Evaluation of efficacy, safety and effects on symptoms of androgenization of a generic oral contraceptive containing chlormadinone acetate 2 mg/ethinylestradiol 0.03 mg.
Contraception
; 86(4): 359-65, 2012 Oct.
Article
in En
| MEDLINE
| ID: mdl-22445436
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. STUDYDESIGN:
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.
Full text:
1
Collection:
01-internacional
Database:
MEDLINE
Main subject:
Virilism
/
Chlormadinone Acetate
/
Drugs, Generic
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Dysmenorrhea
/
Estrogens
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Ethinyl Estradiol
/
Androgen Antagonists
Type of study:
Clinical_trials
/
Diagnostic_studies
/
Etiology_studies
/
Observational_studies
/
Risk_factors_studies
Limits:
Adult
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Female
/
Humans
Language:
En
Journal:
Contraception
Year:
2012
Document type:
Article
Affiliation country: