At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 88 enrolled
Drug / intervention
Promensil +1 moredrug
Likely dose
Promensil 80 mgfrom 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.
RED CLOVER EXTRACT (PROMENSIL) AND LIFESTYLE CHANGES TO CONTRAST MENOPAUSAL SYMPTOMS IN PREMENOPAUSAL WOMEN WITH HORMONE-SENSITIVE BREAST CANCER RECEIVING ADJUVANT ANTI-ESTROGEN THERAPY
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano·interventional·Posted Feb 18, 2019·Updated Feb 20, 2019
In Brief
A Phase 2 clinical trial evaluating Promensil and Placebo Oral Tablet for Breast Cancer. Completed, enrolled 88 participants across 1 site.
Detailed Summary
A prospective double-blind randomized trial of red clover extract (Promensil) vs placebo in surgically-treated premenopausal women with estrogen receptor-positive breast cancer taking tamoxifen
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer
CountriesItaly
Collaborators--
Timeline
Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
Enrollment StartJul 2012
Primary CompletionMar 2014
Study CompletionFeb 2016
First PostedFeb 2019
TodayJul 2026
First PostedFeb 18, 2019
Enrollment StartJul 5, 2012
Primary CompletionMar 25, 2014
Study CompletionFeb 23, 2016
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 7.4 years ago
Interventions
Promensildrug
1 tablet (80 mg) /day of MCE-11 (Promensil) taken orally for 24 months
Placebo Oral Tabletdrug
Placebo tablet (80 mg) (without active principle) given once a day for 24 months