A Long-Term Study to Evaluate the Safety of Asoprisnil and Estrogen Administration to Postmenopausal Women

• Status: Completed
• Trial end date: 2001-12-01
• Target enrollment: 0
• Participant gender: Female

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Abbott
• Treatments: Estrogens; Estrogens, Conjugated (USP)

Criteria

Inclusion Criteria:

• Successful completion of study M00-198

• Continued good general health

• Negative urine pregnancy test

Exclusion Criteria:

• 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.