Status:
COMPLETED
A Study to Evaluate the Safety and Effectiveness of Asoprisnil and Estrogen Administration to Postmenopausal Women
Lead Sponsor:
Abbott
Conditions:
Amenorrhea
Postmenopause
Eligibility:
FEMALE
48-65 years
Phase:
PHASE2
Brief Summary
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.
Detailed Description
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...
Eligibility Criteria
Inclusion
- Postmenopausal women with an intact uterus
- Body mass index (BMI) between 18.0 - 33.0
- Good general health
- Endometrial thickness ≤ 4 mm by TVU
- No history or suspected endometrial hyperplasia
- Negative urine pregnancy test
- Pap smear in last 6 months with no evidence of malignancy or pre-malignant changes
- Mammogram without suspicion of malignancy within last 6 months
- Endometrial biopsy with no evidence of pathologic changes within last 6 months
Exclusion
- Any abnormal lab result the study-doctor considers significant
- History of severe reaction to hormone therapy
- Receiving hormone therapy
- Currently using phytoestrogenic compounds, such as red clover, black cohosh (Promensil and Remifemin), dong quai, ginseng and soy isoflavones
- History or known or suspected cancer other than basal cell carcinoma
- Stenosis of the cervix
- History of reproductive endocrine disorder
- Washout requirement for hormonal therapy not met
- Ovarian mass
- Submucus or other symptomatic fibroid which would confound efficacy
Key Trial Info
Start Date :
September 1 2000
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2001
Estimated Enrollment :
105 Patients enrolled
Trial Details
Trial ID
NCT00152282
Start Date
September 1 2000
End Date
August 1 2001
Last Update
May 29 2008
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