had more regular bleeding and fewer prolonged bleeding reference periods than the DMPA plus E(2)C group. The groups did not differ in their amenorrhea rates. AUTHORS' CONCLUSIONS: While discontinuation rates can be viewed as a measure of method acceptability, the findings should be interpreted with caution since discontinuation depends on many factors. Future research should be directed toward interventions to improve the acceptability of combination injectable contraceptives, such as providing injections in settings more convenient than clinics, methods for women to administer their own injections, and counseling about possible bleeding pattern changes. Language: English Keywords: GLOBAL | LITERATURE REVIEW | RESEARCH REPORT | CONTRACEPTIVE USAGE | INJECTABLES | ADMINISTRATION AND DOSAGE | MEDROXYPROGESTERONE ACETATE | ESTRADIOL | AMENORRHEA | BLEEDING | CONTRACEPTIVE USE-EFFECTIVENESS | CONTRACEPTIVE METHOD ACCEPTABILITY | Contraception | Family Planning | Contraceptive Methods | Drugs | Treatment | Medical Procedures | Medicine | Health Services | Delivery of Health Care | Health | Contraceptive Agents, Progestin | Contraceptive Agents, Female | Contraceptive Agents | Estrogens | Hormones | Endocrine System | Physiology | Biology | Menstruation Disorders | Diseases | Signs and Symptoms | Contraceptive Effectiveness Document Number: 329618 |
9.  Title: Effect of oral contraceptive with and without associated estriol on ultrasound measurements of breast fibroadenoma: Randomized clinical trial. Author: Estevao RA; Nazario AC; Baracat EC Source: Sao Paulo Medical Journal. 2007 Sep 6;125(5):275-280. Abstract: Fibroadenomas are the most common benign tumors of the female breast. The aim of this study was to evaluate the proliferative activity of breast fibroadenoma as shown by ultrasound measurements, following administration of oral contraceptives with and without associated estriol. This was a randomized, double-blind, placebo-controlled clinical trial carried out in the Mastology Sector, Department of Gynecology, Universidade Federal de Sao Paulo. We studied 33 women with fibroadenomas. Ten were placed in group 1 and took an oral contraceptive consisting of levonorgestrel and ethinyl estradiol together with placebo material in the same capsule, for four consecutive cycles with a seven-day interval between them. The other 23 patients constituted group 2 and took the oral contraceptive as above together with estriol in the same capsule, in the same way as done by the group 1 patients. We took ultrasound measurements of their tumors (in three dimensions) before and after the intake of medication. At theend of the study, all the patients had their tumors removed by surgery. We observed decreased fibroadenoma width among the users of oral contraceptives with placebo, and this decrease was statistically significant. In the other group, we did not observe any changes (in width, length or height). The results confirm that estriol may block the protective effect of oral contraceptives on fibroadenomas, since we observed decreased fibroadenoma width among the group 1 patients but not the group 2 patients. (author's) Language: English Keywords: BRAZIL | RESEARCH REPORT | CLINICAL TRIALS | WOMEN IN DEVELOPMENT | ULTRASONICS | ORAL CONTRACEPTIVES | ESTRIOL | BREAST EXAM | FIBROADENOSIS | ORAL CONTRACEPTIVES, SIDE EFFECTS | CONTRACEPTIVE EFFECTIVENESS | South America, Eastern | South America | Latin America | Americas | Developing Countries | Clinical Research | Research Methodology | Economic Development | Economic Factors | Medical Procedures | Medicine | Health Services | Delivery of Health Care | Health | Contraceptive Methods | Contraception | Family Planning | Estrogens | Hormones | Endocrine System | Physiology | Biology | Physical Examinations and Diagnoses | Examinations and Diagnoses | Diseases | Contraceptive Safety | Safety | Public Health Document Number: 324121 |
| 10. Title: Efficacy of estriol in inhibiting epithelial proliferation in mammary fibroadenoma: randomized clinical trial. Author: Estevao RA; Baracat EC; Logullo AF; Oshima CT; Nazario AC Source: Sao Paulo Medical Journal. 2007 Nov 1;125(6):343-50. Abstract: CONTEXT AND OBJECTIVE: Mammary fibroadenoma is a disease that affects a large number of women of reproductive age. The aim of this study was to evaluate the proliferative activity of mammary fibroadenoma through expression of Ki-67 and c-myc antigens, following administration of oral contraceptive with or without estriol. DESIGN AND SETTING: Placebo-controlled double-blind randomized clinical trial in the Mastology Sector of the Department of Gynecology, Universidade Federal de Sao Paulo. METHODS: Thirty-three fibroadenoma patients were studied. Ten women (group 1) took an oral contraceptive constituted by levonorgestrel and ethinyl estradiol together with placebo manufactured in the same capsule for four consecutive cycles with a seven-day interval between them. The other 23 patients (group 2) took the same oral contraceptive together with estriol, which was put into the same capsule and used in the same way as among the group 1 patients. After four cycles, the nodules were surgically removed andsent for immunohistochemical analysis of Ki-67 and c-myc expression. RESULTS: The Ki-67 and c-myc analysis did not reveal any significant differences between the study groups. The values were 9.16 and 10.54 for group 1 and 10.86 and 17.03 for group 2, respectively. There was a tendency towards higher expression of antigens in group 2. CONCLUSION: Our results showed that there was no significant statistical difference in Ki-67 and c-myc expression between our study groups, but only a tendency towards higher expression among users of oral contraceptives containing estriol. Language: English Keywords: BRAZIL | RESEARCH REPORT | CLINICAL TRIALS | DOUBLE-BLIND STUDIES | WOMEN | MAMMARY GLAND EFFECTS | FIBROIDS | HORMONE REPLACEMENT THERAPY | ORAL CONTRACEPTIVES | ANTIGENS | ESTRIOL | LEVONORGESTREL | ETHINYL ESTRADIOL | ORAL CONTRACEPTIVES, COMBINED | ORAL CONTRACEPTIVES, SIDE EFFECTS | Developing Countries | South America, Eastern | South America | Latin America | Americas | Clinical Research | Research Methodology | Studies | Demographic Factors | Population | Physiology | Biology | Neoplasms, Benign | Neoplasms | Diseases | Treatment | Medical Procedures | Medicine | Health Services | Delivery of Health Care | Health | Contraceptive Methods | Contraception | Family Planning | Immunologic Factors | Immunity | Immune System | Estrogens | Hormones | Endocrine System | Contraceptive Agents, Progestin | Contraceptive Agents, Female | Contraceptive Agents | Contraceptive Agents, Estrogen | Contraceptive Safety | Safety | Public Health Document Number: 329806 |
| 11. Peer Reviewed Title: Monthly injectable contraceptive use by adolescents in Brazil: Evaluation of clinical aspects. Author: Guazzelli CA; Jacobucci MS; Barbieri M; Araujo FF; Moron AF Source: Contraception. 2007 Jul;76(1):45-48. Abstract: This prospective noncomparative observational study evaluated the clinical symptoms, body weight and blood pressure of 38 adolescents receiving a monthly injectable contraceptive containing estradiol valerate 5 mg and norethisterone 50 mg. The volunteers, aged 16-19 years, were examined monthly during 1 year and asked about the following symptoms at baseline: dysmenorrhea, headache, breast tenderness, leg pain and irritability. There was a constant and gradual decline in each of the above symptoms over time, and there was a statistically significant difference between symptoms reported at the first visit and subsequent appointments. Body weight and blood pressure did not change significantly during the 1-year period. No pregnancies were observed. These findings suggest that monthly injectable contraception with estradiol valerate 5 mg/norethisterone 50 mg represents a highly effective and well-tolerated contraceptive for teens. (author's) Language: English Keywords: BRAZIL | RESEARCH REPORT | PROSPECTIVE STUDIES | ADOLESCENTS, FEMALE | PREMENSTRUAL TENSION | EXAMINATIONS AND DIAGNOSES | INJECTABLES | ESTRADIOL | NORETHINDRONE | ADMINISTRATION AND DOSAGE | BODY WEIGHT | BLOOD PRESSURE | South America, Eastern | South America | Latin America | Americas | Developing Countries | Studies | Research Methodology | Adolescents | Youth | Age Factors | Population Characteristics | Demographic Factors | Population | Menstruation Disorders | Diseases | Medical Procedures | Medicine | Health Services | Delivery of Health Care | Health | Contraceptive Methods | Contraception | Family Planning | Estrogens | Hormones | Endocrine System | Physiology | Biology | Contraceptive Agents, Progestin | Contraceptive Agents, Female | Contraceptive Agents | Drugs | Treatment | Hemic System Document Number: 317957 |
| 12. Title: Pharmacokinetics and pharmacodynamics of drospirenone-estradiol combination hormone therapy product coadministered with hydrochlorothiazide in hypertensive postmenopausal women. Author: Karara AH; Hanes V; Alonso A; Ni P; Poola N Source: Journal of Clinical Pharmacology. 2007;47:1292-1302. Abstract: The effects of combination hormone therapy of drospirenone (DRSP), a novel progestin with antialdosterone properties, and 17 beta-estradiol (E2) on hydrochlorothiazide (HCTZ) pharmacokinetics/pharmacodynamics versus placebo were investigated in a double-blind, placebo-controlled, crossover study. Thirty-six postmenopausal women with stage 1 hypertension maintained on 25 mg of HCTZ once daily were randomized to receive either 3 mg of DRSP/1 mg of E2 or placebo once daily for 4 weeks. Plasma HCTZ, serum DRSP, E2, potassium, aldosterone, and plasma renin activity were determined at baseline and after 4 weeks. Results showed that the combination of DRSP/E2 plus 25 mg of HCTZ is safe and well tolerated in hypertensive postmenopausal women. The pharmacokinetics of HCTZ were not affected by coadministration of DRSP/E2. The geometric mean ratios and 90% confidence intervals ([HCTZ + DRSP/E2]/[HCTZ + placebo]) for HCTZ (a) area under the serum/plasma concentration-time curve from 0 to 24 hours and (b) maximum plasma concentration were 101 (90.7, 112) and 103 (92.8, 115), respectively. In the HCTZ + DRSP/E2 group, serum potassium, aldosterone, and plasma renin activity all increased in a manner marginally consistent with a beneficial antialdosterone effect, counteracting the HCTZ-induced potassium loss and lowering both systolic and diastolic blood pressure. No dose adjustment is required when DRSP/E2 is added to antihypertensive therapy with HCTZ in hypertensive postmenopausal women. (author's) Language: English Keywords: UNITED STATES OF AMERICA | RESEARCH REPORT | DOUBLE-BLIND STUDIES | WOMEN | MIDDLE AGED ADULTS | OLDER ADULTS | HYPERTENSION | HORMONE REPLACEMENT THERAPY | ESTRADIOL | ADMINISTRATION AND DOSAGE | TIME FACTORS | METABOLIC EFFECTS | Developed Countries | North America | Americas | Studies | Research Methodology | Demographic Factors | Population | Adults | Age Factors | Population Characteristics | Vascular Diseases | Diseases | Treatment | Medical Procedures | Medicine | Health Services | Delivery of Health Care | Health | Estrogens | Hormones | Endocrine System | Physiology | Biology | Drugs | Population Dynamics Document Number: 322642 |
| 13. Peer Reviewed Title: Once-a-month contraceptive pills in China: A review of available evidence. Author: Kejuan F; Meirik O; Yongang D; Yan C; Weijin Z Source: Contraception. 2007 May;75(5):337-343. Abstract: A review of evidence was conducted to assess the safety, effectiveness and continuation of once-a-month contraceptive pills. Papers were identified by electronic searches in Chinese and international databases and manual searches of Chinese journals and index of family planning literature. Data on pharmacokinetics, clinical performance and laboratory examinations were extracted from 17 papers of mixed quality on pills containing quinestrol 3 mg and norgestrel 12 mg (Quin-Ng) or levonorgestrel 6 mg (Quin-Lng) used by women in China. Quin-Lng pills gave steady-state serum levels of ethinylestradiol between 0.20-0.25 and 0.15 ng/mL. The 1-year perfect use pregnancy rate was 1.1 per 100 women-years. Nausea and increased leukorrhea were common; bleeding control was good. Hypertension developed in 5.8% of Quin-Ng pill users during the first year of use. For Quin-Ng and Quin-Lng once-a-month pills, 1 year continuation rates were 73.6 and 82.1 per 100, respectively. Lack of good quality data prevents confident assessment of the safety and efficacy of once-a-month pills. Short-term safety information indicates a high incidence of bothersome side effects and hypertension. The high monthly estrogen and progestogen doses raise questions about the safety of the once-a-month pills. (author's) Language: English Keywords: CHINA | LITERATURE REVIEW | CLINICAL TRIALS | WOMEN | ORAL CONTRACEPTIVES | QUINESTROL | NORGESTREL | LEVONORGESTREL | ADMINISTRATION AND DOSAGE | SIDE EFFECTS | SAFETY | CONTRACEPTIVE USE-EFFECTIVENESS | Developing Countries | Asia, Eastern | Asia | Clinical Research | Research Methodology | Demographic Factors | Population | Contraceptive Methods | Contraception | Family Planning | Estrogens | Hormones | Endocrine System | Physiology | Biology | Contraceptive Agents, Progestin | Contraceptive Agents, Female | Contraceptive Agents | Drugs | Treatment | Medical Procedures | Medicine | Health Services | Delivery of Health Care | Health | Public Health | Contraceptive Effectiveness Document Number: 313401 |
| 14. Title: Efficacy and tolerability of estradiol 1mg and drospirenone 2mg in postmenopausal Korean women: A double-blind, randomized, placebo-controlled, multicenter study. Author: Lee BS; Kang BM; Yoon BK; Choi H; Park HM Source: Maturitas. 2007 Aug 20;57(4):361-369. Abstract: The aim of this study was to demonstrate that the therapeutic efficacy of an estradiol 1 mg/drospirenone 2mg (E2/DRSP) preparation is superior to a placebo in postmenopausal Korean women with hot flushes and other climacteric symptoms, and to demonstrate that this treatment is both safe and tolerable. This was a double-blind, randomized, placebo-controlled, multicenter study over four 28-day treatment cycles. A total of 158 subjects were screened and 90 women were randomized into two treatment groups (E2/DRSP group, n = 45; placebo group, n = 45). The primary efficacy parameter was the individual relative change of hot flushes. The secondary efficacy parameters such as other climacteric, urogenital symptoms and vaginal bleeding patterns were also evaluated, and the occurrence of any adverse events was noted. In addition, physical, gynecological examinations and laboratory analyses were performed at the beginning and end of the study. The mean number of hot flushes per week during treatment weeks 3-16 decreased by 48.1% during treatment with placebo, and by 84.4% during treatment with E2/DRSP (p < 0.001). The E2/DRSP combination also reduced the incidence and intensity of menopausal symptoms in postmenopausal women. Most of adverse events was mild or moderate degree of intensity. None of the parameters measured in the study, including laboratory analyses, physical and gynecological examinations, vital signs, and weight, led to any concerns of safety. The E2 1 mg/DRSP 2mg combination tested in the study was efficacious and safe in the treatment of hot flushes and other climacteric symptoms in postmenopausal Korean women. (author's) Language: English Keywords: REPUBLIC OF KOREA | RESEARCH REPORT | DOUBLE-BLIND STUDIES | WOMEN | MIDDLE AGED ADULTS | MENOPAUSE | HORMONE REPLACEMENT THERAPY | ESTRADIOL | SIGNS AND SYMPTOMS | SIDE EFFECTS | SAFETY | Asia, Eastern | Asia | Developed Countries | Studies | Research Methodology | Demographic Factors | Population | Adults | Age Factors | Population Characteristics | Reproduction | Treatment | Medical Procedures | Medicine | Health Services | Delivery of Health Care | Health | Estrogens | Hormones | Endocrine System | Physiology | Biology | Diseases | Public Health Document Number: 318717 |
| 15. Title: Modified vitrification method for cryopreservation of human ovarian tissues. Author: Li YB; Zhou CQ; Yang GF; Wang Q; Dong Y Source: Chinese Medical Journal. 2007 Jan 20;120(2):110-114. Abstract: Vitrification is a prospective technology in ovarian tissue cryopreservation, but it is still in an initial stage. This study was conducted to investigate a modified vitrification protocol for human ovarian tissue, which can be used as an alternative to preserve fertility for young women with cancer who have to undergo cytotoxic therapy and sterilization. Ovarian tissue samples were collected from 15 patients and randomly allocated to groups of fresh, vitrification, and conventional slow freezing. A modified carrierless vitrification method was applied. The proportion of morphologically intact follicles in fresh ovarian tissues was compared with that in warmed/thawed tissues. The initial growth of the follicles and the concentrations of estradiol and progesterone were detected to determine the viability and endocrine function of the cryopreserved tissues. The proportion of morphologically intact primordial follicles in the fresh group (97.6%) was significantly higher than that in the other two groups (vitrification group 80.3% and slow-freezing group 72.6%, P<0.001). In both the vitrification and slow-freezing groups, estradiol and progesterone were secreted continuously during 2-week culture in vitro, the proportion of primary follicles were both significantly increased compared to the fresh group. No statistically significant differences existed between the two groups after cryopreservation in the proportion of both primordial and primary follicles, and the concentrations of estradiol and progesterone (P>0.05). The modified vitrification method for cryopreservation of human ovarian tissues is effective, simple, and inexpensive. (author's) Language: English Keywords: CHINA | RESEARCH REPORT | EVALUATION | WOMEN | OVARIAN CANCER | CYTOLOGY | ESTRADIOL | PROGESTERONE | TECHNOLOGY | Asia, Eastern | Asia | Developing Countries | Demographic Factors | Population | Cancer | Neoplasms | Diseases | Biology | Estrogens | Hormones | Endocrine System | Physiology | Progestational Hormones | Economic Factors Document Number: 319863 |
| 16. Peer Reviewed Title: Effect of single administration of levonorgestrel on the menstrual cycle. Author: Okewole IA; Arowojolu AO; Odusoga OL; Oloyede OA; Adeleye OA Source: Contraception. 2007 May;75(5):372-377. Abstract: Levonorgestrel (LNG) 1.5 mg administered within 72 h of unprotected coitus is an established method of emergency contraception. Currently, there is some, although incomplete, knowledge about the mechanism of action. We administered 1.5 mg LNG peri-ovulatory to determine the effects on serum gonadotrophins, estradiol and progesterone levels. Fourteen women were studied in a pretreatment and treatment cycle; eight women (Group A) took LNG 3 days before the expected day of ovulation, while 6 (Group B) took LNG a day before the expected day of ovulation. The women in Group A had a significant delay in their LH peak and onset of the next menses compared with their pretreatment cycles (26.4 vs. 39.1 days, p < .05). Those in Group B had no significant changes in the endocrine parameters but there was a significant shortening of the mean cycle length in comparison with their pretreatment cycles (25.1 vs. 20.2 days). Levonorgestrel 1.5 mg acts as an emergency contraception by delaying the LH surge and interfering with ovulation. It may also disrupt corpus luteum formation causing premature luteinization of unruptured follicles. (author's) Language: English Keywords: NIGERIA | RESEARCH REPORT | WOMEN | MENSTRUAL CYCLE | LEVONORGESTREL | ADMINISTRATION AND DOSAGE | GONADOTROPINS | ESTRADIOL | PROGESTERONE | EVALUATION | CORPUS LUTEUM HORMONES | EMERGENCY CONTRACEPTION | Africa, Western | Africa, Sub Saharan | Africa | Developing Countries | Demographic Factors | Population | Menstruation | Reproduction | Contraceptive Agents, Progestin | Contraceptive Agents, Female | Contraceptive Agents | Contraception | Family Planning | Drugs | Treatment | Medical Procedures | Medicine | Health Services | Delivery of Health Care | Health | Hormones | Endocrine System | Physiology | Biology | Estrogens | Progestational Hormones Document Number: 313403 |
| 17. Peer Reviewed Title: Oxytocin antagonists may improve infertility treatment. Author: Pierzynski P; Reinheimer TM; Kuczynski W Source: Fertility and Sterility. 2007 Jul;88(1):213.e19-213.e22. Abstract: The objective was to confirm the improvement of uterine receptivity following administration of oxytocin and vasopressin V1A antagonist atosiban. Design: Case report. Setting: Private reproductive medicine center. A 42-year-old woman with a history of 15 years' infertility and seven failed in vitro fertilization/embryo transfer (IVF-ET) attempts was the patient used for the study. Intervention(s): Atosiban (mixed vasopressin V1A/oxytocin antagonist registered for the treatment of imminent premature birth) was administered on the 14th day of endometrial synchronization for oocyte donation. Main Outcome Measure(s): Uterine contractile activity (component of uterine receptivity) and success of treatment of infertility. Intense spontaneous uterine contractility was visualized by transvaginal sonography. After 1 hour of intravenous infusion of atosiban, a repeated scan showed a significant decrease in contractile activity (11 vs 7 contractions per 4 minutes, respectively). The ET was performed immediately after, and the infusion of atosiban continued for the next 2 hours. The treatment decreased the uterine contractile activity and resulted in successful embryo implantation and a normal twin diamniotic pregnancy. Atosiban may improve uterine receptivity during ET and may increase success rates of advanced infertility treatment procedures. (author's) Language: English Keywords: POLAND | RESEARCH REPORT | WOMEN | INFERTILITY | TREATMENT | OXYTOCIN | HORMONE ANTAGONISTS | ESTRADIOL | PROGESTERONE | ADMINISTRATION AND DOSAGE | IMPLANTATION | PREGNANCY | Developing Countries | Europe, Central | Europe | Demographic Factors | Population | Reproduction | Medical Procedures | Medicine | Health Services | Delivery of Health Care | Health | Pituitary Hormones | Hormones | Endocrine System | Physiology | Biology | Estrogens | Progestational Hormones | Drugs | Pregnancy, First Trimester Document Number: 318319 |
| 18. Peer Reviewed Title: Monthly injectable contraceptives and the risk of all cancers combined and site-specific cancers in Shanghai. Author: Rosenblatt KA; Gao DL; Ray RM; Nelson ZC; Wernli KJ Source: Contraception. 2007 Jul;76(1):40-44. Abstract: The risk of 12 types of cancer in relation to use of monthly injectable contraceptives was assessed in a prospective study in Shanghai, China. From 1989 to 1991, an in-person interview was administered to 267,400 female textile workers to ascertain information on risk factors for breast cancer, contraceptive use and induced abortions. The cohort was followed until July 2000 for incident cancer cases. Cox proportional hazards analysis was used to calculate incidence rate ratios for specific types of cancer in women who ever had used monthly injectable contraceptives and by length of use. There was a reduced risk of uterine corpus cancer for women who had ever used monthly injectable contraceptives. No association was observed between the use of monthly injectable contraceptives and the risk of all cancers combined and for any of the 11 other cancers considered. There appears to be no evidence of an increased risk of cancer after exposure to monthly injectable contraceptives in our study. (author's) Language: English Keywords: CHINA | RESEARCH REPORT | PROSPECTIVE STUDIES | QUESTIONNAIRES | WOMEN | WORKERS | ESTRADIOL | ADMINISTRATION AND DOSAGE | INJECTABLES | TIME FACTORS | RISK FACTORS | CANCER | Developing Countries | Asia, Eastern | Asia | Studies | Research Methodology | Demographic Factors | Population | Labor Force | Human Resources | Economic Factors | Estrogens | Hormones | Endocrine System | Physiology | Biology | Drugs | Treatment | Medical Procedures | Medicine | Health Services | Delivery of Health Care | Health | Contraceptive Methods | Contraception | Family Planning | Population Dynamics | Neoplasms | Diseases Document Number: 317956 |
| 19. Title: Total salpingectomy during abdominal hysterectomy: Effects on ovarian reserve and ovarian stromal blood flow. Author: Sezik M; Ozkaya O; Demir F; Sezik HT; Kaya H Source: Journal of Obstetrics and Gynaecology Research. 2007 Dec;33(6):863-869. Abstract: The aim was to investigate the short- and medium-term consequences of performing total salpingectomy during abdominal hysterectomy (without oophorectomy) on certain ovarian reserve parameters and blood flow velocity measurements through the ovarian stroma. Twenty-four patients were recruited and randomized into two groups. Group 1 patients (n = 12) underwent total hysterectomy and complete excision of the fallopian tubes bilaterally. In group 2 (classical approach), fallopian tubes were removed partially leaving behind the neighboring paraovarian tissue. Pre- and postoperative (at 1 and 6 months) serum follicle stimulating hormone (FSH), luteinizing hormone (LH), estradiol values, ovarian volume estimation by transvaginal ultrasound, and ovarian stromal blood flow Doppler velocimetry were assessed during the early follicular phase. Mann-Whitney U-test, Student's t-test and Freidman's test were used for comparisons. Baseline data were similar across the groups (P > 0.05). Mean FSH, LH, estradiol values, and ovarian volume were unchanged after both of the techniques. However, mean pulsatility index, resistance index, and systole/diastole (S/D) ratio were significantly decreased in both groups compared to baseline values (group 1, P = 0.027, P = 0.018, and P = 0.013, respectively; group 2, P = 0.01, P = 0.002, and P = 0.0001, respectively). Postoperative decline in the mean pulsatility index was more pronounced (P = 0.02) in group 2 (partial removal). It appears that complete removal of fallopian tubes during hysterectomy has no advantageous effect on ovarian blood supply. It might be important to protect the ovarian blood supply as much as possible while performing hysterectomy in the reproductive period. (author's) Language: English Keywords: TURKEY | RESEARCH REPORT | CLINICAL RESEARCH | CASE CONTROL STUDIES | WOMEN IN DEVELOPMENT | HYSTERECTOMY | OVARIAN EFFECTS | FOLLICLE STIMULATING HORMONE | LUTEINIZING HORMONE | ESTRADIOL | ULTRASONICS | BLOOD PRESSURE | TUBAL EXCISION | Europe, Southeastern | Europe | Developing Countries | Research Methodology | Studies | Economic Development | Economic Factors | Gynecologic Surgery | Urogenital Surgery | Surgery | Treatment | Medical Procedures | Medicine | Health Services | Delivery of Health Care | Health | Ovary | Genitalia, Female | Genitalia | Urogenital System | Physiology | Biology | Gonadotropins, Pituitary | Gonadotropins | Hormones | Endocrine System | Estrogens | Hemic System | Tubal Occlusion | Female Sterilization | Sterilization, Sexual | Family Planning Document Number: 322693 |
| 20. Title: Endothelial function across an oral contraceptive cycle in women using levonorgestrel and ethinyl estradiol. Author: Torgrimson BN; Meendering JR; Kaplan PF; Minson CT Source: American Journal of Physiology, Heart and Circulatory Physiology. 2007 Jun;292(6):H2874-H2580. Abstract: Oral contraceptive pills (OCPs) are a popular contraception method. Currently, lower-dose ethinyl estradiol formulations are most commonly prescribed, although they have been linked to increased arterial vascular risk. The aim of this study was to investigate endothelial function in healthy young women using lower-dose ethinyl estradiol OCPs. We examined flow-mediated, endothelium-dependent and nitroglycerin-mediated, endotheliumin-dependent vasodilation of the brachial artery, comparing two doses of ethinyl estradiol/levonorgestrel OCPs in 15 healthy young women on two study days: once during the active phase and once during the placebo phase of an OCP cycle. Group low dose (LD) (n = 7) active pills contained 150 microg levonorgestrel/30 microg ethinyl estradiol versus Group very low dose (VLD) (n = 8) with 100 microg levonorgestrel/20 microg ethinyl estradiol. Endothelium-dependent vasodilation was lower during the active phase in Group VLD (5.33 +or- 1.77% vs. 7.23 +or- 2.60%; P = 0.024). This phase differencewas not observed in Group LD (8.00 +or- 0.970% vs. 7.61 +or- 1.07%; P = 0.647). Endotheliumin-dependent vasodilation did not differ between phases in either group. Finally, we measured endothelium-dependent vasodilation in two additional women who received 10 microg of unopposed ethinyl estradiol. Endothelium-dependent vasodilation was increased by unopposed ethinyl estradiol compared with the placebo phase (10.88 +or- 2.34% vs. 6.97 +or- 1.83%). These results suggest that levonorgestrel may antagonize the activity of ethinyl estradiol. Thus both the progestin type and estradiol dose need to be considered when assessing arterial vascular risk of OCP use in women. (author's) Language: English Keywords: UNITED STATES OF AMERICA | RESEARCH REPORT | WOMEN | ORAL CONTRACEPTIVES, COMBINED | ORAL CONTRACEPTIVES, LOW-DOSE | LEVONORGESTREL | ETHINYL ESTRADIOL | ADMINISTRATION AND DOSAGE | MENSTRUAL CYCLE | ESTRADIOL | EVALUATION | Developed Countries | North America | Americas | Demographic Factors | Population | Oral Contraceptives | Contraceptive Methods | Contraception | Family Planning | Contraceptive Agents, Progestin | Contraceptive Agents, Female | Contraceptive Agents | Contraceptive Agents, Estrogen | Drugs | Treatment | Medical Procedures | Medicine | Health Services | Delivery of Health Care | Health | Menstruation | Reproduction | Estrogens | Hormones | Endocrine System | Physiology | Biology Document Number: 320456 |
| 21. Title: Influences of hormone-based contraception on depressive symptoms in premenopausal women with major depression. Author: Young EA; Kornstein SG; Harvey AT; Wisniewski SR; Barkin J Source: Psychoneuroendocrinology. 2007 Aug;32(7):843-853. Abstract: Hormone-based contraceptives affect mood in healthy women or in women with premenstrual dysphoric disorder (PMDD). No study has yet examined their association with mood in women with major depressive disorder (MDD). The purpose of this study was to determine whether estrogen-progestin combination or progestin-only contraceptives are associated with depression severity, function and quality of life, or general medical or psychiatric comorbidity in women with MDD. This analysis focused on a large population of female outpatients less than 40 years of age with non-psychotic MDD who were treated in 18 primary and 23 psychiatric care settings across the US, using data from the Sequenced Treatment Alternatives to Relieve Depression (STAR*D) study. Baseline demographic and clinical information was gathered and compared between three groups based on hormonal use: combination (estrogen-progestin)(N = 232), progestin-only (N = 58), and no hormone treatment (N = 948). Caucasians were significantly more likely to use combined hormone contraception. Women on progestin-only had significantly more general medical comorbidities; greater hypersomnia, weight gain and gastrointestinal symptoms; and worse physical functioning than women in either of the other groups. Those on combined hormone contraception were significantly less depressed than those with no hormone treatment by the 16-item Quick Inventory of Depressive Symptomatology-Self-Rated. The combined hormone group also demonstrated better physical functioning and less obsessive-compulsive disorder (COCD) comorbidity than either of the other groups. Synthetic estrogen and progestins may influence depressive and physical symptoms in depressed women. (author's) Language: English Keywords: UNITED STATES OF AMERICA | RESEARCH REPORT | COMPARATIVE STUDIES | WOMEN | MENSTRUATION | CONTRACEPTIVE AGENTS | ESTRADIOL | PROGESTERONE | TREATMENT | SIGNS AND SYMPTOMS | DEPRESSION | Developed Countries | North America | Americas | Studies | Research Methodology | Demographic Factors | Population | Reproduction | Contraception | Family Planning | Estrogens | Hormones | Endocrine System | Physiology | Biology | Progestational Hormones | Medical Procedures | Medicine | Health Services | Delivery of Health Care | Health | Diseases | Mental Disorders Document Number: 321239 |
| 22. Peer Reviewed Title: Bone mineral density in users of two kinds of once-a-month combined injectable contraceptives. Author: Bahamondes L; Juliato CT; Villarreal M; Sobreira-Lima B; Simoes JA Source: Contraception. 2006 Sep;74(3):259-263. Abstract: The objective of this descriptive study was to compare bone mineral density (BMD) between users of two kinds of once-a-month combined injectable contraceptives (CICs) and control subjects. This cross-sectional descriptive study included 97 women aged between 20 and 45 years using CICs containing either 25 mg of medroxyprogesterone acetate and 5 mg of estradiol cypionate for 12--82 months or 50 mg of norethindrone enanthate and 5 mg of estradiol valerate for 12--60 months, matched by age (±1 year) and body mass index (BMI; kg/m2) (±1) with users of the TCu 380A intrauterine device as control subjects. BMD was evaluated at the midshaft of the ulna and at the distal section of the radius of the nondominant forearm using double X-ray absorptiometry. There was no difference in BMD between users of either CIC and nonusers at either section of the forearm studied. There was also no difference in BMD between users of the two CICs at either section of the forearm. Women aged between 20 and 45 years, currently using one of these two kinds of CICs, presented BMDs similar to those of control subjects paired by age and BMI. (author's) Language: English Keywords: BRAZIL | RESEARCH REPORT | CROSS SECTIONAL ANALYSIS | WOMEN | CONTROL GROUPS | MEDROXYPROGESTERONE ACETATE | ESTRADIOL | NORETHINDRONE ENANTHATE | INJECTABLES | ADMINISTRATION AND DOSAGE | SIDE EFFECTS | SKELETAL EFFECTS | Developing Countries | South America, Eastern | South America | Latin America | Americas | Research Methodology | Demographic Factors | Population | Contraceptive Agents, Progestin | Contraceptive Agents, Female | Contraceptive Agents | Contraception | Family Planning | Estrogens | Hormones | Endocrine System | Physiology | Biology | Norethindrone | Contraceptive Methods | Drugs | Treatment | Medical Procedures | Medicine | Health Services | Delivery of Health Care | Health Document Number: 304457 |
| 23. Peer Reviewed Title: Effects of two different oral contraceptives on homocysteine metabolism in women with polycystic ovary syndrome. Author: Cagnacci A; Tirelli A; Renzi A; Paoletti AM; Volpe A Source: Contraception. 2006 Apr;73(4):348-351. Abstract: Purpose: This study was conducted to evaluate the effects of two different oral contraceptives (OCs) on homocysteine (Hcy) metabolism in 20 women with polycystic ovary syndrome (PCOS). Methods: Women were randomly allocated to receive either the biphasic OC containing 40/30 µg ethynylestradiol (EE+25/125 µg desogestrel (DSG; n= 10) or the monophasic OC containing 35 µg EE and 2 mg cyproterone acetate (CPA; n=10). Investigations were performed before and after 6 months of treatment. Fasting vitamin B(-12), folate, Hcy and insulin sensitivity (SI), and glucose utilization independent of insulin (Sg), by the minimal model method, were evaluated. Results: Folate and vitamin B(-12) were not significantly modified by either OC. EE/DSG decreased SI (2.53±0.35 vs. 1.68±0.45; p <.05), without modifying Hcy (9.54±0.7 µmol/L vs. 9.18±0.6 µmol/L). EE/CPA improved SI (1.47±0.38 vs. 3.27±0.48; p<.04) and decreased Hcy (9.8±1.9 µmol/L vs. 7.9±0.9 µmol/L; p<.05). This study indicates that in women PCOS, EE/CPA, but not EE/DSG, improve IS and decreases fasting Hcy. (author's) Language: English Keywords: ITALY | RESEARCH REPORT | CLINICAL TRIALS | WOMEN | FAMILY PLANNING ACCEPTORS | ORAL CONTRACEPTIVES | OVARIAN CYSTS | DESOGESTREL | ESTRADIOL | METABOLIC EFFECTS | GLUCOSE METABOLISM EFFECTS | LABORATORY EXAMINATIONS AND DIAGNOSES | Europe, Southern | Europe | Developed Countries | Clinical Research | Research Methodology | Demographic Factors | Population | Family Planning Programs | Family Planning | Contraceptive Methods | Contraception | Diseases | Contraceptive Agents, Progestin | Contraceptive Agents, Female | Contraceptive Agents | Estrogens | Hormones | Endocrine System | Physiology | Biology | Carbohydrate Metabolic Effects | Examinations and Diagnoses | Medical Procedures | Medicine | Health Services | Delivery of Health Care | Health Document Number: 298527 |
| 24. Peer Reviewed Title: Hormone levels before and after tubal sterilization. Author: Gentile GP; Helbig DW; Zacur H; Park T; Lee YJ Source: Contraception. 2006 May;73(5):507-511. Abstract: The aim of this study was to determine whether women experience significant luteal phase hormonal changes following interval tubal sterilization. Design: This is a partly randomized, prospective clinical study. Setting: This study involved healthy volunteers in an academic research environment. Patients: This study involved 118 fertile women seeking tubal sterilization and 57 fertile controls with at least three normal cyclic menstrual periods before entry into the study. Interventions: The patients were randomized to bipolar cautery or Hulka clip as sterilization methods. Barrier contraception or abstinence was used by controls. Main Outcome Measures: The main outcome measures are serum estradiol and progesterone levels and urinary estradiol and pregnanediol levels obtained during the luteal phase before, 1 year and 2 years after sterilization. The women randomized to the bipolar cautery group had higher midluteal progesterone levels measured between Days 5 and 11 postovulation (15.5 ng/mL before sterilization, 14.5 ng/mL at 1 year and 14.5 ng/mL at 2 years) than did the other two groups. The clip group had progesterone levels of 14.1, 12.0 and 12.5 ng/mL at baseline, 1 year and 2 years, respectively, and the control group had levels of 12.0, 11.9 and 11.3 ng/mL for the same periods. Serum estradiol and progesterone and urinary pregnanediol and estradiol were not significantly changed over the 2-year period, nor were there significant differences between the two groups. There were no significant hormonal changes in sterilized women over a period of 2 years when compared with their baseline levels or when compared with unsterilized age-matched controls. (author's) Language: English Keywords: NEW YORK | RESEARCH REPORT | CLINICAL RESEARCH | PROSPECTIVE STUDIES | CASE CONTROL STUDIES | WOMEN | TUBAL LIGATION | ESTRADIOL | PROGESTERONE | TUBAL OCCLUSION | Developed Countries | United States of America | North America | Americas | Research Methodology | Studies | Demographic Factors | Population | Female Sterilization | Sterilization, Sexual | Family Planning | Estrogens | Hormones | Endocrine System | Physiology | Biology | Progestational Hormones Document Number: 299438 |
| 25. Title: Pubertal effects on adjustment in girls: Moving from demonstrating effects to identifying pathways. Author: Graber JA; Brooks-Gunn J; Warren MP Source: Journal of Youth and Adolescence. 2006 Jun;35(3):413-423. Abstract: The present investigation examines mediated pathways from pubertal development to changes in depressive affect and aggression. Participants were 100 white girls who were between the ages of 10 and 14 (M = 12.13, SD = .80); girls were from well-educated, middle- to upper-middle class families, and attended private schools in a major northeastern urban area. Three aspects of pubertal development were examined: (a) estradiol categories tapping gonadal maturation; (b) dehydroepiandrosterone sulfate (DHEAS) levels indicating adrenal maturation; and (c) pubertal timing (early vs. other). Three potential mediators were also examined: emotional arousal, attention difficulties, and negative life events. Tests of mediated models indicated that early pubertal timing predicted higher emotional arousal which subsequently predicted increased depressive affect. Negative life events, and possibly attention difficulties, mediated the associations of both estradiol category and DHEAS with aggression. These findings highlight the potential for more intensive investigation of gonadal and adrenal processes in explaining affective changes at puberty. (author's) Language: English Keywords: UNITED STATES OF AMERICA | RESEARCH REPORT | CLINICAL RESEARCH | ADOLESCENTS, FEMALE | WHITES | PUBERTY | AGE FACTORS | SOCIAL ADJUSTMENT | DEPRESSION | AGGRESSION | ADRENAL CORTEX HORMONES | ESTRADIOL | North America | Americas | Developed Countries | Research Methodology | Adolescents | Youth | Population Characteristics | Demographic Factors | Population | Ethnic Groups | Cultural Background | Reproduction | Social Behavior | Behavior | Mental Disorders | Diseases | Hormones | Endocrine System | Physiology | Biology | Estrogens Document Number: 312623 |
| 26. Peer Reviewed Title: Ovarian cysts in users of Implanon and Jadelle subdermal contraceptive implants. [Quiste ovárico en usuarias de implantes anticonceptivos subdérmicos Implanon y Jadelle] Author: Hidalgo MM; Lisondo C; Juliato CT; Espejo-Arce X; Monteiro I Source: Contraception. 2006 May;73(5):532-536. Abstract: Objective: To evaluate the prevalence of ovarian cysts in users of two contraceptive implants compared to users of intrauterine contraceptive (IUC). Materials and Methods: A total of 344 women were enrolled at 3 months of use of the etonogestrel-releasing implant (Implanon®), the levonorgestrel-releasing implant (Jadelle®) or the TCu380A IUC. Bimanual pelvic examination and vaginal ultrasound were performed during routine 3-, 6- and 12-month visits of asymptomatic women. Women with ovarian cysts (or enlarged ovarian follicles = 25 mm) were assessed weekly until disappearance or reduction of the image [including estradiol (E(-2)) and progesterone (P) measurement], and women with no ovarian enlargement underwent the same evaluation for the same period of time. Results: Ovarian cysts were detected in 5.2%, 13.0% and 1.9% of users of Implanon®, Jadelle® and IUC, respectively, at 3 months. At 6 months of use, prevalence was 7.2%, 8.0% and 2.1%, whereas 12-month rates were 26.7%, 14.6% and 1.2% in the three groups, respectively. E(-2) levels were significantly higher among users with ovarian cysts than controls. The time until disappearance of the ovarian cyst was similar in all three groups. There were more cases of menorrhagia in users of implants who had ovarian cysts than in those with no ovarian enlargement. Conclusions: The finding of ovarian cyst or enlarged ovarian follicles during the first year of use of Implanon® and Jadelle® implants is common and transient and should not be interpreted as a pathologic ovarian cyst. No further medical interventions are necessary. (author's) Spanish Abstract: Objetivo: Evaluar la prevalencia de quistes ováricos en usuarias de dos implantes anticonceptivos en comparación con las usuarias de anticonceptivos intrauterinos (DIU). Materiales y métodos: Se incluyó en el estudio un total de 344 mujeres a los 3 meses de uso de un implante de liberación de etonogestrel (Implanon®), de levonorgestrel (Jadelle®) o el DIU Tcu380A. Se realizaron exámenes pélvicos bimanuales y ecografías vaginales durante las visitas de rutina a los 3, 6 y 12 meses de las mujeres asintomáticas. Se realizó una revisación semanal a las mujeres con quiste ovárico (o aumento del tamaño de los folículos ováricos = 25 mm) hasta su desaparición o hasta la reducción de la imagen [incluidas las determinaciones de estradiol (E (-2)) y progesterona (P)] y a las que no presentaban aumento del ovario durante el mismo período. Resultados: A los tres meses, se detectó quiste ovárico en el 5,2%, 13,0% y 1,9% de las usuarias de Implanon®, Jadelle® y DIU, respectivamente. A los 6 meses de uso, la prevalencia fue del 7,2%, 8,0% y 2,1%, mientras que a los 12 meses los porcentajes fueron 26,7%, 14,6% y 1,2% en los tres grupos, respectivamente. Las concentraciones de E(-2) fueron significativamente más altas entre las usuarias con quiste ovárico que en las del grupo control. El intervalo hasta la desaparición del quiste ovárico fue similar en los tres grupos. Se registraron más casos de menorragia en usuarias de implantes que tenían quiste ovárico que en las que no presentaban aumento del tamaño del ovario. Conclusiones: La presencia de quiste ovárico o de aumento de los folículos ováricos durante el primer año de uso de implantes de Implanon® y Jadelle® es frecuente y transitoria y no se debe interpretar como un quiste ovárico patológico. No se requieren intervenciones médicas adicionales. (del autor) Language: English Keywords: BRAZIL | RESEARCH REPORT | EPIDEMIOLOGIC METHODS | WOMEN IN DEVELOPMENT | OVARIAN CYSTS | CONTRACEPTIVE IMPLANTS | PELVIC EXAM | ULTRASONICS | ESTRADIOL | PROGESTERONE | PREVALENCE | FOLLICLE STIMULATING HORMONE | MENORRHAGIA | CONTRACEPTIVE SAFETY | South America, Eastern | South America | Latin America | Americas | Developing Countries | Research Methodology | Economic Development | Economic Factors | Diseases | Contraceptive Methods | Contraception | Family Planning | |