A Phase 3 interventional study of Gestodene/EE (FC Patch Low, BAY86-5016) and Oral contraceptive (equivalent to the active treatment tablets of Levlite), 21-day blister SH D00593A in Contraception, sponsored by Bayer. Completed at 28 sites in United States. Open to female participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-10-09.
Sponsored by Bayer · Phase 3, Interventional, and Prevention
Birth Control Patch Study
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Of its 209 completed or terminated interventional studies of FDA-regulated products, 129 (62%) have results posted.
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Exclusion Criteria:
Drug: Gestodene/EE (FC Patch Low, BAY86-5016)
Drug: Oral contraceptive (equivalent to the active treatment tablets of Levlite), 21-day blister SH D00593A
21-day regimen per cycle (1 patch a week for 3 weeks followed by a 7-day patch-free period) for 7 cycles and placebo tablets matching the conditions of the treatment of Arm 2
21-day regimen per cycle (1 tablet a day for 3 weeks followed by a 7-day tablet-free period) for 7 cycles and placebo patches matching the conditions of the treatment of Arm 1
Cycle control parameters and bleeding pattern indices
Time frame: Treatment cycles 2-7
Number of pregnancies while on treatment up to 14 days after removal of the last patch
Time frame: 7 treatment cycles each consisting of 28 days and follow-up period of 14 days
Evaluation of blood pressure changes during the dosing-free interval
Time frame: 7 treatment cycles each consisting of 28 days
This study is completed, as verified in Jan 2014. You cannot join it, but the record below documents what was studied.
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