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

Recruiting
18 years - 70 years
Female
1 Location

Brief description of study

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.

Detailed description of study

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 of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Vasomotor Symptoms,Breast Cancer
  • Age: 18 years - 70 years
  • 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.

Updated on 04 Aug 2024. Study ID: 1811516291 (Q122-2001)

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