Evaluation of efficacy, safety and effects on symptoms of androgenization of a generic oral contraceptive containing chlormadinone acetate 2 mg/ethinylestradiol 0.03 mg.

Abstract

BACKGROUND:

This prospective noninterventional study assessed the contraceptive efficacy, safety and the effects on signs of androgenization of the generic oral contraceptive containing 2 mg chlormadinone acetate/0.03 mg ethinylestradiol (CMA/EE) in a real-world setting.

STUDY DESIGN:

A total of 1440 women were investigated during a six-cycle period by 229 gynecological practices throughout Germany.

RESULTS:

The adjusted Pearl index was 0.136 (unadjusted: 0.271). Of 463 patients with cycle irregularities at baseline, 83.4% had regular cycles after six cycles. Likewise, 74.1% of 162 patients with spotting or breakthrough bleeding at baseline were free from these symptoms at the end of study. The percentage of patients with dysmenorrhea decreased significantly from baseline (36.5%) to visit 3 after six cycles (12.3%; p=.0001), with a significant reduction in the use of pain medication (p<.0001). Additionally, the number of patients with skin and hair problems was significantly reduced (skin: 56.3% at baseline, 19.6% after six cycles; hair: 45.7% at baseline, 13.4% after six cycles; p=.001). CMA/EE was well tolerated by the patients, and 89.44% of the gynecologists were satisfied with the treatment.

CONCLUSION:

Generic CMA/EE exhibits very good contraceptive efficacy, cycle control and dysmenorrhea reduction. Furthermore, treatment with generic CMA/EE led to a favorable reduction of skin and hair problems in our study.

• Authors: Peyman Hadji, Jutta Biskup, Jelena Boekhoff, May Ziller, Michael Bonn, Lucio Rovati
• Journal: Contraception (Contraception) Vol. 86 Issue 4 Pg. 359-65 (Oct 2012) ISSN: 1879-0518 [Electronic] United States
• PMID: 22445436 (Publication Type: Journal Article, Multicenter Study, Research Support, Non-U.S. Gov't)
• Copyright: Copyright © 2012 Elsevier Inc. All rights reserved.

Chemical References

• Androgen Antagonists
• Contraceptives, Oral, Combined
• Drug Combinations
• Drugs, Generic
• Estrogens
• Progestins
• ethinylestradiol-chlormadinone acetate
• Chlormadinone Acetate
• Ethinyl Estradiol

Topics

• Adult
• Androgen Antagonists (adverse effects, therapeutic use)
• Chlormadinone Acetate (adverse effects, analogs & derivatives, therapeutic use)
• Contraceptives, Oral, Combined (adverse effects, therapeutic use)
• Drug Combinations
• Drugs, Generic (adverse effects, therapeutic use)
• Dysmenorrhea (drug therapy, physiopathology)
• Estrogens (adverse effects, therapeutic use)
• Ethinyl Estradiol (adverse effects, analogs & derivatives, therapeutic use)
• Female
• Hair Diseases (etiology, prevention & control)
• Humans
• Menstrual Cycle (drug effects)
• Patient Dropouts
• Pelvic Pain (etiology, prevention & control)
• Product Surveillance, Postmarketing
• Progestins (adverse effects, therapeutic use)
• Prospective Studies
• Severity of Illness Index
• Skin Diseases (etiology, prevention & control)
• Virilism (drug therapy, physiopathology)
• Young Adult