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Evaluation of the Acceptability and Efficacy of 10 Micrograms of Estradiol Vaginal Tablets vs Promestriene Vaginal Cream

NCT04232813 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2021-02-11

No results posted yet for this study

Summary

Evaluation of the Acceptability and Efficacy of 10 Micrograms of Estradiol Vaginal Tablets vs Promestriene Vaginal Cream in postmenopausal women aged 45 years or older, with one or more moderate to severe symptoms of vulvovaginal atrophy (dryness, dyspareunia, soreness or irritation).

Conditions

  • Vulvovaginal Atrophy

Interventions

DRUG

Estradiol 10 MCG Vaginal Tablet [VAGIFEM]

To insert the tablets the patient must use the applicator provided in the way explained in the prospectus.

DRUG

Promestriene Vaginal

To insert the cream the patient must use the applicator provided in the way explained in the prospectus.

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-01-09
Primary Completion
2020-06-30
Completion
2020-11-30

Countries

  • Spain

Study Locations

More Related Trials

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 NCT04232813 on ClinicalTrials.gov