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Ethinyl Estradiol and Norethindrone Acetate (Hormone Replacement Therapy) |
Femhrt |
Clinical Trial: A Study to Evaluate the Safety and Effectiveness of Asoprisnil and Estrogen Administration to Postmenopausal Women
This study has been completed.
|
Purpose
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 |
|---|---|---|
| Postmenopausal, hormone replacement therapy | Drug: Asoprisnil (J867) | Phase II |
MedlinePlus consumer health information
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, 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
Further Study Details:
Primary Outcomes: The percent of subjects in each endometrial biopsy diagnostic category, mean change from baseline to final visit in endometrial thickness, and cumulative rates and incremental incidence rate of vaginal bleeding (bleeding, spotting, and amenorrhea).
Secondary Outcomes: Secondary outcomes in this study will be percent of total bleeding days, mean number of moderate to severe hot flush, and mean weekly hot flush scores, etc.
Expected Total Enrollment: 100
Secondary Outcomes: Secondary outcomes in this study will be percent of total bleeding days, mean number of moderate to severe hot flush, and mean weekly hot flush scores, etc.
Expected Total Enrollment: 100
Study start: September 2000; Study completion: July 2003
Last follow-up: June 2001
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
Eligibility
Ages Eligible for Study: 48 Years and above, Genders Eligible for Study: Female
Criteria
Inclusion Criteria:
- Postmenopausal women with an intact uterus
- Body mass index (BMI) between 18.0 - 33.0
- Good general health
Exclusion Criteria:
- Any abnormal lab result the study-doctor considers significant
- History of severe reaction to hormone therapy
- Pap smear results indicating malignancy or premalignant changes
- Endometrial thickness over 4 mm or a history of endometrial hyperplasia
Location Information
Study chairs or principal investigators
Kristof Chwalisz, MD, PHD, Study Director, TAP Pharmaceutical Products
More Information
Study ID Numbers: M00-198
Last Updated: September 8, 2005
Record first received: September 7, 2005
ClinicalTrials.gov Identifier: NCT00152282
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-09-13
Last Updated: September 8, 2005
Record first received: September 7, 2005
ClinicalTrials.gov Identifier: NCT00152282
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-09-13
Resources
- Ethinyl Estradiol and Norethindrone Acetate (Hormone Replacement Therapy) (Drug Digest)
- Femhrt (Drug Digest)
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