CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 61 enrolled
Drug / intervention
estriol +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02413008
NCT02413008Phase 2Completed
CompareCT.gov

A Phase II Prospective, Randomized, Double-Blind, Placebo-Controlled and Multi-Centre Clinical Trial to Assess the Safety of 0.005 % Estriol Vaginal Gel in Hormone Receptor-Positive Postmenopausal Women With Early Stage Breast Cancer in Treatment With Aromatase Inhibitor in the Adjuvant Setting

ITF Research Pharma, S.L.U.·interventional·Posted Apr 9, 2015·Updated Aug 5, 2019

In Brief

A Phase 2 clinical trial evaluating estriol and Placebo for Vaginal Atrophy. Completed, enrolled 61 participants across 6 sites in 2 countries.

Detailed Summary

This is a phase II, prospective, randomized, double-blind, placebo-controlled, international (Spain and Sweden) and multicentre study to explore the safety of 0.005% estriol vaginal gel in women with early stage breast cancer in treatment with Non-Steroidal Aromatase Inhibitors (NSAIs) in the adjuvant setting and symptoms of vaginal atrophy.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsVaginal Atrophy
CountriesSpain, Sweden
CollaboratorsSpanish Breast Cancer Research Group

Timeline

Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
First PostedApr 9, 2015
Enrollment StartOct 16, 2015
Primary CompletionFeb 10, 2017
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 11.2 years ago

Interventions

estrioldrug

0.005% estriol vaginal gel

Placebodrug

placebo vaginal gel