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A Clinical Study to Evaluate the Effects of Estrogen in Healthy Postmenopausal Women

NCT00820664 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 29

Last updated 2016-01-22

Study results available
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Summary

The purpose of this study is to examine the effect of two different dose levels of estrogen or placebo in healthy postmenopausal women by measuring the changes in hormone levels and examining the changes in the uterine lining (endometrium).

Conditions

  • Postmenopausal Symptoms

Interventions

DRUG

Comparator: Estrace 0.5 mg

0.5 mg tablet taken once daily for 28 days

DRUG

Comparator: Estrace 2 mg

2 mg tablets taken once daily for 28 days.

DRUG

Comparator: Placebo

Placebo 0 mg capsule taken once daily for 28 days

Sponsors & Collaborators

Principal Investigators

  • Medical Monitor · Merck Sharp & Dohme LLC

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-12-31
Primary Completion
2009-05-31
Completion
2009-05-31

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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 NCT00820664 on ClinicalTrials.gov