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Cycle control and bleeding pattern of a 24/4 regimen of drospirenone 3 mg/ethinylestradiol 20 μg compared with a 21/7 regimen of desogestrel 150 μg/ethinylestradiol 20 μg: a pooled analysis.
Clin Drug Investig. 2011; 31(8):519-525.CD

Abstract

BACKGROUND AND OBJECTIVE

The degree of cycle control achieved with a hormonal contraceptive method is an important determinant of its acceptance and continuation. This study set out to compare the cycle control and bleeding profile of drospirenone (DRSP) 3 mg/ethinylestradiol (EE) 20 μg in a 24-active pill/4-inert pill (24/4) regimen (YAZ®) with those of desogestrel (DSG) 150 μg/EE 20 μg in a 21/7 regimen (Mercilon®), an established European combined oral contraceptive (COC).

METHODS

Bleeding data from women aged 17-36 years who received either DRSP 3 mg/EE 20 μg in a 24/4 regimen (n = 1285) or DSG 150 μg/EE 20 μg in a 21/7 regimen (n = 471) during four clinical studies were pooled and analysed over seven treatment cycles.

RESULTS

The maximum intensity of scheduled withdrawal bleeding was 'normal bleeding' for >50% of subjects in cycles 1-6 in both treatment groups. Moreover, the incidence of unscheduled intracyclic bleeding during cycles 2-7 was comparable between treatment types (10.2-14.9% in women treated with DRSP 3 mg/EE 20 μg 24/4 vs 8.6-13.8% in women treated with DSG 150 μg/EE 20 μg 21/7). Overall, similar bleeding patterns were observed with both treatments.

CONCLUSION

DRSP 3 mg/EE 20 μg 24/4 is associated with a bleeding profile and cycle control that is comparable to that of an established, low-dose COC formulation.

Authors+Show Affiliations

The Family Federation of Finland, Turku Clinic, Turku, Finland. marja-leena.anttila@vaestoliitto.fi.Department of Gynaecology and Obstetrics, District Hospital of Dornbirn, Dornbirn, Austria.Department of Pediatrics, Obstetrics and Reproductive Medicine, Division of Obstetrics and Gynecology, University of Siena, Siena, Italy.Global Clinical Development, Women's Healthcare, Bayer HealthCare Pharmaceuticals, Berlin, Germany.Global Clinical Development, Women's Healthcare, Bayer HealthCare Pharmaceuticals, Berlin, Germany.

Pub Type(s)

Clinical Trial
Comparative Study
Journal Article
Meta-Analysis
Multicenter Study
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

21721590

Citation

Anttila, Leena, et al. "Cycle Control and Bleeding Pattern of a 24/4 Regimen of Drospirenone 3 Mg/ethinylestradiol 20 Μg Compared With a 21/7 Regimen of Desogestrel 150 Μg/ethinylestradiol 20 Μg: a Pooled Analysis." Clinical Drug Investigation, vol. 31, no. 8, 2011, pp. 519-525.
Anttila L, Neunteufel W, Petraglia F, et al. Cycle control and bleeding pattern of a 24/4 regimen of drospirenone 3 mg/ethinylestradiol 20 μg compared with a 21/7 regimen of desogestrel 150 μg/ethinylestradiol 20 μg: a pooled analysis. Clin Drug Investig. 2011;31(8):519-525.
Anttila, L., Neunteufel, W., Petraglia, F., Marr, J., & Kunz, M. (2011). Cycle control and bleeding pattern of a 24/4 regimen of drospirenone 3 mg/ethinylestradiol 20 μg compared with a 21/7 regimen of desogestrel 150 μg/ethinylestradiol 20 μg: a pooled analysis. Clinical Drug Investigation, 31(8), 519-525. https://doi.org/10.2165/11590260-000000000-00000
Anttila L, et al. Cycle Control and Bleeding Pattern of a 24/4 Regimen of Drospirenone 3 Mg/ethinylestradiol 20 Μg Compared With a 21/7 Regimen of Desogestrel 150 Μg/ethinylestradiol 20 Μg: a Pooled Analysis. Clin Drug Investig. 2011;31(8):519-525. PubMed PMID: 21721590.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Cycle control and bleeding pattern of a 24/4 regimen of drospirenone 3 mg/ethinylestradiol 20 μg compared with a 21/7 regimen of desogestrel 150 μg/ethinylestradiol 20 μg: a pooled analysis. AU - Anttila,Leena, AU - Neunteufel,Walter, AU - Petraglia,Felice, AU - Marr,Joachim, AU - Kunz,Michael, PY - 2011/7/5/entrez PY - 2011/7/5/pubmed PY - 2011/11/2/medline SP - 519 EP - 525 JF - Clinical drug investigation JO - Clin Drug Investig VL - 31 IS - 8 N2 - BACKGROUND AND OBJECTIVE: The degree of cycle control achieved with a hormonal contraceptive method is an important determinant of its acceptance and continuation. This study set out to compare the cycle control and bleeding profile of drospirenone (DRSP) 3 mg/ethinylestradiol (EE) 20 μg in a 24-active pill/4-inert pill (24/4) regimen (YAZ®) with those of desogestrel (DSG) 150 μg/EE 20 μg in a 21/7 regimen (Mercilon®), an established European combined oral contraceptive (COC). METHODS: Bleeding data from women aged 17-36 years who received either DRSP 3 mg/EE 20 μg in a 24/4 regimen (n = 1285) or DSG 150 μg/EE 20 μg in a 21/7 regimen (n = 471) during four clinical studies were pooled and analysed over seven treatment cycles. RESULTS: The maximum intensity of scheduled withdrawal bleeding was 'normal bleeding' for >50% of subjects in cycles 1-6 in both treatment groups. Moreover, the incidence of unscheduled intracyclic bleeding during cycles 2-7 was comparable between treatment types (10.2-14.9% in women treated with DRSP 3 mg/EE 20 μg 24/4 vs 8.6-13.8% in women treated with DSG 150 μg/EE 20 μg 21/7). Overall, similar bleeding patterns were observed with both treatments. CONCLUSION: DRSP 3 mg/EE 20 μg 24/4 is associated with a bleeding profile and cycle control that is comparable to that of an established, low-dose COC formulation. SN - 1179-1918 UR - https://www.unboundmedicine.com/medline/citation/21721590/Cycle_control_and_bleeding_pattern_of_a_24/4_regimen_of_drospirenone_3_mg/ethinylestradiol_20_μg_compared_with_a_21/7_regimen_of_desogestrel_150_μg/ethinylestradiol_20_μg:_a_pooled_analysis_ L2 - https://dx.doi.org/10.2165/11590260-000000000-00000 DB - PRIME DP - Unbound Medicine ER -