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Long-term efficacy and safety of a monophasic combined oral contraceptive containing 0.02 mg ethinylestradiol and 2 mg chlormadinone acetate administered in a 24/4-day regimen.
Contraception. 2010 Jun; 81(6):501-9.C

Abstract

OBJECTIVE

This study was conducted to assess the long-term efficacy and safety of a low-dose monophasic combined oral contraceptive (COC) containing 0.02 mg ethinylestradiol (EE) and 2 mg chlormadinone acetate (CMA) in a novel regimen administered daily for 24 days followed by a 4-day placebo interval.

STUDY DESIGN

In this multicenter, uncontrolled, Phase III trial, 1665 subjects took the COC 0.02 mg EE/2 mg CMA for up to 21 cycles. The overall Pearl Index was the primary end point; cycle control, safety, effect on acne and seborrhea, and changes in body weight and libido were secondary end points.

RESULTS

Contraceptive efficacy was analyzed for 1653 subjects completing 21,495 cycles. Six pregnancies occurred during trial duration with one attributable to method failure. The overall Pearl Index for the first year of use was 0.33 (95% confidence interval, 0.09-0.85). The mean number of bleeding/spotting days during six 90-day reference periods (RPs) decreased from 17.0 (RP 1) to 11.7 (RP 6), and the number of bleeding episodes per RP decreased from 3.8 (RP 1) to 2.7 (RP 6). Among subjects who presented with acne at the baseline visit, a decrease of papules/pustules and comedones was observed during the course of the trial. The most common "at least possibly related" adverse events were headache, breast discomfort and nausea. The tolerability and well-being was reported as being excellent or good in the majority of trial subjects (84.6% and 80.2%, respectively).

CONCLUSIONS

The low-dose COC 0.02 mg EE/2 mg CMA administered daily for 24 days followed by a 4-day placebo interval provides high contraceptive efficacy combined with an adequate cycle control and safety profile, beneficial effects on acne, and is well tolerated.

Authors+Show Affiliations

Klinikum Nürnberg Nord, Klinik für Frauenheilkunde, Prof.-Ernst-Nathan-Str. 1, Nürnberg, Germany. cosima.brucker@klinikum-nuernberg.deNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial, Phase III
Journal Article
Multicenter Study
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

20472117

Citation

Brucker, Cosima, et al. "Long-term Efficacy and Safety of a Monophasic Combined Oral Contraceptive Containing 0.02 Mg Ethinylestradiol and 2 Mg Chlormadinone Acetate Administered in a 24/4-day Regimen." Contraception, vol. 81, no. 6, 2010, pp. 501-9.
Brucker C, Hedon B, The HS, et al. Long-term efficacy and safety of a monophasic combined oral contraceptive containing 0.02 mg ethinylestradiol and 2 mg chlormadinone acetate administered in a 24/4-day regimen. Contraception. 2010;81(6):501-9.
Brucker, C., Hedon, B., The, H. S., Höschen, K., Binder, N., & Christoph, A. (2010). Long-term efficacy and safety of a monophasic combined oral contraceptive containing 0.02 mg ethinylestradiol and 2 mg chlormadinone acetate administered in a 24/4-day regimen. Contraception, 81(6), 501-9. https://doi.org/10.1016/j.contraception.2010.01.011
Brucker C, et al. Long-term Efficacy and Safety of a Monophasic Combined Oral Contraceptive Containing 0.02 Mg Ethinylestradiol and 2 Mg Chlormadinone Acetate Administered in a 24/4-day Regimen. Contraception. 2010;81(6):501-9. PubMed PMID: 20472117.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Long-term efficacy and safety of a monophasic combined oral contraceptive containing 0.02 mg ethinylestradiol and 2 mg chlormadinone acetate administered in a 24/4-day regimen. AU - Brucker,Cosima, AU - Hedon,Bernard, AU - The,Hok Sien, AU - Höschen,Kornelia, AU - Binder,Natascha, AU - Christoph,Annette, Y1 - 2010/02/19/ PY - 2008/09/16/received PY - 2010/01/11/revised PY - 2010/01/13/accepted PY - 2010/5/18/entrez PY - 2010/5/18/pubmed PY - 2010/8/19/medline SP - 501 EP - 9 JF - Contraception JO - Contraception VL - 81 IS - 6 N2 - OBJECTIVE: This study was conducted to assess the long-term efficacy and safety of a low-dose monophasic combined oral contraceptive (COC) containing 0.02 mg ethinylestradiol (EE) and 2 mg chlormadinone acetate (CMA) in a novel regimen administered daily for 24 days followed by a 4-day placebo interval. STUDY DESIGN: In this multicenter, uncontrolled, Phase III trial, 1665 subjects took the COC 0.02 mg EE/2 mg CMA for up to 21 cycles. The overall Pearl Index was the primary end point; cycle control, safety, effect on acne and seborrhea, and changes in body weight and libido were secondary end points. RESULTS: Contraceptive efficacy was analyzed for 1653 subjects completing 21,495 cycles. Six pregnancies occurred during trial duration with one attributable to method failure. The overall Pearl Index for the first year of use was 0.33 (95% confidence interval, 0.09-0.85). The mean number of bleeding/spotting days during six 90-day reference periods (RPs) decreased from 17.0 (RP 1) to 11.7 (RP 6), and the number of bleeding episodes per RP decreased from 3.8 (RP 1) to 2.7 (RP 6). Among subjects who presented with acne at the baseline visit, a decrease of papules/pustules and comedones was observed during the course of the trial. The most common "at least possibly related" adverse events were headache, breast discomfort and nausea. The tolerability and well-being was reported as being excellent or good in the majority of trial subjects (84.6% and 80.2%, respectively). CONCLUSIONS: The low-dose COC 0.02 mg EE/2 mg CMA administered daily for 24 days followed by a 4-day placebo interval provides high contraceptive efficacy combined with an adequate cycle control and safety profile, beneficial effects on acne, and is well tolerated. SN - 1879-0518 UR - https://www.unboundmedicine.com/medline/citation/20472117/Long_term_efficacy_and_safety_of_a_monophasic_combined_oral_contraceptive_containing_0_02_mg_ethinylestradiol_and_2_mg_chlormadinone_acetate_administered_in_a_24/4_day_regimen_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0010-7824(10)00012-0 DB - PRIME DP - Unbound Medicine ER -