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Bleeding profile of a flexible extended regimen of ethinylestradiol/drospirenone in US women: an open-label, three-arm, active-controlled, multicenter study.
Contraception. 2012 Aug; 86(2):110-8.C

Abstract

BACKGROUND

Unscheduled bleeding may affect satisfaction and compliance with extended oral contraceptive (OC) regimens. The bleeding patterns of two variants of a flexible dosing regimen designed to manage intracyclic bleeding problems during extended cycles were compared with that of a conventional OC regimen.

STUDY DESIGN

This was a 1-year, open-label, active-controlled, Phase 3 study conducted in the USA. Healthy women (18-45 years) received an ethinylestradiol (EE) 20 mcg/drospirenone 3 mg OC in two flexible extended regimens or in a conventional 24/4 (i.e., 28-day) regimen. The primary regimen [management of intracyclic bleeding (flexible(MIB)) regimen] was an extended dosing regimen that required subjects to initiate 4-day tablet-free intervals after 3 days of breakthrough bleeding/spotting. An alternative extended regimen [active period control (flexible(APC)) regimen] allowed subjects to initiate a 4-day tablet-free interval irrespective of the occurrence of bleeding. Bleeding profiles were compared between treatments. Efficacy and safety outcomes were also assessed.

RESULTS

The full analysis set comprised 1864 women (flexible(MIB), N=1406; flexible(APC), N=232; conventional 24/4, N=226). Over 1 year, subjects in the flexible(MIB) group experienced significantly fewer (mean±SD, 40±30) bleeding/spotting days than those in the conventional 24/4 group (52±35). The corresponding value in the flexible(APC) group was 47±33 days. The pregnancy rate in the flexible(MIB) group was 1.65 per 100 woman-years (95% confidence interval, 0.96-2.65). All three regimens were well tolerated.

CONCLUSION

A flexible(MIB) dosing regimen of EE 20 mcg/drospirenone 3 mg is associated with good contraceptive efficacy and fewer bleeding/spotting days than the conventional 24/4 regimen.

Authors+Show Affiliations

Department of Obstetrics and Gynecology, Oregon Health and Science University, Portland, OR 97239-2941, USA. jensenje@ohsu.eduNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

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

Language

eng

PubMed ID

22281416

Citation

Jensen, Jeffrey T., et al. "Bleeding Profile of a Flexible Extended Regimen of Ethinylestradiol/drospirenone in US Women: an Open-label, Three-arm, Active-controlled, Multicenter Study." Contraception, vol. 86, no. 2, 2012, pp. 110-8.
Jensen JT, Garie SG, Trummer D, et al. Bleeding profile of a flexible extended regimen of ethinylestradiol/drospirenone in US women: an open-label, three-arm, active-controlled, multicenter study. Contraception. 2012;86(2):110-8.
Jensen, J. T., Garie, S. G., Trummer, D., & Elliesen, J. (2012). Bleeding profile of a flexible extended regimen of ethinylestradiol/drospirenone in US women: an open-label, three-arm, active-controlled, multicenter study. Contraception, 86(2), 110-8. https://doi.org/10.1016/j.contraception.2011.12.009
Jensen JT, et al. Bleeding Profile of a Flexible Extended Regimen of Ethinylestradiol/drospirenone in US Women: an Open-label, Three-arm, Active-controlled, Multicenter Study. Contraception. 2012;86(2):110-8. PubMed PMID: 22281416.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Bleeding profile of a flexible extended regimen of ethinylestradiol/drospirenone in US women: an open-label, three-arm, active-controlled, multicenter study. AU - Jensen,Jeffrey T, AU - Garie,Sona Grossova, AU - Trummer,Dietmar, AU - Elliesen,Jörg, Y1 - 2012/01/26/ PY - 2011/10/19/received PY - 2011/12/12/revised PY - 2011/12/12/accepted PY - 2012/1/28/entrez PY - 2012/1/28/pubmed PY - 2013/1/4/medline SP - 110 EP - 8 JF - Contraception JO - Contraception VL - 86 IS - 2 N2 - BACKGROUND: Unscheduled bleeding may affect satisfaction and compliance with extended oral contraceptive (OC) regimens. The bleeding patterns of two variants of a flexible dosing regimen designed to manage intracyclic bleeding problems during extended cycles were compared with that of a conventional OC regimen. STUDY DESIGN: This was a 1-year, open-label, active-controlled, Phase 3 study conducted in the USA. Healthy women (18-45 years) received an ethinylestradiol (EE) 20 mcg/drospirenone 3 mg OC in two flexible extended regimens or in a conventional 24/4 (i.e., 28-day) regimen. The primary regimen [management of intracyclic bleeding (flexible(MIB)) regimen] was an extended dosing regimen that required subjects to initiate 4-day tablet-free intervals after 3 days of breakthrough bleeding/spotting. An alternative extended regimen [active period control (flexible(APC)) regimen] allowed subjects to initiate a 4-day tablet-free interval irrespective of the occurrence of bleeding. Bleeding profiles were compared between treatments. Efficacy and safety outcomes were also assessed. RESULTS: The full analysis set comprised 1864 women (flexible(MIB), N=1406; flexible(APC), N=232; conventional 24/4, N=226). Over 1 year, subjects in the flexible(MIB) group experienced significantly fewer (mean±SD, 40±30) bleeding/spotting days than those in the conventional 24/4 group (52±35). The corresponding value in the flexible(APC) group was 47±33 days. The pregnancy rate in the flexible(MIB) group was 1.65 per 100 woman-years (95% confidence interval, 0.96-2.65). All three regimens were well tolerated. CONCLUSION: A flexible(MIB) dosing regimen of EE 20 mcg/drospirenone 3 mg is associated with good contraceptive efficacy and fewer bleeding/spotting days than the conventional 24/4 regimen. SN - 1879-0518 UR - https://www.unboundmedicine.com/medline/citation/22281416/Bleeding_profile_of_a_flexible_extended_regimen_of_ethinylestradiol/drospirenone_in_US_women:_an_open_label_three_arm_active_controlled_multicenter_study_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0010-7824(11)00741-4 DB - PRIME DP - Unbound Medicine ER -