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Hormone Replacement Therapy for Use in Postmenopausal Women for Relief of Hot Flushes and Urogenital Symptoms.

NCT01070979 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 249

Last updated 2013-04-22

Study results available
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Summary

Multicenter, double-blind, controlled, parallel group, randomized study to compare the clinical benefit of Estradiol acetate tablets, estradiol tablets and conjugated equine estrogen tablets, each administered orally, once daily, to postmenopausal women.

Conditions

  • Hormone Replacement Therapy

Interventions

DRUG

Estradiol acetate

Tablet containing 0.9 mg E3A, daily oral administration.

DRUG

Estradiol

Tablet containing 1 mg estradiol, daily oral administration.

DRUG

Conjugated equine estrogens

Tablet containing 0.625 mg CEE, daily oral administration.

Sponsors & Collaborators

  • Warner Chilcott

    lead INDUSTRY

Principal Investigators

  • Herman Ellman, MD · Warner Chilcott

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
35 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-02-28
Primary Completion
2003-09-30
Completion
2003-09-30

Countries

  • United States

Study Locations

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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 NCT01070979 on ClinicalTrials.gov