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

NCT00152282 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 105

Last updated 2008-05-29

No results posted yet for this study

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.

Conditions

  • Amenorrhea
  • Postmenopause

Interventions

DRUG

Asoprisnil/Premarin

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

DRUG

Asoprisnil/Premarin

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

DRUG

Asoprisnil/Premarin

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

DRUG

Placebo and Premarin

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

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Abbott

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
48 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2000-09-30
Primary Completion
2001-08-31
Completion
2001-08-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00152282 on ClinicalTrials.gov