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Study to Determine Efficacy & Safety of a Low Concentration Estriol (0.005%) in Postmenopausal Vaginal Atrophy.

NCT04574999 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 167

Last updated 2020-12-11

Study results available
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Summary

Randomized, double-blind, placebo-controlled multicentre study, with parallel groups, to determine the efficacy and safety of a new low-concentration estriol formulation (ITFE-2026 0.005%) for application by vaginal route in the treatment of postmenopausal vaginal atrophy.

Primary objective:

• To evaluate the efficacy of 0.005% Estriol vaginal gel by evaluation of the change in the maturation value of the vaginal epithelium (MV) after 12 weeks of treatment.

Secondary objectives:

* To determine the variation of the vaginal pH, as well as symptoms and signs suggestive of vaginal atrophy after 12 weeks of treatment.
* To study the variation of the MV, pH and symptoms and signs suggestive of vaginal atrophy after an initial observation period of 3 weeks.
* To evaluate the safety of 0.005% Estriol vaginal gel
* To evaluate the acceptability of 0.005% Estriol vaginal gel

Conditions

  • Vaginal Atrophy

Interventions

DRUG

Estriol

Gel for vaginal application

OTHER

Placebo

Gel for vaginal application

Sponsors & Collaborators

  • Italfarmaco S.A

    lead INDUSTRY

Principal Investigators

  • Javier Ferrer Barriendos, MD, PhD · Hospital Universitario Central de Asturias

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-01-25
Primary Completion
2009-02-23
Completion
2009-02-23
FDA Drug
Yes

Countries

  • Spain

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 NCT04574999 on ClinicalTrials.gov