Status:
COMPLETED
A Long-Term Study to Evaluate the Safety of Asoprisnil and Estrogen Administration to Postmenopausal Women
Lead Sponsor:
Abbott
Conditions:
Postmenopause
Eligibility:
FEMALE
48-65 years
Phase:
PHASE2
Brief Summary
The objective of this study is to determine the long-term safety of asoprisnil 10 mg when administered to postmenopausal women with Premarin® 0.625 mg
Detailed Description
The objective of this study is to determine the long-term safety of asoprisnil 10 mg (2-5mg tablets) when taken with Premarin® 0.625 mg, by postmenopausal women, for 6 months after an initial 12 weeks...
Eligibility Criteria
Inclusion
- Successful completion of study M00-198
- Continued good general health
- Negative urine pregnancy test
Exclusion
- History of known or suspected cancer other than basal cell carcinoma in last 5 years
- History of reproductive endocrine disorder
- Submucous or other symptomatic fibroid which would confound efficacy
- Ovarian mass
- Ongoing treatment with an excluded medication
- Stenosis of the cervix
- Any abnormal lab result the study-doctor considers significant.
Key Trial Info
Start Date :
April 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2001
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT00152295
Start Date
April 1 2001
End Date
December 1 2001
Last Update
May 29 2008
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