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Use of Estriol at Distal Third of Vagina Improving Coital Pain in Post-menopause Women

NCT03116022 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 125

Last updated 2024-10-16

No results posted yet for this study

Summary

Hypoestrogenism leads to vaginal wall changes resulting in diminished vaginal lubrication and, consequently, causing pain during intercourse. Topical estrogen therapy (THT) may control this complaint. However, there are limitations on its use, especially in patients with breast cancer and diagnosed endometrial cancer. This randomized clinical trial aims to assess the impact of local estriol therapy in postmenopausal women complaining of coital pain and to assess serum concentrations of estriol in these women after estriol use. One-hundred-thirty-two women aged between 40 and 65 years will be randomized into three groups: Women using estriol 1 mg / 1g at the proximal third of vagina every other night - estriol proximal group (PEG), women in using estriol 1 mg / 1g at the distal third of the vagina every other night - estriol distal group (DEG), gel group (GG) using water-based during intercourse.

Conditions

Interventions

DRUG

Estriol

Women using drug 1 mg / 1g in the proximal third of the vagina every other night for 12 weeks

DRUG

Distal estriol

Women using drug 1 mg / 1g at the distal third of the vagina every other night for 12 weeks

DRUG

Vaginal Gel

Women using a base water gel lubricant during intercourse

Sponsors & Collaborators

  • University of Sao Paulo

    lead OTHER

Principal Investigators

  • lucia a Silva Lara, PhD · Faculdade de Medicina de Ribeirão Preto - Universidade de Sao Paulo

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2017-06-01
Primary Completion
2018-12-31
Completion
2024-01-31

Countries

  • Brazil

Study Locations

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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 NCT03116022 on ClinicalTrials.gov