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Red Clover and Lifestyle Changes to Contrast Menopausal Symptoms in Premenopausal Breast Cancer Patients Given Tamoxifen

NCT03844685 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 88

Last updated 2019-02-20

No results posted yet for this study

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

Conditions

Interventions

DRUG

Promensil

1 tablet (80 mg) /day of MCE-11 (Promensil) taken orally for 24 months

DRUG

Placebo Oral Tablet

Placebo tablet (80 mg) (without active principle) given once a day for 24 months

Sponsors & Collaborators

  • Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-07-05
Primary Completion
2014-03-25
Completion
2016-02-23

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

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 NCT03844685 on ClinicalTrials.gov