1.  Title: Combined oral contraceptive pills for treatment of acne. Author: Arowojolu AO; Gallo MF; Lopez LM; Grimes DA; Garner SE Source: Cochrane Database of Systematic Reviews. 2009;(3):CD004425. Abstract: BACKGROUND: Acne is a common skin disorder among women. Although no uniform approach to the management of acne exists, combination oral contraceptives (COCs), which contain an estrogen and a progestin, often are prescribed for women. OBJECTIVES: To determine the effectiveness of combined oral contraceptives (COCs) for the treatment of facial acne compared to placebo or other active therapies. SEARCH STRATEGY: We searched for randomized controlled trials of COCs and acne in the computerized databases of the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, POPLINE, and LILACS. We also searched for clinical trials in ClinicalTrials.gov and the International Clinical Trials Registry Platform (ICTRP). We wrote to authors of identified trials to seek any unpublished or published trials that we might have missed. SELECTION CRITERIA: All randomized controlled trials reported in any language that compared the effectiveness of a COC containing an estrogen and a progestin to placeboor another active therapy for acne in women were eligible. DATA COLLECTION AND ANALYSIS: We extracted data on total and specific (i.e., open or closed comedones, papules, pustules and nodules) facial lesion counts; acne severity grades; global assessments by the clinician or the participant and discontinuation due to adverse events. Data were entered and analyzed in RevMan. MAIN RESULTS: The search yielded 25 trials: 7 placebo-controlled trials made 4 different comparisons, 17 trials made 13 comparisons between 2 different COC regimens, and 1 additional trial compared a COC to an antibiotic. COCs reduced acne lesion counts, severity grades and self-assessed acne compared to placebo. Differences in the comparative effectiveness of COCs containing varying progestin types and dosages, though, were less clear. COCs that contained chlormadinone acetate or cyproterone acetate improved acne better than levonorgestrel, although this apparent advantage was based on limited data. A COC with cyproterone acetate might result in better acne outcomes than one with desogestrel; however, the three studies comparing these COCs produced conflicting results. Likewise, levonorgestrel showed a slight improvement over desogestrel in acne outcomes in one trial, but a second trial found the COC groups were similar. AUTHORS' CONCLUSIONS: The four COCs evaluated in placebo-controlled trials are effective in reducing inflammatory and non-inflammatory facial acne lesions. Few important differences were found between COC types in their effectiveness for treating acne. How COCs compare to alternative acne treatments is unknown since limited data were available regarding this question. Language: English Keywords: GLOBAL | LITERATURE REVIEW | CLINICAL TRIALS | COMPARATIVE STUDIES | WOMEN | ACNE | TREATMENT | ORAL CONTRACEPTIVES, COMBINED | ADMINISTRATION AND DOSAGE | ANTIBIOTICS | HORMONES | Clinical Research | Research Methodology | Studies | Demographic Factors | Population | Dermatitis | Diseases | Medical Procedures | Medicine | Health Services | Delivery of Health Care | Health | Oral Contraceptives | Contraceptive Methods | Contraception | Family Planning | Drugs | Endocrine System | Physiology | Biology Document Number: 341912 |
| 2. Title: Suggestions for effective contraception in isotretinoin therapy [letter] Author: Kanelleas AI; Thornton S; Berth-Jones J Source: British Journal of Clinical Pharmacology. 2009 Jan;67(1):137-8. Abstract: This letter to the editor argues that parenteral progestogen-only contraceptives are adopted as a standard approach to contraception for female patients considered for isotretinoin therapy, an effective drug for acne. It touches on the issues of isotretinoin, pregnancy, birth defects, and abortion. Language: English Keywords: UNITED KINGDOM | CRITIQUE | CLINICAL RESEARCH | PREGNANT WOMEN | INFANT | CHROMOSOME ABNORMALITIES | CONGENITAL ABNORMALITIES | PREVALENCE | ACNE | DRUGS | TREATMENT | CONTRACEPTIVE SAFETY | INJECTABLES | OSTEOPOROSIS | TIME FACTORS | Developed Countries | Europe, Western | Europe | Research Methodology | Population Characteristics | Demographic Factors | Population | Youth | Age Factors | Neonatal Diseases and Abnormalities | Diseases | Measurement | Dermatitis | Medical Procedures | Medicine | Health Services | Delivery of Health Care | Health | Safety | Public Health | Contraceptive Methods | Contraception | Family Planning | Skeletal Effects | Physiology | Biology | Population Dynamics Document Number: 341136 |
| 3. Title: A randomized controlled trial of a low-dose combined oral contraceptive containing 3 mg drospirenone plus 20 microg ethinylestradiol in the treatment of acne vulgaris: lesion counts, investigator ratings and subject self-assessment. Author: Maloney JM; Dietze P Jr; Watson D; Niknian M; Lee-Rugh S; Sampson-Landers C; Korner P Source: Journal of Drugs In Dermatology. 2009 Sep;8(9):837-44. Abstract: OBJECTIVE: To assess the efficacy of a combined oral contraceptive (COC) containing 3 mg drospirenone (drsp) plus 20 microg ethinylestradiol (EE) administered in 24 days of active treatment followed by a four-day hormone-free interval (24/4 regimen) compared with placebo for the treatment of moderate acne vulgaris. METHODS: Healthy females (14-45 years old) with moderate facial acne were randomized to 3 mg drsp/20 microg EE 24/4 (n = 270) or placebo (n = 268) for six cycles. The secondary efficacy variables measured included change from baseline to endpoint (cycle 6) in individual lesion count for nodules, papules, pustules, open and closed comedones. RESULTS: There were significantly greater reductions in individual lesion counts from baseline to endpoint in the 3 mg drsp/20 microg EE group than in the placebo group (P < 0.05 from parametric model). CONCLUSION: The 3 mg drsp/20 microg EE COC administered in a 24/4 regimen significantly reduced acne lesions. Language: English Keywords: UNITED STATES OF AMERICA | RESEARCH REPORT | CONTROL GROUPS | CLIENTS | WOMEN | ORAL CONTRACEPTIVES, COMBINED | LOW-DOSE PROGESTINS | ETHINYL ESTRADIOL | ACNE | TREATMENT | DERMATOLOGICAL EFFECTS | Developed Countries | North America | Americas | Research Methodology | Program Activities | Programs | Organization and Administration | Demographic Factors | Population | Oral Contraceptives | Contraceptive Methods | Contraception | Family Planning | Contraceptive Agents, Progestin | Contraceptive Agents, Female | Contraceptive Agents | Contraceptive Agents, Estrogen | Dermatitis | Diseases | Medical Procedures | Medicine | Health Services | Delivery of Health Care | Health | Physiology | Biology Document Number: 342779 |
| 4. Peer Reviewed Title: Efficacy of a combined oral contraceptive containing 0.030 mg ethinylestradiol/2 mg dienogest for the treatment of papulopustular acne in comparison with placebo and 0.035 mg ethinylestradiol/2 mg cyproterone acetate. Author: Palombo-Kinne E; Schellschmidt I; Schumacher U; Graser T Source: Contraception. 2009 Apr;79(4):282-9. Abstract: BACKGROUND: Acne is a multifactorial disease characterized by androgenic stimulation of sebaceous glands. Therefore, combined oral contraceptives (COCs) containing anti-androgenic progestogens are suitable candidates for acne treatment. This study aimed to show that a COC containing the anti-androgen dienogest (DNG) is superior to placebo and not inferior to a COC containing the potent anti-androgen cyproterone acetate (CPA) in improving mild to moderate acne. STUDY DESIGN: Healthy women between 16 and 45 years old with mild to moderate facial acne were randomly assigned to receive ethinylestradiol (EE)/DNG (n=525), EE/CPA (n=537) or placebo (n=264) for six cycles in a multinational, multicenter, three-arm, double-blind and randomized trial. The primary efficacy variables were the percentages of change (from baseline to cycle 6) in inflammatory and total lesion count and the percentage of patients with acne improvement according to the Investigator Global Assessment. RESULTS: All primary analyses proved that EE/DNG was superior to placebo and non-inferior to EE/CPA (p<.05). For inflammatory lesions, the reduction (+/-SD) rates were -65.6+/-29.9% for EE/DNG, -64.6+/-31.2% for EE/CPA and -49.4+/-41.0% for placebo. For total lesions, the reduction rates were -54.7+/-26.3% for EE/DNG, -53.6+/-27.5% for EE/CPA and -39.4+/-33.6% for placebo. The percentages of patients with improvement of facial acne were 91.9% for EE/DNG, 90.2% for EE/CPA and 76.2% for placebo. CONCLUSION: EE/DNG was superior to placebo, in spite of the prominent placebo effects, and as effective as EE/CPA in the treatment of mild to moderate acne, thus proving a valid option for the treatment of acne in women seeking oral contraception. Language: English Keywords: GERMANY | RESEARCH REPORT | CLINICAL TRIALS | WOMEN | ACNE | ORAL CONTRACEPTIVES | ETHINYL ESTRADIOL | TREATMENT | Europe, Central | Europe | Developed Countries | Clinical Research | Research Methodology | Demographic Factors | Population | Dermatitis | Diseases | Contraceptive Methods | Contraception | Family Planning | Contraceptive Agents, Estrogen | Contraceptive Agents, Female | Contraceptive Agents | Medical Procedures | Medicine | Health Services | Delivery of Health Care | Health Document Number: 330559 |
| 5. Peer Reviewed Title: Efficacy of an oral contraceptive containing EE 0.03 mg and CMA 2 mg (Belara) in moderate acne resolution: a randomized, double-blind, placebo-controlled Phase III trial. Author: Plewig G; Cunliffe WJ; Binder N; Hoschen K Source: Contraception. 2009 Jul;80(1):25-33. Abstract: BACKGROUND: The study was conducted to assess the effects of the monophasic combined oral contraceptive containing ethinyl estradiol (EE) 0.03 mg and chlormadinone acetate (CMA) 2 mg (EE/CMA) on papulopustular acne of the face, decollete (low neck) and back; on moderate comedonal acne of the face; and on seborrhea, alopecia and hirsutism. STUDY DESIGN: Three hundred seventy-seven women were randomized (2:1) to receive EE/CMA (n=251) or placebo (n=126) for six medication cycles. Due to the placebo-controlled, double-blind design of the trial, condoms were supplied for contraception. The primary efficacy end point was defined as a reduction of at least 50% in the number of papules and/or pustules of the face from admission to Medication Cycle 6. RESULTS: In total, 64.1% (161/251) of subjects treated with EE/CMA responded compared with 43.7% (55/126) of those taking placebo (p=.0001). The median reduction in papules/pustules on the face at Cycle 6 compared with admission was 63.6% (EE/CMA) compared with 45.3% (placebo group). For comedonal lesions of the face, the reduction in lesion numbers was 54.8% (EE/CMA) compared with 32.4% (placebo). Moderate papulopustular acne of the decollete decreased by 92.9% (EE/CMA) vs. 50% (placebo group) and of the back by 86.0% and 58.3%, respectively. For these skin conditions, the p values for the relative difference between groups vs. baseline were <.05 at Cycles 3 and 6, in favor of EE/CMA. As part of a self-assessment rating, at least 70.5% (EE/CMA) vs. 41.3% (placebo) reported an at least satisfactory improvement of their moderate acne. Even 39.8% of women taking EE/CMA reported an "excellent improvement" or "complete resolution" of moderate acne compared with 12.7% taking placebo. CONCLUSION: In addition to its contraceptive efficacy described elsewhere, EE/CMA is an effective treatment for moderate papulopustular acne and other androgen-related skin disorders. Language: English Keywords: UNITED KINGDOM | RESEARCH REPORT | RANDOMIZED RESPONSE TECHNIC | WOMEN | ORAL CONTRACEPTIVES, COMBINED | ETHINYL ESTRADIOL | ACNE | HIRSUTISM | TREATMENT | PROGRAM EFFECTIVENESS | Developed Countries | Europe, Western | Europe | Questionnaire Design | Survey Methodology | Surveys | Sampling Studies | Studies | Research Methodology | Demographic Factors | Population | Oral Contraceptives | Contraceptive Methods | Contraception | Family Planning | Contraceptive Agents, Estrogen | Contraceptive Agents, Female | Contraceptive Agents | Dermatitis | Diseases | Signs and Symptoms | Medical Procedures | Medicine | Health Services | Delivery of Health Care | Health | Program Evaluation | Programs | Organization and Administration Document Number: 341585 |
| 6. Title: [Oral contraception - dosis and way of administration] Hormonale Kontrazeption - Dosierung und Verabreichungsformen. Author: Thaler C; Kuhl H; Mueck A; Birkhauser M; Braendle W; Neulen J; Keller PJ; Kiesel L Source: therapeutische Umschau. Revue therapeutique. 2009 Feb;66(2):93-9. Abstract: Since the correlation between the amount of Ethinylestradiol (EE) and the thromboembolic risk has been recognized, the development of new oral contraceptives (OC) has been characterized by a constant lowering of the EE dosage. The consecutive decrease of ovulation inhibition has been compensated by the introduction of potent progestagens. Therefore, the contraceptive safety has been maintained in presence of less side-effects. The effect of ultra-low-dose OC on acne and seborrhea remains beneficial. The effect of ultra-low-dose OC on bone is contradictory. Because there are fundamental differences between Estradiol and EE, the thromboembolic risk is not decreased by the parenteral administration of EE. In users of the contraceptive patch, it is even increased. EE is not bound at SHBG. Because of its Ethinyl group, the inactivation of EE occurs slowly. Therefore, EE reaches the liver in a low but constant concentration where it modifies many estrogen-dependent hepatic parameters significantly. One of these is hemostasis. It is generally accepted that such changes are responsable for the increased thromboembolic risk of the contraceptive patch and vaginalring. A reduction of the homone-free interval of the pill to 5 or 4 days results in a complete suppression of the ovarian function, a reliable ovulation inhibition and an increase of the contraceptive efficacy in spite of a reduction of the EE dosage to 20 mug or 15 mug. Language: German Keywords: RESEARCH REPORT | CONTRACEPTIVE SAFETY | ORAL CONTRACEPTIVES, LOW-DOSE | ACNE | ADMINISTRATION AND DOSAGE | Safety | Public Health | Health | Oral Contraceptives | Contraceptive Methods | Contraception | Family Planning | Dermatitis | Diseases | Drugs | Treatment | Medical Procedures | Medicine | Health Services | Delivery of Health Care Document Number: 329573 |
| 7. Title: Hormonal therapy for acne. Author: George R; Clarke S; Thiboutot D Source: Seminars In Cutaneous Medicine and Surgery. 2008 Sep;27(3):188-96. Abstract: Acne affects more than 40 million people, of which more than half are women older than 25 years of age. These women frequently fail traditional therapy and have high relapse rates even after isotretinoin. Recent advances in research have helped to delineate the important role hormones play in the pathogenesis of acne. Androgens such as dihydrotestosterone and testosterone, the adrenal precursor dehydroepiandrosterone sulfate, estrogens, growth hormone, and insulin-like growth factors may all contribute to the development of acne. Hormonal therapy remains an important part of the arsenal of acne treatments available to the clinician. Women dealing with acne, even those without increased serum androgens, may benefit from hormonal treatments. The mainstays of hormonal therapy include oral contraceptives and antiandrogens such as spironolactone, cyproterone acetate, or flutamide. In this article, we discuss the effects of hormones on the pathogenesis of acne, evaluation of women with suspected endocrine abnormalities, and the myriad of treatment options available. Language: English Keywords: UNITED STATES OF AMERICA | RESEARCH REPORT | WOMEN | ACNE | TREATMENT | ORAL CONTRACEPTIVES | Developed Countries | North America | Americas | Demographic Factors | Population | Dermatitis | Diseases | Medical Procedures | Medicine | Health Services | Delivery of Health Care | Health | Contraceptive Methods | Contraception | Family Planning Document Number: 329648 |
| 8. Title: Non-contraceptive benefits of oral contraceptives. Author: Huber JC; Bentz EK; Ott J; Tempfer CB Source: Expert Opinion On Pharmacotherapy. 2008 Sep;9(13):2317-25. Abstract: BACKGROUND: There is increasing awareness of the opportunity that many contraceptive interventions may provide for additional health benefits. However, treatment of medical problems with oral contraceptives (OCs) is often an 'off-label' practice. OBJECTIVE: The aim of this review is to summarize available data on non-contraceptive benefits of OCs. METHODS: Review of the literature. RESULTS: OCs have been shown to reduce the risk of ovarian, endometrial, and colorectal cancer. It has been suggested that OCs may be used in treatment of endometriosis, menorrhagia, and uterine leiomyomas. Pelvic inflammatory disease, dysmenorrhea, premenstrual syndrome, and acne have been shown to improve under OCs. CONCLUSION: OCs are important for global and female health. Besides contraception, non-contraceptive effects of OCs are evidence based, well established, and commonly used in clinical practice. Language: English Keywords: GLOBAL | RESEARCH REPORT | ENDOMETRIOSIS | ACNE | ENDOMETRIAL CANCER | MENSTRUATION DISORDERS | OVARIAN CANCER | PELVIC INFECTIONS | PREMENSTRUAL TENSION | ORAL CONTRACEPTIVES | Diseases | Dermatitis | Cancer | Neoplasms | Infections | Contraceptive Methods | Contraception | Family Planning Document Number: 328808 |
| 9. Title: Effects of an oral contraceptive containing chlormadinone and ethinylestradiol on acne-prone skin of women of different age groups: an open-label, single-centre, phase IV study. Author: Kerscher M; Reuther T; Bayrhammer J; Schramm G Source: Clinical Drug Investigation. 2008;28(11):703-11. Abstract: BACKGROUND AND OBJECTIVE: Acne-prone skin, a common skin condition not only in adolescents but also in adults, can significantly influence the affected individual's quality of life. The aim of this open-label, prospective, single-centre, phase IV study was to investigate the effects of an oral contraceptive containing chlormadinone 2 mg and ethinylestradiol 0.03 mg (Belara) on the physiology of acne-prone facial skin in healthy women aged 18-37 years. METHODS: Forty-four Caucasian women requesting hormonal contraception divided into two age groups (group A: 18-27 years; group B: 28-37 years) were treated with chlormadinone/ethinylestradiol for six menstrual cycles. During each treatment phase, each subject took one tablet per day for 21 consecutive days, followed by a 7-day pill-free interval. Medication was commenced on the first day of menses. Changes in skin parameters were evaluated in terms of the clinical sum score (the primary outcome variable, calculated from the number of comedones, the number of papules/papulopustules, and the sebum secretion state), the evaluation of the pore size using standardized photography, and a range of biophysical in vivo measurements, assessed at baseline, after 12 weeks and after 24 weeks. RESULTS: In both age groups, facial skin condition as quantified by the clinical sum score improved significantly after three and six treatment cycles, with reduced numbers of acne lesions (comedones and papules/papulopustules) and a reduction in seborrhoea. Moreover, there was a statistically significant decrease in pore size. Biophysical evaluations confirmed favourable effects of the medication on diverse skin parameters. Skin surface pH remained within the normal physiological range and there was an improvement in epidermal barrier function (as manifested by decreased transepidermal water loss from the skin of the forehead). Stratum corneum hydration increased in both age groups and the lipid content of the skin surface on the forehead decreased significantly after three treatment cycles in subjects aged 28-37 years. Ultrasound measurements verified that there was no retention of water within the dermis. There was no difference between the two age groups. CONCLUSION: For the first time, improvements in several facial skin parameters during treatment with a combined oral contraceptive (chlormadinone/ethinyl-estradiol) were quantified by biophysical methods and a clinical sum score. The highly statistically significant improvements in clinical findings and various biophysical skin parameters observed in this study suggest that the antiandrogenic oral contraceptive chlormadinone/ethinylestradiol may be a major therapy option in women with acne-prone skin who request hormonal contraception. Language: English Keywords: GERMANY | RESEARCH REPORT | CLINICAL TRIALS | WOMEN | WHITES | ETHINYL ESTRADIOL | ORAL CONTRACEPTIVES, COMBINED | ACNE | DERMATOLOGICAL EFFECTS | TREATMENT | AGE FACTORS | Europe, Central | Europe | Developed Countries | Clinical Research | Research Methodology | Demographic Factors | Population | Ethnic Groups | Cultural Background | Population Characteristics | Contraceptive Agents, Estrogen | Contraceptive Agents, Female | Contraceptive Agents | Contraception | Family Planning | Oral Contraceptives | Contraceptive Methods | Dermatitis | Diseases | Physiology | Biology | Medical Procedures | Medicine | Health Services | Delivery of Health Care | Health Document Number: 329816 |
| 10. Title: [Summary of the practice guideline 'Acne' (second revision) from the Dutch College of General Practitioners] Samenvatting van de standaard 'Acne' (tweede herziening) van her Nederlands Author: Kertzman MG; Smeets JG; Boukes FS; Goudswaard AN Source: Nederlands Tijdschrift Voor Geneeskunde. 2008 May 31;152(22):1271-5. Abstract: The 1999 practice guideline 'Acne vulgaris' from the Dutch College of General Practitioners has been revised. Benzoyl peroxide and local retinoids are first choice in local treatment of acne. When treatment with oral antibiotics is indicated, doxycycline is first choice. Use of minocycline is not recommended in general practice. It is recommended that both local and oral antibiotics are always combined with local benzoyl peroxide or a local retinoid. Oral contraceptives are only recommended in women with acne who also desire contraception. Use of oral contraceptives containing cyproterone acetate is no longer recommended in women with acne, because they are not more effective than other oral contraceptives. Treatment with oral isotretinoin may be given by the general practitioner, as long as the treatment guidelines are carefully followed. Language: Dutch Keywords: NETHERLANDS | RESEARCH REPORT | STANDARDS | ACNE | TREATMENT | SAFETY | ANTIBIOTICS | ORAL CONTRACEPTIVES | CONTRACEPTIVE USE-EFFECTIVENESS | Developed Countries | Europe, Western | Europe | Research Methodology | Dermatitis | Diseases | Medical Procedures | Medicine | Health Services | Delivery of Health Care | Health | Public Health | Drugs | Contraceptive Methods | Contraception | Family Planning | Contraceptive Effectiveness Document Number: 328922 |
| 11. Peer Reviewed Title: Advances in the treatment of acne. Author: Kimball AB Source: Journal of Reproductive Medicine. 2008 Sep;53(9 Suppl):742-52. Abstract: Acne vulgaris affects most people at some time in their life. This common condition can have devastating effects on a person's quality of life and may leave permanent scars. Treatment options, which are designed to disrupt one or more of the pathogenic features that characterize acne, include topical therapies (e.g., antibiotics, retinoids, benzoyl peroxide and combination products), systemic treatments (e.g., oral antibiotics, hormonal therapies and oral retinoids, which are indicated for severe recalcitrant nodulocystic acne), and, to a lesser extent, light-based and physical treatments. Combination oral contraceptives (COCs) represent one type of hormonal treatment. Their mode of action is to reduce the availability of free testosterone, which stimulates the sebaceous glands to produce sebum. Most COCs used in the United States contain progestins derived from 19-nortestosterone, giving them at least some degree of androgenic activity. Of the 3 COCs with an FDA indication for the treatment of moderate acne, only YAZ contains drospirenone, a progestin that combines no androgenic activity with antiandrogenic activity. This drospirenone-containing COC has been shown to be effective in reducing both inflammatory and noninflammatory acne lesions. Language: English Keywords: UNITED STATES OF AMERICA | LITERATURE REVIEW | ACNE | DIET | NUTRITION | PREVALENCE | ORAL CONTRACEPTIVES | ORAL CONTRACEPTIVES, COMBINED | TREATMENT | Developed Countries | North America | Americas | Dermatitis | Diseases | Health | Measurement | Research Methodology | Contraceptive Methods | Contraception | Family Planning | Medical Procedures | Medicine | Health Services | Delivery of Health Care Document Number: 329797 |
| 12. Title: Efficacy and tolerance of acne treatment using both spironolactone and a combined contraceptive containing drospirenone. Author: Krunic A; Ciurea A; Scheman A Source: Journal of the American Academy of Dermatology. 2008 Jan;58(1):60-62. Abstract: The use of either oral contraceptives or antiandrogens has been shown to be helpful in the treatment of women with acne. We investigated the safety and efficacy of acne treatment using both spironolactone and a combined contraceptive containing drospirenone. Twenty-seven women with either severe papular or nodulocystic facial acne were treated with a combined oral contraceptive containing 30 microg ethinyl estradiol and 3 mg drospirenone (EE/DRSP; Yasmin) and spironolactone (SL) 100 mg taken daily. A serum potassium level was obtained before initiation of therapy. Between 4 and 6 weeks after the start of both medications, a second serum potassium level was obtained. Side effects were recorded. Results: No significant elevation of serum potassium was found in any of the subjects nor were there any reported additional side effects significant enough to discontinue treatment. At follow up, 85% of subjects were entirely clear of acne lesions or had excellent improvement, 7.4% were mildly improved, and7.4% were not improved. This was a small prospective study. The combination of EE/DRSP and SL 100 mg daily appears to have efficacy and is well tolerated in the treatment of severe papular and nodulocystic acne in women. (author's) Language: English Keywords: UNITED STATES OF AMERICA | RESEARCH REPORT | PROSPECTIVE STUDIES | WOMEN | ACNE | TREATMENT | DRUGS | ORAL CONTRACEPTIVES | CONTRACEPTIVE USE-EFFECTIVENESS | CONTRACEPTIVE SAFETY | Developed Countries | North America | Americas | Studies | Research Methodology | Demographic Factors | Population | Dermatitis | Diseases | Medical Procedures | Medicine | Health Services | Delivery of Health Care | Health | Contraceptive Methods | Contraception | Family Planning | Contraceptive Effectiveness | Safety | Public Health Document Number: 323636 |
| 13. Title: A combined oral contraceptive containing 3-mg drospirenone/ 20-microg ethinyl estradiol in the treatment of acne vulgaris: a randomized, double-blind, placebo-controlled study evaluating lesion counts and participant self-assessment. Author: Lucky AW; Koltun W; Thiboutot D; Niknian M; Sampson-Landers C; Korner P Source: Cutis; Cutaneous Medicine For the Practitioner. 2008 Aug;82(2):143-50. Abstract: This study compared the efficacy of a low-dose combined oral contraceptive (COC) containing 3-mg drospirenone and 20-microg ethinyl estradiol (3-mg DRSP/20-microg EE) administered in a 24-day active pill/4-day inert pill (24/4) regimen and placebo in women with moderate acne vulgaris during 6 treatment cycles. A total of 534 participants were randomized and dispensed study medication (n = 266 [3-mg DRSP/20-microg EE 24/4 regimen COC group]; n = 268 [placebo group]). Women of reproductive age were eligible for inclusion in the study. Treatment with the 3-mg DRSP/20-microg EE 24/4 regimen COC was associated with a greater reduction from baseline to end point in individual lesion counts (papules, pustules, open and closed comedones) compared with placebo. The mean nodule count remained essentially constant throughout the study and was low in both treatment groups. There was a significantly higher probability that a participant had an improved assessment on the investigator's overall improvement rating scale (odds ratio [OR], 4.02; 95% CI [confidence interval], 2.29-7.31; P < .0001) and participant's overall self-assessment rating scale (OR, 2.82; 95% CI, 1.60-5.13; P = .0005) in the 3-mg DRSP/20-microg EE 24/4 regimen COC group than in the placebo group. The COC 3-mg DRSP/20-microg EE 24/4 regimen is a suitable option for women with moderate acne vulgaris who require contraception. Language: English Keywords: UNITED STATES OF AMERICA | RESEARCH REPORT | CLINICAL TRIALS | DOUBLE-BLIND STUDIES | WOMEN | ETHINYL ESTRADIOL | ORAL CONTRACEPTIVES, COMBINED | ACNE | CONTRACEPTIVE AGENTS, SIDE EFFECTS | SELF-PERCEPTION | ADMINISTRATION AND DOSAGE | TREATMENT | USFDA | Developed Countries | North America | Americas | Clinical Research | Research Methodology | Studies | Demographic Factors | Population | Contraceptive Agents, Estrogen | Contraceptive Agents, Female | Contraceptive Agents | Contraception | Family Planning | Oral Contraceptives | Contraceptive Methods | Dermatitis | Diseases | Perception | Psychological Factors | Behavior | Drugs | Medical Procedures | Medicine | Health Services | Delivery of Health Care | Health | USPHS | Government Agencies | Organizations | Political Factors | Sociocultural Factors Document Number: 328895 |
| 14. Peer Reviewed Title: Non-contraceptive health benefits of oral contraceptives. Author: Maia H Jr; Casoy J Source: European Journal of Contraception and Reproductive Health Care. 2008 Mar;13(1):17-24. Abstract: The use of combined oral contraceptives (COCs) is associated with a reduced risk of developing endometriosis, myomas, and endometrial and ovarian carcinoma. The mechanisms involved are multiple; next to ovulation suppression, a reduction in inflammation in the genital tract is involved. This is accomplished through inhibition of the endometrial expression of enzymes related to the biosynthesis of prostaglandin and oestrogen, particularly cyclooxygenase type II (Cox-2) and aromatase. The blockade of these enzymatic systems by COCs explains the beneficial effects of these compounds in treating the symptoms, and halting the progression of myomas, endometriosis and adenomyosis, all of which are characterized by increased inflammation. Inhibition of aromatase and Cox-2 expression in the endometrium by COCs may explain their efficacy in controlling the pain and excessive uterine bleeding caused by these pathologies. The reduction of inflammation in the endometrium may also be the mechanism behind the lower incidence of endometrial carcinoma in COC users. The blockade of ovulation and ovarian steroidogenesis, on the other hand, may explain the lesser incidence of ovarian cancer and the improvement of acne in users. In conclusion, inflammation appears to play a pivotal role in the development of various benign and malignant gynecological diseases. COCs reduce inflammation in the female genital tract by blocking enzymes such as Cox-2 and aromatase. (author's) Language: English Keywords: BRAZIL | LITERATURE REVIEW | WOMEN | ORAL CONTRACEPTIVES | ENDOMETRIOSIS | MENORRHAGIA | ENDOMETRIAL CANCER | OVARIAN CANCER | ACNE | MENOPAUSE | South America, Eastern | South America | Latin America | Americas | Developing Countries | Demographic Factors | Population | Contraceptive Methods | Contraception | Family Planning | Diseases | Menstruation Disorders | Cancer | Neoplasms | Dermatitis | Reproduction Document Number: 324655 |
| 15. Peer Reviewed Title: Treatment of acne using a 3-milligram drospirenone/20-microgram ethinyl estradiol oral contraceptive administered in a 24/4 regimen: a randomized controlled trial. Author: Maloney JM; Dietze P Jr; Watson D; Niknian M; Lee-Rugh S Source: Obstetrics and Gynecology. 2008 Oct;112(4):773-81. Abstract: OBJECTIVE: To assess the efficacy of the combined oral contraceptive containing 3-mg drospirenone/20-microgram ethinyl estradiol (3-mg drospirenone/20-microgram ethinyl estradiol) administered as 24 consecutive days of active treatment after a 4-day hormone-free interval (24/4 regimen) compared with placebo for the treatment of moderate acne vulgaris. METHODS: Healthy females aged 14-45 years with moderate acne were randomized in this double-blind study to 3-mg drospirenone/20-microgram ethinyl estradiol (n=270) or placebo (n=268) for six cycles of 28 days. The primary outcome measures of acne lesion counts and Investigator Static Global Assessment scale ratings were assessed at baseline and during cycles 1, 3, and 6. RESULTS: The percentage reduction from baseline to endpoint for total lesions is 46.3% for 3-mg drospirenone/20-microgram ethinyl estradiol 24/4 combination oral contraceptive group and 30.6% for placebo group (P<.001). The likelihood of participants in the 3-mg drospirenone/20-microgram ethinyl estradiol 24/4 regimen group having "clear" or "almost clear" skin as rated by the investigators at endpoint was about threefold (odds ratio 3.13, 95% confidence interval 1.69-5.81; P=.001) greater than in the placebo group. The 3-mg drospirenone/20-microgram ethinyl estradiol 24/4 regimen was well tolerated. CONCLUSION: The low-dose combined oral contraceptive containing 3-mg drospirenone/20-microgram ethinyl estradiol administered in a 24/4 regimen significantly reduced acne lesion counts more effectively than placebo and demonstrated greater improvement in the Investigator Static Global Assessment rating of acne. The safety profile was consistent with low-dose combined oral contraceptive use. Language: English Keywords: CALIFORNIA | RESEARCH REPORT | CLINICAL RESEARCH | DOUBLE-BLIND STUDIES | EVALUATION INDEXES | WOMEN | ACNE | ETHINYL ESTRADIOL | ORAL CONTRACEPTIVES, COMBINED | ADMINISTRATION AND DOSAGE | HEALTH STATUS INDEXES | ORAL CONTRACEPTIVES, SIDE EFFECTS | United States of America | North America | Americas | Developed Countries | Research Methodology | Studies | Quantitative Evaluation | Evaluation | Demographic Factors | Population | Dermatitis | Diseases | Contraceptive Agents, Estrogen | Contraceptive Agents, Female | Contraceptive Agents | Contraception | Family Planning | Oral Contraceptives | Contraceptive Methods | Drugs | Treatment | Medical Procedures | Medicine | Health Services | Delivery of Health Care | Health | Contraceptive Safety | Safety | Public Health Document Number: 329095 |
| 16. Peer Reviewed Title: An oral contraceptive with 3 approved indications. Author: Mishell DR Jr Source: Journal of Reproductive Medicine. 2008 Sep;53(9 Suppl):717-9. Abstract: This introductory article provides a historical overview of COCs in addition to describing the contents of the journal issue which is to inform clinician about YAZ, a COC that is unique in several ways. YAZ is a low-dose COC that combines 3 mg of drospirenone with 20 microg of EE; its regimen consists of 24 days of active pills in a 28-day cycle. Language: English Keywords: UNITED STATES OF AMERICA | RESEARCH REPORT | ORAL CONTRACEPTIVES, COMBINED | ACNE | ORAL CONTRACEPTIVES, SIDE EFFECTS | CONTRACEPTIVE SAFETY | TREATMENT | Developed Countries | North America | Americas | Oral Contraceptives | Contraceptive Methods | Contraception | Family Planning | Dermatitis | Diseases | Safety | Public Health | Health | Medical Procedures | Medicine | Health Services | Delivery of Health Care Document Number: 329800 |
| 17. Peer Reviewed Title: YAZ and the novel progestin drospirenone. Author: Mishell DR Jr Source: Journal of Reproductive Medicine. 2008 Sep;53(9 Suppl):721-8. Abstract: Drospirenone is a novel progestin that is structurally related to 17 alpha-spirolactone and has antimineralocorticoid and antiandrogenic activity. A 3-mg dose of drospirenone was first used in combination with ethinyl estradiol (EE) 30 microg in a combination oral contraceptive (COC) that is administered for 21 days, followed by a 7-day hormone-free interval (HFI) (drospirenone/30EE, or Yasmin). The 21/7 regimen is considered to be the standard regimen for COC delivery. A formulation with the metabolic benefit of COCs containing a lower estrogen dose has been developed combining drospirenone 3 mg with EE 20 microg and using a regimen of 24 days of active pills, followed by a 4-day HFI (drospirenone/20EE-24/4), or YAZ (Bayer HealthCare Pharmaceuticals Inc., Wayne, New Jersey). Since drospirenone has a half-life of > 30 hours, its activity extends for a prolonged time into the shortened HFI. This new COC has been shown to provide effective contraception and to have a good safety profile. Two large noninterventional studies have recently evaluated the safety of drospirenone/30EE in 2 areas of special interest: hyperkalemia and thromboembolic events. Use of a drospirenone-containing COC was not associated with an increased risk of either type of disorder in comparison with COCs containing other progestins. Drospirenone/20EE-24/4 provides a low dose of EE in combination with drospirenone in an effective and safe COC that is administered using a regimen with a shortened HFI. Drospirenone/20EE-24/4 is the only COC with 3 indications: contraception and the treatment of premenstrual dysphoric disorder in women who wish to use a COC for birth control, and the treatment of moderate acne in women who are at least 14-years-old, have achieved menarche and wish to use a COC for birth control. Language: English Keywords: UNITED STATES OF AMERICA | LITERATURE REVIEW | CLINICAL RESEARCH | WOMEN | LOW-DOSE PROGESTINS | ORAL CONTRACEPTIVES, COMBINED | ORAL CONTRACEPTIVES, LOW-DOSE | ACNE | ORAL CONTRACEPTIVES, SIDE EFFECTS | TIME FACTORS | METABOLIC EFFECTS | CONTRACEPTIVE MODE OF ACTION | PREMENSTRUAL TENSION | CONTRACEPTIVE SAFETY | CONTRACEPTIVE EFFECTIVENESS | Developed Countries | North America | Americas | Research Methodology | Demographic Factors | Population | Contraceptive Agents, Progestin | Contraceptive Agents, Female | Contraceptive Agents | Contraception | Family Planning | Oral Contraceptives | Contraceptive Methods | Dermatitis | Diseases | Safety | Public Health | Health | Population Dynamics | Physiology | Biology | Menstruation Disorders Document Number: 329799 |
| 18. Title: Adolescent female acne: etiology and management. Author: Olutunmbi Y; Paley K; English JC 3rd Source: Journal of Pediatric and Adolescent Gynecology. 2008 Aug;21(4):171-6. Abstract: Acne vulgaris, a multifactorial condition often conferring significant psychosocial morbidity, affects an estimated 40 million people in the United States. The majority of these individuals are adolescents and young adults. The pathophysiology of the condition is still not fully known, but it is believed to be related in part to excess sebum production, follicular hyperkeratinization, microbial colonization by P acnes, and inflammation. Prior to initiating treatment in a female patient, a hyperandrogenic state must be considered and ruled out through history, physical exam, and laboratory evaluation if necessary. Treatment options are vast and include hormonal therapy among others. Hormonal therapies have long been noted to reduce acne lesions and offer a valuable adjuvant to standard therapy. Hormonal agents are thought to improve acne by blocking the androgen receptor and/or decreasing circulating androgens which leads to decreased sebum production. Hormonal treatment options include spironolactone, other antiandrogens, and oral contraceptives. The use of these agents to effectively treat acne has been demonstrated in several randomized, placebo-controlled clinical trials. Optimal results are often achieved with combination therapy with the goal of targeting multiple pathogenic pathways in acne development. Language: English Keywords: UNITED STATES OF AMERICA | PENNSYLVANIA | RESEARCH REPORT | ADOLESCENTS, FEMALE | ACNE | MANAGEMENT | TREATMENT | ORAL CONTRACEPTIVES | Developed Countries | North America | Americas | Adolescents | Youth | Age Factors | Population Characteristics | Demographic Factors | Population | Dermatitis | Diseases | Organization and Administration | Medical Procedures | Medicine | Health Services | Delivery of Health Care | Health | Contraceptive Methods | Contraception | Family Planning Document Number: 328622 |
| 19. Peer Reviewed Title: YAZ in the treatment of premenstrual dysphoric disorder. Author: Rapkin AJ Source: Journal of Reproductive Medicine. 2008 Sep;53(9 Suppl):729-41. Abstract: Premenstrual disorders negatively affect millions of U.S. women. The premenstrual disorder at the most severe end of the spectrum is premenstrual dysphoric disorder (PMDD). The specific diagnostic criteria developed for PMDD and the availability of validated symptom diaries have allowed a more organized study of severe premenstrual disorders. The U.S Food and Drug Administration has now approved 4 agents for the treatment of PMDD: 3 antidepressants (i.e., selective serotonin reuptake inhibitors) and 1 low-dose combination oral contraceptive (COC) that contains the progestin drospirenone and is administered using a regimen of 24 days of active pills in a 28-day cycle (drospirenone/20EE-24/4). Drospirenone is unique among progestins used in COCs in that it has both antimineralocorticoid and antiandrogenic activities. Two pivotal studies have shown drospirenone/20EE-24/4 to be effective in treating the mood, physical and behavioral symptoms of PMDD and symptoms specifically associated with food, water retention and negative interpersonal relationships. Language: English Keywords: UNITED STATES OF AMERICA | LITERATURE REVIEW | ACNE | ORAL CONTRACEPTIVES, COMBINED | PREMENSTRUAL TENSION | SIGNS AND SYMPTOMS | TREATMENT | Developed Countries | North America | Americas | Dermatitis | Diseases | Oral Contraceptives | Contraceptive Methods | Contraception | Family Planning | Menstruation Disorders | Medical Procedures | Medicine | Health Services | Delivery of Health Care | Health Document Number: 329798 |
| 20. Peer Reviewed Title: Contraceptive efficacy and side effects of Implanon. Author: Gezginc K; Balci O; Karatayli R; Colakoglu MC Source: European Journal of Contraception and Reproductive Health Care. 2007 Dec;12(4):362-365. Abstract: The objective was to determine the efficacy and side effects of Implanon used for long-term contraception. Prospective study of 80 patients who used Implanon for longterm contraception between January 2004 and January 2006; side effects, efficacy and removals were recorded. Amenorrhoea, infrequent bleeding and frequent bleeding were reported by 33 (41.25%), 19 (23.75%) and 14 patients (17.5%), respectively. Non-menstrual side effects comprised breast tenderness in 15 patients (18.75%), acne in eight (10%), headache and dizziness in three (3.75%); depressive mood disorders, pelvic pain and loss of libido were mentioned each by two of the women (2.5%). During the study period, Implanon was removed from 20 participants. No problem was encountered during its placement or removal. Patients considering use of Implanon must be carefully selected and informed about its expected side effects before placement. (author's) Language: English Keywords: TURKEY | RESEARCH REPORT | CLINICAL RESEARCH | EPIDEMIOLOGIC METHODS | WOMEN IN DEVELOPMENT | CONTRACEPTIVE IMPLANTS | CONTRACEPTIVE EFFECTIVENESS | CONTRACEPTIVE AGENTS, SIDE EFFECTS | DIZZINESS | MENSTRUATION DISORDERS | ACNE | PREVALENCE | HEADACHE | DEPRESSION | PELVIS | Europe, Southeastern | Europe | Developing Countries | Research Methodology | Economic Development | Economic Factors | Contraceptive Methods | Contraception | Family Planning | Contraceptive Agents | Signs and Symptoms | Diseases | Dermatitis | Measurement | Mental Disorders | Anatomy | Biology Document Number: 313978 |
| 21. Title: Implanon: A new implantable contraceptive. Author: Newberry YG Source: Nursing for Women's Health. 2007 Dec;11(6):607-611. Abstract: In July 2006, six years after Norplant was removed from the U.S. market, a new contraceptive implant, Implanon, was approved by the Food and Drug Administration (FDA). Implanon is a single-rod progestin implant that is placed subdermally in the upper arm and is effective for up to three years. Its use has been studied in 17 countries, including the United States. Organon USA, the company marketing Implanon, has reported extensive experience with the drug in more than 30 countries, with approximately 2.5 million implants inserted since 1998. Implanon releases 68 mg of etonogesterel, a third-generation progestin desogestrel metabolite with less androgenic activity than levonorgesterel. The single matchstick-size (4 cm x 2 mm) rod comes preloaded in a disposable sterile applicator. The system uses a carrier polymer, ethylene vinyl acetate, which provides controlled release over three years. (excerpt) Language: English Keywords: UNITED STATES OF AMERICA | GLOBAL | SUMMARY REPORT | ADOLESCENTS, FEMALE | CONTRACEPTIVE IMPLANTS | CONTRACEPTIVE MODE OF ACTION | CONTRACEPTIVE EFFECTIVENESS | DRUG INTERACTIONS | CONTRAINDICATIONS | BLEEDING | ACNE | SIDE EFFECTS | CONTRACEPTIVE AGENTS, SIDE EFFECTS | COUNSELING | Developed Countries | North America | Americas | Adolescents | Youth | Age Factors | Population Characteristics | Demographic Factors | Population | Contraceptive Methods | Contraception | Family Planning | Drugs | Treatment | Medical Procedures | Medicine | Health Services | Delivery of Health Care | Health | Signs and Symptoms | Diseases | Dermatitis | Contraceptive Agents | Clinic Activities | Program Activities | Programs | Organization and Administration Document Number: 324047 |
| 22. Peer Reviewed Title: Noncontraceptive benefits of two combined oral contraceptives with antiandrogenic properties among adolescents. Author: Sabatini R; Orsini G; Cagiano R; Loverro G Source: Contraception. 2007 Nov;76(5):342-347. Abstract: The aim of this study was to assess the noncontraceptive benefits of two combined oral contraceptives, containing progestins with well-known antiandrogenic properties, in adolescent girls. In this prospective observational study, the effects of two formulations containing 30 mcg of ethinyl estradiol combined with 2 mg chlormadinone acetate or 3 mg drospirenone were compared. Six-month data were obtained from 156 sexually active adolescents requiring contraception. We investigated the advantages of these regimens on intermenstrual bleeding, dysmenorrhea, acne and hair and skin disorders. Furthermore, their effects on sexual interest, intercourse frequency and sexual satisfaction were evaluated. Both preparations provided effective contraception, good cycle control and beneficial effects on preexisting hair and skin disorders without effects on body weight. However, the best results were obtained with the formulation containing chlormadinone acetate, with the difference being statistically significant. Furthermore, the contraceptive adherence to teenager expectations and the counseling effectiveness enhancing compliance contribute to a high rate of continuation. (author's) Language: English Keywords: ITALY | GLOBAL | RESEARCH REPORT | PROSPECTIVE STUDIES | ADOLESCENTS, FEMALE | ORAL CONTRACEPTIVES, COMBINED | TREATMENT | MENSTRUATION DISORDERS | DYSMENORRHEA | DERMATOLOGICAL EFFECTS | ACNE | Europe, Southern | Europe | Developed Countries | Studies | Research Methodology | Adolescents | Youth | Age Factors | Population Characteristics | Demographic Factors | Population | Oral Contraceptives | Contraceptive Methods | Contraception | Family Planning | Medical Procedures | Medicine | Health Services | Delivery of Health Care | Health | Diseases | Physiology | Biology | Dermatitis Document Number: 321662 |
| 23. Peer Reviewed Title: Switching hormonal contraceptives to a chlormadinone acetate-containing oral contraceptive. The Contraceptive Switch Study. Author: Schramm G; Heckes B Source: Contraception. 2007 Aug;76(2):84-90. Abstract: This prospective observational noninterventional study aimed at collecting information on changes in cycle control, dysmenorrhea, androgen-related skin conditions and tolerability in a large cohort of women who switched their oral contraceptive (OC) to 2.0 mg chlormadinone acetate (CMA)/0.03 mg ethinylestradiol (EE) (Belara). In a total of 20,897 women who were enrolled in a four-cycle clinical evaluation at 1597 gynecological practices throughout Germany, there are 16,781 women who switched from another contraceptive. The most frequently mentioned complaint for switching contraceptive was seborrhea/acne (6933/16,781 women; 41.3%). This was followed by cycle irregularities (18.8%), headache (15.9%), breast tension (15.1%), amenorrhea (14.9%), spotting (12.8%) and dysmenorrhea (11.7%). After switching to CMA/EE treatment, these symptoms decreased substantially or even disappeared in a large number of women. The vast majority of study participants scored both tolerability and well-being on CMA/EE intake as 'very good' or 'good'. The results revealed that 13,508 women (80.5%) stated being more satisfied or even much more satisfied on CMA/EE intake compared to their previously used contraceptive; most of them had taken progestins of the nortestosterone type. CMA/EE produced beneficial effects on skin conditions and well-being in OC switchers who experienced dissatisfaction with their previous contraceptive regimen. The results of this observational study support that 2.0 mg CMA/0.03 mg EE is well tolerated, provides a reliable cycle stability and is very effective in diminishing dysmenorrhea and other cycle-related complaints. Women suffering from problems on hormonal contraception received benefit from switching to the progesterone derivative CMA-containing OC. (author's) Language: English Keywords: GERMANY | RESEARCH REPORT | PROSPECTIVE STUDIES | WOMEN | CHLORMADINONE ACETATE | ORAL CONTRACEPTIVES | ADMINISTRATION AND DOSAGE | CONTRACEPTIVE METHOD SWITCHING | SIGNS AND SYMPTOMS | MENSTRUAL CYCLE | DYSMENORRHEA | ACNE | Europe, Central | Europe | Developed Countries | Studies | Research Methodology | Demographic Factors | Population | Contraceptive Agents, Progestin | Contraceptive Agents, Female | Contraceptive Agents | Contraception | Family Planning | Contraceptive Methods | Drugs | Treatment | Medical Procedures | Medicine | Health Services | Delivery of Health Care | Health | Contraceptive Usage | Diseases | Menstruation | Reproduction | Menstruation Disorders | Dermatitis Document Number: 318906 |
| 24. Peer Reviewed Title: Treating acne with oral contraceptives: use of lower doses. Author: Huber J; Walch K Source: Contraception. 2006;73:23-29. Abstract: Oral contraceptives (OCs) have been shown to effectively treat acne. Clinical trials of various doses of ethinyl estradiol (EE) combined with progestins such as levonorgestrel, desogestrel, norgestimate, gestodene, cyproterone acetate and drospirenone in monophasic, triphasic and combiphasic formulations used to treat acne in women are reviewed here. Open-label and comparative studies beginning in the 1980s were the first to demonstrate objective and subjective reductions in the incidence of acne, severity of existing acne and seborrhea. Placebo-controlled trials have corroborated these findings with a trend toward effective acne treatment with declining doses of EE. Significant reductions in total, inflammatory and noninflammatory lesions compared with placebo have been demonstrated with an OC containing the low dose of 20 µg of EE. Collectively, these findings support the use of low-dose OCs for the treatment of acne. (author's) Language: English Keywords: AUSTRIA | LITERATURE REVIEW | CLINICAL RESEARCH | CLINICAL TRIALS | COMPARATIVE STUDIES | ADOLESCENTS, FEMALE | ACNE | ORAL CONTRACEPTIVES, SIDE EFFECTS | ETHINYL ESTRADIOL | LEVONORGESTREL | ORAL CONTRACEPTIVES, LOW-DOSE | Europe, Central | Europe | Developed Countries | Research Methodology | Studies | Adolescents | Youth | Age Factors | Population Characteristics | Demographic Factors | Population | Dermatitis | Diseases | Contraceptive Safety | Safety | Public Health | Health | Contraceptive Agents, Estrogen | Contraceptive Agents, Female | Contraceptive Agents | Contraception | Family Planning | Contraceptive Agents, Progestin | Oral Contraceptives | Contraceptive Methods Document Number: 293355 |
| 25. Peer Reviewed Title: The effect of a phasic oral contraceptive containing Desogestrel on seborrhea and acne. Author: Kränzlin HT; Nap MA Source: European Journal of Contraception and Reproductive Health Care. 2006 Mar;11(1):6-13. Abstract: Objective To investigate the effect of an oral contraceptive (Novial®) on facial seborrhea and moderate acne. Methods In this nonrandomized, group-comparative trial, women aged between 18 and 30 with seborrhea were enrolled. Women used either a phasic oral contraceptive containing ethinylestradiol (35/30/30µg and Desogestrel (50/100/150 µg (DSG- OC)) (n=177) or no hormonal treatment (control group; n=77) for four cycles. Results Overall, 161 subjects (90.9%) in the DSG-OC group and 73 subjects (94.4%) in the control group completed the study. In the DSG-OC group, the total score for sebum excretion decreased by 0.71 nL/cm(2) (95% CI 0.36- 1.05). In the control group, sebum excretion increased by 0.05 nL/cm(2) (- 0.55 to 0.46). The difference between groups (0.78 nL/cm(2) (0.19-1.36)) was statistically significant (P=0.010). The number of active follicles/cm(2) decreased by 0.86 (0.44-1.28) and 0.08 (-0.53 to 0.69), respectively (P=0.029). The difference in qualitative scores between the groups (0.93 (0.08-1.78)) was statistically significant (P=0.032). Overall, 19.3% of the subjects reported an EA (18.1% in the DSG-OC group, 22.1% in the control group). Conclusion Novial® effectively reduces seborrhea after only four cycles of treatment and may be suitable oral contraceptive for women wishing to improve their facial skin condition. (author's) Language: English Keywords: NETHERLANDS | RESEARCH REPORT | CLINICAL RESEARCH | WOMEN | ORAL CONTRACEPTIVES | DERMATITIS | ACNE | ETHINYL ESTRADIOL | ORAL CONTRACEPTIVES, SIDE EFFECTS | DESOGESTREL | TREATMENT | ORAL CONTRACEPTIVES, LOW-DOSE | Europe, Western | Europe | Developed Countries | Research Methodology | Demographic Factors | Population | Contraceptive Methods | Contraception | Family Planning | Diseases | Contraceptive Agents, Estrogen | Contraceptive Agents, Female | Contraceptive Agents | Contraceptive Safety | Safety | Public Health | Health | Contraceptive Agents, Progestin | Medical Procedures | Medicine | Health Services | Delivery of Health Care Document Number: 295015 |
26.  Title: Comparison of low-dose monophasic oral contraceptive pills and expectant management in treatment of functional ovarian cysts. Author: Sanersak S; Wattanakumtornkul S; Korsakul C Source: Journal of the Medical Association of Thailand. 2006;89(6):741-747. Abstract: The objective was to compare the effectiveness of low-dose monophasic oral contraceptive pills in the treatment of spontaneously occurring functional ovarian cyst detected by ultrasonography compared with expectant management. A total of 70 women in their reproductive period with functional ovarian cysts detected by means of ultrasonography were randomized to low-dose monophasic Oral Contraceptive pills (OC) or to expectant management and followed up at one month with a second ultrasonography. If the ovarian cysts were still present, the women were followed for another month while on the same treatment. At the first month, the remission rates of ovarian cyst were 63.6% in low-dose monophasic OC and 52.9% in expectant groups. At the second month, the cumulative remission rates increased up to 72.7% in lowdose monophasic OC and 67.6% in expectant groups. There was no statistically significant difference between the two groups at both the first and second month of treatment. The most common side effect in women using OC was acne (18%). Low-dose monophasic OC were no more effective than expectant management in the treatment of spontaneously occurring functional ovarian cysts. (author's) Language: English Keywords: THAILAND | RESEARCH REPORT | PROSPECTIVE STUDIES | WOMEN | OVARIAN CYSTS | TREATMENT | ORAL CONTRACEPTIVES, LOW-DOSE | ORAL CONTRACEPTIVES, SIDE EFFECTS | ACNE | Developing Countries | Asia, Southeastern | Asia | Studies | Research Methodology | Demographic Factors | Population | Diseases | Medical Procedures | Medicine | Health Services | Delivery of Health Care | Health | Oral Contraceptives | Contraceptive Methods | Contraception | Family Planning | Contraceptive Safety | Safety | Public Health | Dermatitis Document Number: 301937 |
| 27. Title: Effects of biphasic oral contraceptives containing desogestrel (Oilezz) on cycle control facial acne and seborrhea in healthy Thai women. Author: Wonglikhitpanya N; Taneepanichskul S Source: Journal of the Medical Association of Thailand. 2006;89(6):755-760. Abstract: The objective was to demonstrate the effects of a new biphasic oral contraceptive (Oilezz) on cycle control as well as mild to moderate acne and facial seborrhea of healthy fertile Thai women. The trial is a prospective, open, non-comparative, single center study. Fifty healthy, fertile Thai women with mild to moderate facial acne were recruited to study a specific drug (Oilezz) for 6 months. At the beginning, 66% of the subjects had mild acne and 34% had moderate acne. Significant improvements in facial seborrhea grades (as indicated by Sebutape assessments) were found after the first cycle. These improvements increased steadily and were much larger after the sixth cycle. There were no statistically significant changes in body weight or blood pressure during the study. No serious adverse events were reported. There were no mood changes, migraine, rash, abdominal discomfort, malaise, nausea and decrease in libido during the study period. The premenstrual symptoms at initiation were 21 cases (42%). The symptoms were 4 (8%) with headache, 8 (16%) with breast tenderness, 5 (10%) with dysmenorrhea and one (2%) with bleeding irregularity. These symptoms were improved in the third and the sixth cycles. The percentage of women with spotting or bleeding increased after first cycle, compared with baseline and gradually decreased during subsequent cycles. After the sixth cycle of treatment, all subjects had improvement of acne. 80% of cases recovered from acne and there were only 20% had mild acne. Facial seborrhea and acne improved significantly with Oilezz. It is good to control cycle without change in body weight and blood pressure. Therefore, Oilezz can be used for treatment of seborrhea and acne and as a contraceptive. (author's) Language: English Keywords: THAILAND | RESEARCH REPORT | PROSPECTIVE STUDIES | WOMEN | ACNE | ORAL CONTRACEPTIVES, PHASIC | ORAL CONTRACEPTIVES, SIDE EFFECTS | DERMATOLOGICAL EFFECTS | TREATMENT | Developing Countries | Asia, Southeastern | Asia | Studies | Research Methodology | Demographic Factors | Population | Dermatitis | Diseases | Oral Contraceptives, Combined | Oral Contraceptives | Contraceptive Methods | Contraception | Family Planning | Contraceptive Safety | Safety | Public Health | Health | Physiology | Biology | Medical Procedures | Medicine | Health Services | Delivery of Health Care Document Number: 301938 |
| 28. Peer Reviewed Title: New research eyes OC in acne treatment. Source: Contraceptive Technology Update. 2005 Mar;26(3):[2] p.. Abstract: The next patient in your exam room is an adolescent female, who says she’s interested in birth control pills. Her chief focus? While she’s interested in contraception, she asks several questions about an “acne pill.” According to A Pocket Guide to Managing Contraception, all combined oral contraceptives (OCs) lower free testosterone due to their antiandrogenic compounds. However, only two pills — Ortho Tri-Cyclen (Ortho-McNeil Pharmaceutical, Raritan, NJ) and Estrostep (Warner Chilcott, Rockaway, NJ) — carry an approved indication from the Food and Drug Administration (FDA) for treatment of mild-to-moderate acne. Ortho Tri-Cyclen uses a combination of ethinyl estradiol and norgestimate, while Estrostep uses a mix of ethinyl estradiol and norethindrone acetate. Ortho Tri-Cyclen received its indication based on research published in 1997; Estrostep gained its approval on research published in 2001. Look for other OCs to seek similar acne indications; recently published research indicates that Yasmin (Berlex Laboratories, Montville, NJ), a combination of ethinyl estradiol and drospirenone, also is effective in treating the condition. Other OCs are now being evaluated for possible treatment of acne; two trials involving Alesse (Wyeth-Ayerst Laboratories, Philadelphia) showed total acne improvement of 23%-40% compared with 9%-23% with placebo. Alesse relies on a combination of ethinyl estradiol and levonorgestrel. (excerpt) Language: English Keywords: UNITED STATES OF AMERICA | LITERATURE REVIEW | ADOLESCENTS | ACNE | TREATMENT | ORAL CONTRACEPTIVES, COMBINED | ETHINYL ESTRADIOL | NORETHINDRONE ACETATE | North America | Americas | Developed Countries | Youth | Age Factors | Population Characteristics | Demographic Factors | Population | Dermatitis | Diseases | Oral Contraceptives | Contraceptive Methods | Contraception | Family Planning | Contraceptive Agents, Estrogen | Contraceptive Agents, Female | Contraceptive Agents | Norethindrone | Contraceptive Agents, Progestin Document Number: 281906 |
| 29. Title: Noncontraceptive health benefits of combined oral contraception. Author: European Society for Human Reproduction and Embryology [ESHRE]. Capri Workshop Group Source: Human Reproduction Update. 2005;11(5):513-525. Abstract: Contraception is one of the keystones of reproductive health. The availability of effective contraception has helped to change dramatically the structure of the world's population during the last 50 years, through a demographic transition involving lower fertility rates and longer survival. As the transition evolves more slowly in developing countries, different effects on population structures contribute to civil strains. Oral contraception (OC) is an extremely effective method of contraception that also confers health benefits beyond pregnancy prevention. Notable effects on the reproductive system include relief from troublesome symptoms associated with menstruation such as heavy periods, painful periods and irregular bleeding. Many women also have improvement in acne and hirsutism. Moreover, OCs may be used to treat menorrhagia or symptomatic endometriosis. Use of OCs is associated with a long lasting reduction in the risk of developing cancer of the ovary and the endometrium. The effects on benign breast disease (BBD), bone health and colon cancer are less clear and merit further investigation. (author's) Language: English Keywords: ITALY | RESEARCH REPORT | WOMEN | ORAL CONTRACEPTIVES | TREATMENT | MENSTRUATION DISORDERS | DYSMENORRHEA | ACNE | OVARIAN EFFECTS | MENORRHAGIA | ENDOMETRIAL EFFECTS | Europe, Southern | Europe | Developed Countries | Demographic Factors | Population | Contraceptive Methods | Contraception | Family Planning | Medical Procedures | Medicine | Health Services | Delivery of Health Care | Health | Diseases | Dermatitis | Ovary | Genitalia, Female | Genitalia | Urogenital System | Physiology | Biology | Endometrium | Uterus Document Number: 298429 |
| 30. Title: Insulin-sensitising drugs versus the combined oral contraceptive pill for hirsutism, acne, and risk of diabetes, cardiovascular disease, and endometrial cancer in polycystic ovary syndrome (Protocol). Author: Costello M; Shrestha B; Eden J; Sjoblom P; Johnson N Source: Cochrane Database of Systematic Reviews. 2005;(4):[10] p.. ID: CD005552 Abstract: This is the protocol for a review and there is no abstract. The objectives are as follows: The objective this review are: (1) to assess the effectiveness of insulin-sensitising drugs versus the combined oral contraceptive pill in improving symptoms of hirsutism and acne in PCOS; (2) to assess the effectiveness of insulin-sensitising drugs versus the combined oral contraceptive pill in lowering the risk of developing type 2 diabetes mellitus, cardiovascular disease (stroke, myocardial infarction), and endometrial cancer in women with PCOS; (3) to assess the effectiveness of insulin-sensitising drugs versus the combined oral contraceptive pill in improving other clinical (menstrual cyclicity, body weight, blood pressure), hormonal (androgens) and metabolic (glucose tolerance, insulin sensitivity and lipid levels) parameters (4) to record and assess adverse side effects reported as a result of women with PCOS taking insulin-sensitising drugs versus the combined oral contraceptive pill. (excerpt) Language: English Keywords: GLOBAL | RESEARCH REPORT | LITERATURE REVIEW | CONTRACEPTIVE USE-EFFECTIVENESS | ORAL CONTRACEPTIVES, COMBINED | ACNE | HIRSUTISM | DRUGS | SIDE EFFECTS | TREATMENT | Contraceptive Effectiveness | Contraception | Family Planning | Oral Contraceptives | Contraceptive Methods | Dermatitis | Diseases | Signs and Symptoms | Medical Procedures | Medicine | Health Services | Delivery of Health Care | Health Document Number: 307789 |
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