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Safety/Efficacy of Q-122 in Breast Cancer Patients Taking Tamoxifen or Aromatase Inhibitor

NCT03518138 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 132

Last updated 2021-07-23

No results posted yet for this study

Summary

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. 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.

Conditions

  • Vasomotor Symptoms (VMS)

Interventions

DRUG

Q-122

oral capsule of Q-122

DRUG

Placebo

oral capsule of placebo

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2018-10-24
Primary Completion
2020-07-29
Completion
2020-09-09
FDA Drug
Yes

Countries

  • United States
  • Australia
  • New Zealand

Study Locations

More Related Trials

Entities

Drugs
Companies

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 NCT03518138 on ClinicalTrials.gov