Tags

Type your tag names separated by a space and hit enter

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. 2012 Oct; 86(4):359-65.C

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+Show Affiliations

Philipps-University of Marburg, Department of Gynecological Endocrinology, Reproductive Medicine and Osteoporosis, 35043 Marburg, Germany.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Multicenter Study
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

22445436

Citation

Hadji, Peyman, et al. "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, vol. 86, no. 4, 2012, pp. 359-65.
Hadji P, Biskup J, Boekhoff J, et al. 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. 2012;86(4):359-65.
Hadji, P., Biskup, J., Boekhoff, J., Ziller, M., Bonn, M., & Rovati, L. (2012). 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. https://doi.org/10.1016/j.contraception.2012.02.004
Hadji P, et al. 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. 2012;86(4):359-65. PubMed PMID: 22445436.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Evaluation of efficacy, safety and effects on symptoms of androgenization of a generic oral contraceptive containing chlormadinone acetate 2 mg/ethinylestradiol 0.03 mg. AU - Hadji,Peyman, AU - Biskup,Jutta, AU - Boekhoff,Jelena, AU - Ziller,May, AU - Bonn,Michael, AU - Rovati,Lucio, Y1 - 2012/03/23/ PY - 2011/06/10/received PY - 2012/02/06/revised PY - 2012/02/06/accepted PY - 2012/3/27/entrez PY - 2012/3/27/pubmed PY - 2013/2/1/medline SP - 359 EP - 65 JF - Contraception JO - Contraception VL - 86 IS - 4 N2 - 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. SN - 1879-0518 UR - https://www.unboundmedicine.com/medline/citation/22445436/Evaluation_of_efficacy_safety_and_effects_on_symptoms_of_androgenization_of_a_generic_oral_contraceptive_containing_chlormadinone_acetate_2_mg/ethinylestradiol_0_03_mg_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0010-7824(12)00054-6 DB - PRIME DP - Unbound Medicine ER -