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The efficacy and safety of an oral contraceptive containing chlormadinone acetate: results of a pooled analysis of noninterventional trials in adult and adolescent women.
Contraception. 2011 Oct; 84(4):390-401.C

Abstract

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®, Grünenthal 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 4-12 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) 0.27-0.42]. 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 0.05-0.12) 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.

Authors+Show Affiliations

Medical Department, Grünenthal GmbH, Zieglerstrasse 6, Aachen, Germany. georg.schramm@grunenthal.comNo affiliation info available

Pub Type(s)

Journal Article
Meta-Analysis
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

21920195

Citation

Schramm, Georg A K., and Guido Schrah. "The Efficacy and Safety of an Oral Contraceptive Containing Chlormadinone Acetate: Results of a Pooled Analysis of Noninterventional Trials in Adult and Adolescent Women." Contraception, vol. 84, no. 4, 2011, pp. 390-401.
Schramm GA, Schrah G. The efficacy and safety of an oral contraceptive containing chlormadinone acetate: results of a pooled analysis of noninterventional trials in adult and adolescent women. Contraception. 2011;84(4):390-401.
Schramm, G. A., & Schrah, G. (2011). The efficacy and safety of an oral contraceptive containing chlormadinone acetate: results of a pooled analysis of noninterventional trials in adult and adolescent women. Contraception, 84(4), 390-401. https://doi.org/10.1016/j.contraception.2011.03.024
Schramm GA, Schrah G. The Efficacy and Safety of an Oral Contraceptive Containing Chlormadinone Acetate: Results of a Pooled Analysis of Noninterventional Trials in Adult and Adolescent Women. Contraception. 2011;84(4):390-401. PubMed PMID: 21920195.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - The efficacy and safety of an oral contraceptive containing chlormadinone acetate: results of a pooled analysis of noninterventional trials in adult and adolescent women. AU - Schramm,Georg A K, AU - Schrah,Guido, Y1 - 2011/05/26/ PY - 2010/07/16/received PY - 2011/02/14/revised PY - 2011/03/29/accepted PY - 2011/9/17/entrez PY - 2011/9/17/pubmed PY - 2012/1/10/medline SP - 390 EP - 401 JF - Contraception JO - Contraception VL - 84 IS - 4 N2 - 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®, Grünenthal 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 4-12 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) 0.27-0.42]. 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 0.05-0.12) 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. SN - 1879-0518 UR - https://www.unboundmedicine.com/medline/citation/21920195/The_efficacy_and_safety_of_an_oral_contraceptive_containing_chlormadinone_acetate:_results_of_a_pooled_analysis_of_noninterventional_trials_in_adult_and_adolescent_women_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0010-7824(11)00156-9 DB - PRIME DP - Unbound Medicine ER -