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Sponsored by: |
Abbott |
---|---|
Information provided by: | Abbott |
ClinicalTrials.gov Identifier: | NCT00152282 |
The objective of this study is to determine the safety and effectiveness of 3 asoprisnil doses when administered to postmenopausal women with Premarin® 0.625 mg.
Condition | Intervention | Phase |
---|---|---|
Amenorrhea Postmenopause |
Drug: Asoprisnil/Premarin Drug: Placebo and Premarin |
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 Phase II Pilot Study to Evaluate the Safety and Efficacy of J867 Administered With Estrogen to Postmenopausal Women |
Enrollment: | 105 |
Study Start Date: | September 2000 |
Study Completion Date: | August 2001 |
Primary Completion Date: | August 2001 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental |
Drug: Asoprisnil/Premarin
Asoprisnil 5mg and Premarin 0.625 mg Tablets, oral Daily for 12 weeks
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2: Experimental |
Drug: Asoprisnil/Premarin
Asoprisnil 10mg and Premarin 0.625 mg Tablets, oral Daily for 12 weeks
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3: Experimental |
Drug: Asoprisnil/Premarin
Asoprisnil 25mg and Premarin 0.625 mg Tablets, oral Daily for 12 weeks
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4: Placebo Comparator |
Drug: Placebo and Premarin
Placebo and Premarin 0.625 mg Tablets, oral Daily for 12 weeks
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The objective of this study is to determine the safety and effectiveness of asoprisnil 5, 10, and 25 mg, compared to placebo, when administered to postmenopausal women, with Premarin® 0.625 mg, for 12 weeks. Pharmacodynamic effects to be assessed include bleeding pattern, endometrial biopsy results, and endometrial thickness. Safety assessments will include clinical laboratory results, physical examination with vital signs, pelvic and breast examinations, ultrasound results, and adverse events
Ages Eligible for Study: | 48 Years to 65 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Abbott ( Cynthia Mattia-Goldberg ) |
Study ID Numbers: | M00-198 |
Study First Received: | September 7, 2005 |
Last Updated: | May 27, 2008 |
ClinicalTrials.gov Identifier: | NCT00152282 |
Health Authority: | United States: Food and Drug Administration |
Postmenopausal Amenorrhea Hormone replacement therapy HRT asoprisnil |
Estrogens, Conjugated (USP) Menstruation Disturbances Amenorrhea |
Estrogens Pathologic Processes Physiological Effects of Drugs |
Hormones, Hormone Substitutes, and Hormone Antagonists Hormones Pharmacologic Actions |