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Trial of Vaginal Estrogen for Urogenital Symptom Relief in Women on Aromatase Inhibitors

NCT02528383 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2017-09-18

No results posted yet for this study

Summary

Vagifem, is the most appropriate medication to treat bladder and vaginal symptoms such as vaginal dryness and urinary discomfort. The purpose of this research study is to see the benefit this three month vaginal estrogen tablet, Vagifem, has on the bladder, vaginal symptoms and health. The investigators also want to monitor whether the bones might be impacted by estrogen or its absence. If there is an effect on bones, it means that some estrogen may be absorbed from the tablet to affect other places in the body. The investigators are hoping to prove this is not the case. The investigators will also be measuring the quality of life of women participating in the study.

Conditions

Interventions

BEHAVIORAL

Vagifem

Women participating in the study will undergo clinical assessments, blood work and complete the quality of life questionnaire at baseline, 6 weeks and 12 weeks study time points. The following will be assessed: 1. Effect of low dose Vagifem, 10ug tablet on vaginal atrophy. 2. Effect of low dose Vagifem, 10ug tablet on sex hormones and bone health biomarkers. 3. Impact of treatment on quality of life

Sponsors & Collaborators

  • Connecticut Breast Health Initiative

    collaborator OTHER

  • Susan Tannenbaum

    lead OTHER

Principal Investigators

  • Susan Tannenbaum, MD · UConn Health

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-08-31
Primary Completion
2017-05-31
Completion
2017-05-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT02528383 on ClinicalTrials.gov