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Efficacy and safety of a low-dose combined oral contraceptive containing drospirenone 3 mg and ethinylestradiol 20 mcg in a 24/4-day regimen.
Contraception. 2009 Jul; 80(1):18-24.C

Abstract

OBJECTIVE

The study was conducted to assess the efficacy of a low-dose combined oral contraceptive (COC) containing drospirenone (drsp) 3 mg/ethinylestradiol (EE) 20 mcg administered for 24 days of active treatment followed by a 4-day hormone-free interval (24/4 regimen).

STUDY DESIGN

In this open-label uncontrolled study conducted in 50 European centers, healthy females aged 18-35 years with a body mass index of less than 30 kg/m(2) received drsp 3 mg/EE 20 mcg 24/4 over 13 cycles. The primary efficacy variable was the number of unintended pregnancies.

RESULTS

Five pregnancies occurred among 1101 women over 13,248 treatment cycles, resulting in a Pearl Index (PI) of 0.49 with an upper two-sided 95% CI limit of 1.14. Of these pregnancies, three were attributed to noncompliance with tablet use resulting in an adjusted PI for 'perfect use' of 0.22 (upper limit of two-sided 95% CI: 0.80) based on 11,755 cycles.

CONCLUSION

Drospirenone 3 mg/EE 20 mcg 24/4 is a highly effective COC in nonobese women.

Authors+Show Affiliations

Department of Obstetrics and Gynaecology, Markhot F. Heves County Hospital, Eger, Hungary.No 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

19501211

Citation

Hernádi, László, et al. "Efficacy and Safety of a Low-dose Combined Oral Contraceptive Containing Drospirenone 3 Mg and Ethinylestradiol 20 Mcg in a 24/4-day Regimen." Contraception, vol. 80, no. 1, 2009, pp. 18-24.
Hernádi L, Marr J, Trummer D, et al. Efficacy and safety of a low-dose combined oral contraceptive containing drospirenone 3 mg and ethinylestradiol 20 mcg in a 24/4-day regimen. Contraception. 2009;80(1):18-24.
Hernádi, L., Marr, J., Trummer, D., De Leo, V., & Petraglia, F. (2009). Efficacy and safety of a low-dose combined oral contraceptive containing drospirenone 3 mg and ethinylestradiol 20 mcg in a 24/4-day regimen. Contraception, 80(1), 18-24. https://doi.org/10.1016/j.contraception.2009.01.016
Hernádi L, et al. Efficacy and Safety of a Low-dose Combined Oral Contraceptive Containing Drospirenone 3 Mg and Ethinylestradiol 20 Mcg in a 24/4-day Regimen. Contraception. 2009;80(1):18-24. PubMed PMID: 19501211.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Efficacy and safety of a low-dose combined oral contraceptive containing drospirenone 3 mg and ethinylestradiol 20 mcg in a 24/4-day regimen. AU - Hernádi,László, AU - Marr,Joachim, AU - Trummer,Dietmar, AU - De Leo,Vincenzo, AU - Petraglia,Felice, Y1 - 2009/03/18/ PY - 2008/05/27/received PY - 2009/01/23/revised PY - 2009/01/28/accepted PY - 2009/6/9/entrez PY - 2009/6/9/pubmed PY - 2009/9/16/medline SP - 18 EP - 24 JF - Contraception JO - Contraception VL - 80 IS - 1 N2 - OBJECTIVE: The study was conducted to assess the efficacy of a low-dose combined oral contraceptive (COC) containing drospirenone (drsp) 3 mg/ethinylestradiol (EE) 20 mcg administered for 24 days of active treatment followed by a 4-day hormone-free interval (24/4 regimen). STUDY DESIGN: In this open-label uncontrolled study conducted in 50 European centers, healthy females aged 18-35 years with a body mass index of less than 30 kg/m(2) received drsp 3 mg/EE 20 mcg 24/4 over 13 cycles. The primary efficacy variable was the number of unintended pregnancies. RESULTS: Five pregnancies occurred among 1101 women over 13,248 treatment cycles, resulting in a Pearl Index (PI) of 0.49 with an upper two-sided 95% CI limit of 1.14. Of these pregnancies, three were attributed to noncompliance with tablet use resulting in an adjusted PI for 'perfect use' of 0.22 (upper limit of two-sided 95% CI: 0.80) based on 11,755 cycles. CONCLUSION: Drospirenone 3 mg/EE 20 mcg 24/4 is a highly effective COC in nonobese women. SN - 1879-0518 UR - https://www.unboundmedicine.com/medline/citation/19501211/Efficacy_and_safety_of_a_low_dose_combined_oral_contraceptive_containing_drospirenone_3_mg_and_ethinylestradiol_20_mcg_in_a_24/4_day_regimen_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0010-7824(09)00037-7 DB - PRIME DP - Unbound Medicine ER -