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

NCT ID: NCT00152295

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

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-04-30

Study Completion Date

2001-12-31

Brief Summary

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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

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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 in Study M00-198. Pharmacodynamic effects to be assessed include uterine 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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Postmenopause

Keywords

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Postmenopausal Amenorrhea Hormone replacement therapy HRT asoprisnil Estrogen Replacement Therapy, postmenopause

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Group Type EXPERIMENTAL

Asoprisnil/Premarin

Intervention Type DRUG

10 mg (2-5mg tablets) asoprisnil and 0.625 mg Premarin tablets, oral daily for 6 months

Interventions

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Asoprisnil/Premarin

10 mg (2-5mg tablets) asoprisnil and 0.625 mg Premarin tablets, oral daily for 6 months

Intervention Type DRUG

Eligibility Criteria

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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.
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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M01-280

Identifier Type: -

Identifier Source: org_study_id