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

NCT ID: NCT00152282

Last Updated: 2008-05-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

105 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-09-30

Study Completion Date

2001-08-31

Brief Summary

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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

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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

Conditions

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Amenorrhea Postmenopause

Keywords

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Postmenopausal Amenorrhea Hormone replacement therapy HRT asoprisnil

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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1

Group Type EXPERIMENTAL

Asoprisnil/Premarin

Intervention Type DRUG

Asoprisnil 5mg and Premarin 0.625 mg Tablets, oral Daily for 12 weeks

2

Group Type EXPERIMENTAL

Asoprisnil/Premarin

Intervention Type DRUG

Asoprisnil 10mg and Premarin 0.625 mg Tablets, oral Daily for 12 weeks

3

Group Type EXPERIMENTAL

Asoprisnil/Premarin

Intervention Type DRUG

Asoprisnil 25mg and Premarin 0.625 mg Tablets, oral Daily for 12 weeks

4

Group Type PLACEBO_COMPARATOR

Placebo and Premarin

Intervention Type DRUG

Placebo and Premarin 0.625 mg Tablets, oral Daily for 12 weeks

Interventions

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Asoprisnil/Premarin

Asoprisnil 5mg and Premarin 0.625 mg Tablets, oral Daily for 12 weeks

Intervention Type DRUG

Asoprisnil/Premarin

Asoprisnil 10mg and Premarin 0.625 mg Tablets, oral Daily for 12 weeks

Intervention Type DRUG

Asoprisnil/Premarin

Asoprisnil 25mg and Premarin 0.625 mg Tablets, oral Daily for 12 weeks

Intervention Type DRUG

Placebo and Premarin

Placebo and Premarin 0.625 mg Tablets, oral Daily for 12 weeks

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

48 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Abbott

INDUSTRY

Sponsor Role lead

Responsible Party

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Abbott

Principal Investigators

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Medical Director

Role: STUDY_CHAIR

Abbott

Other Identifiers

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M00-198

Identifier Type: -

Identifier Source: org_study_id