A Study to Evaluate the Safety and Effectiveness of Asoprisnil and Estrogen Administration to Postmenopausal Women

• Status: Completed
• Trial end date: 2001-08-01
• Target enrollment: 0
• Participant gender: Female

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.

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

Details

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

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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