Duramed clinical trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Prostate Cancer.

Phase 2. Study Type :. Interventional Clinical Trial. Actual Enrollment :. Study Start Date :. Actual Primary Completion Date :. Actual Study Completion Date :. Experimental: Cyproterone acetate 5 mg DR 1 tablet daily. Experimental: Cyproterone acetate 15 mg DR 1 tablet daily.

Experimental: Cyproterone acetate 25 mg DR 1 tablet daily. Placebo Comparator: Placebo 1 tablet daily. Drug: Placebo Matching placebo. San Bernardino, California, United States, Washington, District of Columbia, United States, Philadelphia, Pennsylvania, United States, Sellersville, Pennsylvania, United States, State College, Pennsylvania, United States, Charleston, South Carolina, United States, Read our disclaimer for details.

Last Update Posted : April 8, Study Description. This study is being conducted to evaluate the safety of ethinyl an extended-regimen oral contraceptive, with ethinyl estradiol supplementation during the usual hormone-free week, for up to an additional three consecutive years. Detailed Description:. This study is being conducted to evaluate the safety of an extended-regimen oral contraceptive, with ethinyl estradiol supplementation during the usual hormone-free week, for up to an additional three consecutive years.

This is an extension of the Seasonique Phase 3 clinical trial to evaluate long-term safety. Only patients enrolled in the earlier trial are eligible for participation. FDA Resources. Arms and Interventions. Outcome Measures. Eligibility Criteria. Information from the National Library of Medicine Choosing to participate in a study is an important personal decision. Inclusion Criteria: Participant in the earlier Phase 3 Seasonique clinical trial Exclusion Criteria: Any contraindication to the use of oral contraceptives.

Study Description. This is a multicenter study to evaluate the efficacy and safety of 2 different doses of DR For eligible subjects the duration of the study will be approximately 20 weeks; this will consist of a 4-week screening period, a week treatment period and a 4-week follow-up period. Subjects will have physical and laboratory exams, including blood draws at each scheduled visit. Subjects will be required to insert a vaginal ring replacing it every 4 weeks and to keep a daily record of their toilet voids including time,type and volume for 3 days at several specified time points.

Arms and Interventions. Placebo vaginal ring inserted vaginally and replaced every 4 weeks. Outcome Measures. Eligibility Criteria. Information from the National Library of Medicine Choosing to participate in a study is an important personal decision. Contacts and Locations. Information from the National Library of Medicine To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials. More Information. National Library of Medicine U. National Institutes of Health U.