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

Phase 2

Completed

• Conditions: Amenorrhea; Postmenopause
• Interventions: Drug: Asoprisnil/Premarin; Drug: Placebo and Premarin

• Registration Number: NCT00152282
• Lead Sponsor: Abbott

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 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

Study Timeline

• Study Start: 2000-09
• Primary Completion: 2001-08
• Study Completion: 2001-08
• Study First Submitted: 2005-09-07
• Study First Submitted QC: 2005-09-07
• Study First Posted: 2005-09-09
• Status Verified: 2008-05
• Last Update Submitted: 2008-05-27
• Last Update Posted: 2008-05-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 105

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Asoprisnil/Premarin	-
2	Asoprisnil/Premarin	-
3	Asoprisnil/Premarin	-
4	Placebo and Premarin	-

Primary Outcome Measures

Name	Time	Method
Assessment of endometrium by endometrial biopsy	Week 12
Change from baseline in endometrial thickness as assessed by ultrasound	Week 12

Secondary Outcome Measures

Name	Time	Method
Frequency and amount of vaginal bleeding via patient diary.	Week 4, 8, and 12
Incidence of hot flushes	Week 4, 8, and 12
Presence or absence of endometrial hyperplasia.	Week 12
Response to global efficacy question regarding improvement in menopause symptoms.	Week 12