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

Study on Investigational Medication for Vasomotor Symptoms

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 19 Feb 2024. Study ID: 1811516291 (Q122-2001)

This study investigates the effectiveness of an investigational medication for treating Vasomotor Symptoms (VMS), which are hot flashes, compared to a placebo. Participants will be randomly assigned to one of two study arms: one receiving the investigational medication and the other receiving a placebo.

During the study, participants will take either the investigational medication or a placebo for 28 days. After this period, there will be a 2-week follow-up without any medication to monitor symptoms before the study ends. A placebo is an inactive substance that looks like the investigational medication but does not contain any medicine.

  • Who can participate: Adults with a history of or current breast cancer who are taking tamoxifen or an aromatase inhibitor can participate. They must experience at least 50 moderate to severe hot flashes per week. Eligibility is determined after a screening period.
  • Study details: Participants will take either the investigational medication or a placebo daily for 28 days. After this, there will be a 2-week period without any medication to observe changes in symptoms. A placebo is an inactive substance that looks like the investigational medication but does not contain any medicine.

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