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.

Publisher: Adis, Springer International Country of Publication: New Zealand NLM ID: 9504817 Publication Model: Print Cited Medium: Internet ISSN: 1179-1918 (Electronic) Linking ISSN: 11732563 NLM ISO Abbreviation: Clin Drug Investig Subsets: MEDLINE

Publication: Auckland : Adis, Springer International
Original Publication: Mairangi Bay, Auckland, N.Z. ; Philadelphia : Adis International, c1995-

Menstruation*; Androstenes/*administration & dosage ; Contraceptives, Oral/*administration & dosage ; Contraceptives, Oral, Combined/*administration & dosage ; Desogestrel/*administration & dosage ; Ethinyl Estradiol/*administration & dosage ; Menstrual Cycle/*drug effects; Adolescent ; Adult ; Androstenes/adverse effects ; Contraceptives, Oral/adverse effects ; Contraceptives, Oral, Combined/adverse effects ; Desogestrel/adverse effects ; Ethinyl Estradiol/adverse effects ; Female ; Humans ; Metrorrhagia ; Young Adult

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.

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0 (Androstenes)
0 (Contraceptives, Oral)
0 (Contraceptives, Oral, Combined)
0 (drospirenone and ethinyl estradiol combination)
0 (ethinyl estradiol-desogestrel combination)
423D2T571U (Ethinyl Estradiol)
81K9V7M3A3 (Desogestrel)

Date Created: 20110705 Date Completed: 20111101 Latest Revision: 20241219

20250114

10.2165/11590260-000000000-00000

21721590