The efficacy and safety of an oral contraceptive containing chlormadinone acetate: results of a pooled analysis of noninterventional trials in adult and adolescent women

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• 作者：Georg A.K.  ; Schramm^a ;   ; ^{georg.schramm@grunenthal.com} ; Guido  ; Schrah^b
• 关键词：Chlormadinone acetate/ethinylestradiol ; CME/EE ; Pooled analysis ; Noninterventional trial ; Adolescent ; Adult women
• 刊名：Contraception
• 出版年：2011
• 出版时间：October 2011
• 年：2011
• 卷：84
• 期：4
• 页码：390-401
• 全文大小：194 K

文摘

Background

The study was conducted to assess the contraceptive efficacy, cycle events, dysmenorrhea symptoms and skin complaints of a combined oral contraceptive containing 2 mg chlormadinone acetate/0.03 mg ethinylestradiol (CMA/EE) (Belara?, Gr¨¹nenthal GmbH, Aachen, Germany) in adolescent and adult women using a conventional- or extended-cycle regimen.

Study Design

Data were pooled from six noninterventional trials with CMA/EE intake over 4?2 cycles.

Results

The data pool contained 62,218 women (345,964 cycles), of whom 60,508 were analyzed (325,937.5 cycles), including 46,335 adults, 13,478 adolescents and 695 age unknown; 1710 retrospective documented patients were excluded from analysis. A total of 85 women became pregnant (including women missing pills) on the conventional-cycle regimen (21+7), giving a practical Pearl index of 0.34 [95 % confidence interval (CI) 0.27?.42]. Within this group (n=85), there were 19 pregnancies associated with regular pill intake, which represent a theoretical Pearl index of 0.08 (95 % CI 0.05?.12) per 100 women-years. Overall, cycle stability, bleeding profile, dysmenorrhea and the incidence of seborrhea/acne improved with CMA/EE, and there was no clinically relevant change in body weight or body mass index. Six venous thromboembolic events were reported, equating to an incidence of 2.4 per 10,000 women-years.

Conclusions

Chlormadinone acetate/ethinylestradiol is effective and well tolerated in adolescent and adult women.