OBJECTIVE: Substituting low-dose @entity2082 (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 @entity7281 ( @entity5252 )/EE followed by 7days of EE. STUDY DESIGN: This multicenter, open-label, phase 3, single-arm study enrolled sexually active @entity1 aged 18-40years at risk for pregnancy. @entity1 received up to 1year, or 13 consecutive 28-day cycles, of @entity5252 150mcg/EE 20mcg for 21days and EE 10mcg alone for 7days. @entity1 kept diaries to record compliance, @entity548 /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 @entity1 enrolled and 1680 completed the study. Forty-six pregnancies in 2401 @entity1 aged 18-35years occurred after @entity11718 initiation and up to 7days after last @entity5252 /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 @entity1 considered compliant were included, the PI was 2.00 (95% CI, 1.39-2.80). AEs were similar to those seen with other @entity7280 . CONCLUSIONS: This 21/7-active @entity5252 /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 @entity5252 150mcg/EE 20mcg and 7days of EE 10mcg was efficacious and well tolerated for pregnancy prevention.

Efficacy and safety of a 21/7-active combined oral contraceptive with continuous low-dose XXXX .

@entity1 :: ('9606', 'Species') :: ['women', 'Women', 'Participants'] @entity548 :: ('MESH:D006470', 'Disease') :: ['bleeding'] @entity11718 :: ('CHEBI:28887', 'Chemical') :: ['COC'] @entity2082 :: ('MESH:D004997', 'Chemical') :: ['ethinyl estradiol'] @entity7281 :: ('MESH:D017135', 'Chemical') :: ['desogestrel'] @entity5252 :: ('CHEBI:62094', 'Chemical') :: ['DSG'] @entity7280 :: ('MESH:D003276', 'Chemical') :: ['oral contraceptives']
@entity2082 :: (MESH:D004997,Chemical) :: ['ethinyl estradiol']
