CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 150 enrolled
Drug / intervention
Oxybutynin Chloride +3 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02961790
NCT02961790Phase 3Completed
CompareCT.gov

A Phase III, Double-Blind, Controlled Trial of Oxybutynin in the Management of Hot Flashes

Academic and Community Cancer Research United·interventional·Posted Nov 11, 2016·Updated Jan 18, 2020

In Brief

A Phase 3 clinical trial evaluating Oxybutynin Chloride, Placebo, and 2 other interventions for Breast Carcinoma and 4 related conditions. Completed, enrolled 150 participants across 13 sites.

Detailed Summary

This randomized phase III trial studies how well oxybutynin chloride works in managing hot flashes in patients who are not candidates for, or not interested in hormone replacement therapy. Previous studies have shown that oxybutynin is effective in managing hot flashes, however doses used in prior studies have resulted in side effects. This trial is evaluating lower doses of oxybutynin with the goal of determining if they are efficacious with less side effects. ADAM-VTE

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Carcinoma, Ductal Breast Carcinoma In Situ, Hot Flashes, Lobular Breast Carcinoma In Situ, No Evidence of Disease
CountriesUnited States
CollaboratorsNational Cancer Institute (NCI)

Timeline

Phase 3CompletedFinished
2017201820192020202120222023202420252026
First PostedNov 11, 2016
Enrollment StartDec 9, 2016
Primary CompletionApr 27, 2018
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 9.6 years ago

Interventions

Oxybutynin Chloridedrug

Given PO

Placeboother

Given PO

Quality-of-Life Assessmentother

Ancillary studies

Questionnaire Administrationother

Ancillary studies