Cycle control, safety and efficacy of a 24-day regimen of @entity2081 60 microg/ XXXX 15 microg and a 21-day regimen of desogestrel 150 microg/ @entity2082 20 microg.

@entity1 @entity390 @entity2081 @entity548 @entity2082 @entity5026 @entity391 @entity1867
OBJECTIVE: This multicenter, open-label study was conducted to compare the cycle control, efficacy and safety of a 24-day regimen of a new ultra-low-dose oral contraceptive containing @entity2081 (GTD) 60 microg/ @entity2082 (EE) 15 microg and a 21-day regimen of desogestrel (DSG) 150 microg/EE 20 microg. METHODS: Healthy @entity1 at least 18 years of age who had had regular menstrual cycles for the prior 3 months were randomly assigned to treatment for six cycles. RESULTS: Data from 1074 @entity1 were included in the analyses. Overall, 65% of cycles were normal with GTD/EE and 78% with DSG/EE. The overall incidence of @entity1867 and/or spotting was 29% with GTD/EE and 20% with DSG/EE, with absence of @entity548 occurring in 6% of cycles in the GTD/EE group and 1% of cycles in the DSG/EE group. The GTD/EE group had a significantly shorter length of @entity548 episodes (4 vs. 5 days, p < 0.001), a significantly lower intensity of @entity548 (p < 0.01) and a significantly shorter time for onset of @entity548 than the DSG/EE group (p < 0.001). Safety profiles for the two treatment groups were similar. Significantly more subjects in the DSG/ EE group withdrew because of @entity5026 (p = 0.03) and @entity390 or @entity391 (p = 0.05). One pregnancy occurred in each treatment group. CONCLUSIONS: The 24-day regimen of GTD 60 microg/EE 15 microg provided good efficacy, acceptable cycle control and a favorable safety profile compared with DSG/EE. This ultra-low-dose formulation offers unique advantages in efficacy and safety for oral contraception.
