A Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of Q-122 for the Treatment of Vasomotor Symptoms in Female Breast Cancer Patients/Survivors Taking Tamoxifen or an Aromatase Inhibitor
Anna Maria Storniolo, MD
Primary Investigator
Overview
This is a Phase 2 proof-of-concept (POC) study designed to determine the effectiveness of Q-122 for the treatment of Vasomotor Symptoms (VMS) versus placebo.
Description
Participants who meet all eligibility criteria following the Screening/Run-In period will be randomized to 1 of 2 treatment arms; blinded Q-122 or placebo for a period of 28 days. All participants will be followed for a 2-week, drug-free, follow-up period after their last dose of blinded Q-122/placebo before termination from the study.
Eligibility
You may be eligible for this study if you meet the following criteria:
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Conditions:
Vasomotor Symptoms, Breast Cancer
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Age: Between 18 Years - 70 Years
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Gender: Female
Inclusion Criteria
In order to be eligible to take part in this trial, patients must meet the following criteria:
- Have a history of or current breast cancer and currently taking tamoxifen or an aromatase inhibitor.
- Experience an average of at least 50 moderate to severe hot flashes/week for the 2 weeks immediately preceding the Run-In Visit (i.e., during the Screening period).
For a full list of participation criteria, please visit clinicaltrials.gov.