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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
18-70 years
Female

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.
Study details
    Vasomotor Symptoms
    Breast Cancer

TX10163

19 February 2024

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