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A Trial to Evaluate the Efficacy of Low Dose Vaginal Estrogens in the Treatment of Atrophic Vaginitis

NCT00816556 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 63

Last updated 2017-11-13

Study results available
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Summary

Atrophic vaginitis is a common problem that occurs in up to 40% of postmenopausal women. The main symptoms are dryness, itching and burning in and around the vagina. These symptoms in turn can cause pain with intercourse. Other symptoms can include urinary frequency and urinary urgency. These symptoms are caused by the decreasing levels of estrogens in postmenopausal women.

The current treatment options include hormone replacement therapy by mouth and patch and vaginal creams, tablets and rings. The current guideline recommend using hormone therapy at the lowest dose for the shortest time. We are trying to find the lowest effective dose of estrogen cream that helps with symptoms without causing an increase in estrogens in the blood stream.

We want to compare two estrogen creams, estradiol and estriol, each at very low doses, with a placebo cream. Estradiol cream is available on prescription but we want to see how effective it is at one tenth the commonly prescribed dose. Estriol cream is not commonly prescribed and is only available at compounding pharmacies. We want to see if either of these estrogens is effective at one tenth the usual dose. We also want to see if these creams are effective when massaged onto the outer part of the vagina, rather than the usual method of treatment, which is inserting them into the vagina.

Conditions

  • Atrophic Vaginitis

Interventions

DRUG

Estriol

Estriol 10 micrograms added to Vanicream Lite 0.5 grams applied to vaginal introitus daily for 2 weeks and then twice weekly for 10 weeks.

DRUG

Estradiol valerate

Estradiol valerate 10 micrograms added to Vanicream Lite 0.5 grams applied to vaginal introitus daily for two weeks and then twice weekly for 10 weeks

DRUG

Vanicream Lite

Vanicream Lite 0.5 grams applied to vaginal introitus daily for two weeks and then twice weekly for 10 weeks

Sponsors & Collaborators

  • National Center for Advancing Translational Sciences (NCATS)

    collaborator NIH

  • Maire Mac Bride

    lead OTHER

Principal Investigators

  • Maire B Mac Bride, MB BCh · Mayo Clinic

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2008-10-31
Primary Completion
2011-09-30
Completion
2011-12-31

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 NCT00816556 on ClinicalTrials.gov