Rottapharm Rottapharm Madaus Group

Castelfranco di Sopra, Italy

Rottapharm Rottapharm Madaus Group

Castelfranco di Sopra, Italy
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Hadji P.,University of Marburg | Biskup J.,Madaus GmbH | Boekhoff J.,University of Marburg | Ziller M.,University of Marburg | And 2 more authors.
Contraception | Year: 2012

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. © 2012 Elsevier Inc. All rights reserved.

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