A 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

PHASE2CompletedINTERVENTIONAL
Enrollment

61

Participants

Timeline

Start Date

October 16, 2015

Primary Completion Date

February 10, 2017

Study Completion Date

February 10, 2017

Conditions
Vaginal Atrophy
Interventions
DRUG

estriol

0.005% estriol vaginal gel

DRUG

Placebo

placebo vaginal gel

Trial Locations (6)

15006

For additional information regarding investigative sites for this trial, contact ITF Research Pharma S.L.U., A Coruña

23007

For additional information regarding investigative sites for this trial, contact ITF Research Pharma S.L.U., Jaén

28050

For additional information regarding investigative sites for this trial, contact ITF Research Pharma S.L.U., Madrid

46010

For additional information regarding investigative sites for this trial, contact ITF Research Pharma S.L.U., Valencia

08908

For additional information regarding investigative sites for this trial, contact ITF Research Pharma S.L.U., L'Hospitalet de Llobregat

171 77

For additional information regarding investigative sites for this trial, contact ITF Research Pharma S.L.U., Stockholm

All Listed Sponsors
collaborator

Spanish Breast Cancer Research Group

OTHER

lead

ITF Research Pharma, S.L.U.

INDUSTRY

NCT02413008 - A 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 | Biotech Hunter | Biotech Hunter