These tools will no longer be maintained as of December 31, 2024. Archived website can be found here. PubMed4Hh GitHub repository can be found here. Contact NLM Customer Service if you have questions.


Pubmed for Handhelds

PUBMED FOR HANDHELDS

Search MEDLINE/PubMed

  • Title: Efficacy and safety of a 21/7-active combined oral contraceptive with continuous low-dose ethinyl estradiol.
    Author: Kroll R, Ackerman R, Feldman R, Howard B, Weiss H, Hsieh J, Ricciotti N.
    Journal: Contraception; 2016 Mar; 93(3):249-56. PubMed ID: 26499407.
    Abstract:
    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. STUDY DESIGN: 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. IMPLICATIONS STATEMENT: 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.
    [Abstract] [Full Text] [Related] [New Search]