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Topical Estriol for Vaginal Health

NCT00908570 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 104

Last updated 2011-03-04

No results posted yet for this study

Summary

The purpose of this Phase I study is to investigate and document the effects of local treatment with a topical estriol cream on the vaginal environment of pre-menopausal women.

Conditions

  • Vaginal Health

Interventions

DRUG

estriol

4 ml vaginal cream (1.0 mg estriol/1 ml cream), 3 days/week for approximately 2 months.

DRUG

Placebo

Placebo cream

Sponsors & Collaborators

  • University of Illinois at Chicago

    collaborator OTHER

  • University of California, Los Angeles

    collaborator OTHER

  • Tulane University School of Medicine

    collaborator OTHER

  • Magee-Women's Research Institute

    collaborator OTHER

  • Oregon Health and Science University

    collaborator OTHER

  • Gynuity Health Projects

    lead OTHER

Principal Investigators

  • Yael Swica, M.D., M.P.H. · Gynuity Health Projects

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2009-06-30
Primary Completion
2011-03-31
Completion
2011-03-31

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

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 NCT00908570 on ClinicalTrials.gov