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Sponsors and Collaborators: |
Bayer TAP Pharmaceutical Products Inc. |
---|---|
Information provided by: | Bayer |
ClinicalTrials.gov Identifier: | NCT00288691 |
The aim of this study is to explore effects of the investigational product for the treatment of treatment-resistant menorrhagia without organic cause.
Condition | Intervention | Phase |
---|---|---|
Menorrhagia |
Drug: Asoprisnil (BAY86-5294) Drug: Placebo |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Multi-Center, Double-Blind, Placebo-Controlled, Randomized, Parallel Group Study to Evaluate the Effects of Different Doses of SH T 00127B in Women With Treatment-Resistant Menorrhagia Aged 30 to 55 Years After Daily Oral Administration of Multiple Doses for 35 up to 50 Days |
Enrollment: | 40 |
Study Start Date: | November 2001 |
Study Completion Date: | February 2004 |
Arms | Assigned Interventions |
---|---|
Arm 1: Experimental |
Drug: Asoprisnil (BAY86-5294)
5mg/day
|
Arm 2: Experimental |
Drug: Asoprisnil (BAY86-5294)
10mg/day
|
Arm 3: Experimental |
Drug: Asoprisnil (BAY86-5294)
25mg/day
|
Arm 4: Placebo Comparator |
Drug: Placebo
Placebo
|
The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany.
Bayer Schering Pharma AG, Germany is the sponsor of the trial.
Ages Eligible for Study: | 30 Years to 55 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Bayer Schering Pharma AG ( Therapeutic Area Head ) |
Study ID Numbers: | 90955, 304667 |
Study First Received: | February 7, 2006 |
Last Updated: | December 11, 2008 |
ClinicalTrials.gov Identifier: | NCT00288691 History of Changes |
Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Treatment-resistant menorrhagia |
Genital Diseases, Female Menstruation Disturbances Uterine Hemorrhage |
Uterine Diseases Menorrhagia Hemorrhage |
Genital Diseases, Female Pathologic Processes Menstruation Disturbances |
Uterine Hemorrhage Uterine Diseases Menorrhagia |