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Efficacy and safety of a low-dose 24-day combined oral contraceptive containing 20 micrograms ethinylestradiol and 3 mg drospirenone.
Contraception 2004; 70(3):191-8C

Abstract

The aim of this open-label, multicenter, noncomparative study was to determine the efficacy, safety and bleeding profile of a new low-dose, monophasic combined oral contraceptive containing 20 micrograms ethinylestradiol and 3 mg drospirenone administered daily for 24 days followed by a 4-day hormone-free interval. Contraceptive efficacy was analyzed for 1018 women completing 11,140 treatment cycles. Eleven pregnancies occurred, giving a Pearl Index (PI) of 1.29 (upper limit of the 95% confidence interval [CI], 2.30); of these pregnancies, five were considered due to method failure, giving an adjusted PI of 0.72 (upper limit of the 95% CI, 1.69). A total of 7 (0.7%) women discontinued study medication because of irregular bleeding, suggesting a favorable bleeding profile. Overall, the treatment was well tolerated with an excellent safety profile. The majority of women (86%) stated that they were satisfied or very satisfied with the treatment and over 70% of women would have continued with the study medication.

Authors+Show Affiliations

Women's Health Institute, University of Medicine and Dentistry of New Jersey, Robert Wood Johnson Medical School, New Brunswick, NJ, USA.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

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

Language

eng

PubMed ID

15325887

Citation

Bachmann, Gloria, et al. "Efficacy and Safety of a Low-dose 24-day Combined Oral Contraceptive Containing 20 Micrograms Ethinylestradiol and 3 Mg Drospirenone." Contraception, vol. 70, no. 3, 2004, pp. 191-8.
Bachmann G, Sulak PJ, Sampson-Landers C, et al. Efficacy and safety of a low-dose 24-day combined oral contraceptive containing 20 micrograms ethinylestradiol and 3 mg drospirenone. Contraception. 2004;70(3):191-8.
Bachmann, G., Sulak, P. J., Sampson-Landers, C., Benda, N., & Marr, J. (2004). Efficacy and safety of a low-dose 24-day combined oral contraceptive containing 20 micrograms ethinylestradiol and 3 mg drospirenone. Contraception, 70(3), pp. 191-8.
Bachmann G, et al. Efficacy and Safety of a Low-dose 24-day Combined Oral Contraceptive Containing 20 Micrograms Ethinylestradiol and 3 Mg Drospirenone. Contraception. 2004;70(3):191-8. PubMed PMID: 15325887.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Efficacy and safety of a low-dose 24-day combined oral contraceptive containing 20 micrograms ethinylestradiol and 3 mg drospirenone. AU - Bachmann,Gloria, AU - Sulak,Patricia J, AU - Sampson-Landers,Carole, AU - Benda,Norbert, AU - Marr,Joachim, PY - 2004/03/04/received PY - 2004/04/21/revised PY - 2004/05/16/accepted PY - 2004/8/25/pubmed PY - 2005/4/1/medline PY - 2004/8/25/entrez SP - 191 EP - 8 JF - Contraception JO - Contraception VL - 70 IS - 3 N2 - The aim of this open-label, multicenter, noncomparative study was to determine the efficacy, safety and bleeding profile of a new low-dose, monophasic combined oral contraceptive containing 20 micrograms ethinylestradiol and 3 mg drospirenone administered daily for 24 days followed by a 4-day hormone-free interval. Contraceptive efficacy was analyzed for 1018 women completing 11,140 treatment cycles. Eleven pregnancies occurred, giving a Pearl Index (PI) of 1.29 (upper limit of the 95% confidence interval [CI], 2.30); of these pregnancies, five were considered due to method failure, giving an adjusted PI of 0.72 (upper limit of the 95% CI, 1.69). A total of 7 (0.7%) women discontinued study medication because of irregular bleeding, suggesting a favorable bleeding profile. Overall, the treatment was well tolerated with an excellent safety profile. The majority of women (86%) stated that they were satisfied or very satisfied with the treatment and over 70% of women would have continued with the study medication. SN - 0010-7824 UR - https://www.unboundmedicine.com/medline/citation/15325887/Efficacy_and_safety_of_a_low_dose_24_day_combined_oral_contraceptive_containing_20_micrograms_ethinylestradiol_and_3_mg_drospirenone_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0010782404001660 DB - PRIME DP - Unbound Medicine ER -