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Effect of Vaginal Estrogen on Asymptomatic Microhematuria (AMH)

NCT02213757 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 29

Last updated 2023-03-15

Study results available
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Summary

The purpose of this study is to determine if vaginal estrogen use is associated with resolution of blood in the urine (microscopic hematuria) in postmenopausal women. The hypothesis is that postmenopausal women with blood in the urine (microscopic hematuria) will have higher rates of resolution of hematuria after treatment course with vaginal conjugated equine estrogen cream compared to placebo cream

Conditions

  • Microscopic Hematuria

Interventions

DRUG

Premarin vaginal estrogen cream

DRUG

Placebo vaginal cream

Inactive vaginal cream manufactured to mimic Premarin vaginal cream

Sponsors & Collaborators

  • Pfizer

    collaborator INDUSTRY

  • Medstar Health Research Institute

    lead OTHER

Principal Investigators

  • Cheryl B Iglesia, MD · Medstar Health Research Institute

  • Lee A Richter, MD · Medstar Health Research Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-08-31
Primary Completion
2015-12-31
Completion
2015-12-31

Countries

  • United States

Study Locations

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Entities

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 NCT02213757 on ClinicalTrials.gov