Efficacy and safety of a 21/7-active combined oral contraceptive with continuous low-dose ethinyl estradiol.
OBJECTIVE
Substituting low-dose ethinyl estradiol (EE) for the hormone-free interval in combined oral contraceptives (COCs) may enhance ovarian suppression and improve tolerability. This noncomparative phase 3 study evaluated the efficacy and safety of a 21/7-active COC regimen including 21days of desogestrel (DSG)/EE followed by 7days of EE.


METHODS
This multicenter, open-label, phase 3, single-arm study enrolled sexually active women aged 18-40years at risk for pregnancy. Women received up to 1year, or 13 consecutive 28-day cycles, of DSG 150mcg/EE 20mcg for 21days and EE 10mcg alone for 7days. Participants kept diaries to record compliance, bleeding/spotting and other contraceptive use. Efficacy was measured using the Pearl Index (PI) and life-table approach. Safety and tolerability were assessed primarily through reported adverse events (AEs).


RESULTS
A total of 2858 women enrolled and 1680 completed the study. Forty-six pregnancies in 2401 women aged 18-35years occurred after COC initiation and up to 7days after last DSG/EE or EE-only tablet was taken. When cycles in which another contraceptive method was used were excluded, the PI was 2.68 [95% confidence interval (CI), 1.96-3.57]. The cumulative pregnancy rate after 1year of treatment was 2.47% (95% CI, 1.85-3.29) for all users aged 18-35years. When only cycles during which women considered compliant were included, the PI was 2.00 (95% CI, 1.39-2.80). AEs were similar to those seen with other oral contraceptives.


CONCLUSIONS
This 21/7-active DSG/EE COC with 7days of low-dose EE was efficacious and well tolerated for pregnancy prevention.


CONCLUSIONS
This phase 3 open-label study demonstrated that a 21/7-active COC regimen including 21days of DSG 150mcg/EE 20mcg and 7days of EE 10mcg was efficacious and well tolerated for pregnancy prevention.
Women's Clinical Research Center, 3216 NE 45th Place, Suite 100, Seattle, WA 98105, USA. Electronic address: rkroll@seattlewomens.com.
Robin
R
Kroll
Comprehensive Clinical Trials LLC, 603 Village Blvd., Suite 301, West Palm Beach, FL 33409, USA. Electronic address: gobs@earthlink.net.
Ronald
R
Ackerman
Miami Research Associates, 6141 Sunset Drive, Miami, FL 33143, USA. Electronic address: rfeldman@miamiresearch.com.
Robert
R
Feldman
Teva Global Medical Affairs, 41 Moores Road, Frazer, PA 19355, USA. Electronic address: Brandon.Howard@tevapharm.com.
Brandon
B
Howard
Teva Global Medical Affairs, 16 Basel St., Room 1041, Petach Tikva 49131, Israel. Electronic address: Herman.Weiss@teva.co.il.
Herman
H
Weiss
Teva Branded Pharmaceutical Products R&D Inc., 905 Airport Road, West Chester, PA 19380, USA. Electronic address: Jennifer.Hsieh@tevapharm.com.
Jennifer
J
Hsieh
Teva Branded Pharmaceutical Products R&D Inc., 41 Moores Road, Frazer, PA 19355, USA. Electronic address: nancyricciotti@gmail.com.
Nancy
N
Ricciotti
D000293:Adolescent; D000328:Adult; D003277:Contraceptives, Oral, Combined / Q000008:administration & dosage* / Q000009:adverse effects*; D017135:Desogestrel / Q000008:administration & dosage / Q000009:adverse effects; D004997:Ethinyl Estradiol / Q000008:administration & dosage* / Q000009:adverse effects*; D005260:Female; D006801:Humans; D008597:Menstrual Cycle; D011247:Pregnancy; D018873:Pregnancy Rate; D055815:Young Adult
D003277:Contraceptives, Oral, Combined; D004997:Ethinyl Estradiol; D017135:Desogestrel
Birth control pill; Contraception; Hormone-free interval; Phase 3 trial