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Vaginal Dilator Therapy Among Women With Gynecologic and Breast Cancers Experiencing Dyspareunia

NCT05129332 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2024-04-04

No results posted yet for this study

Summary

In this randomized controlled trial, the investigators will assess the difference in mean patient-reported pain scores and sexual function between women with gynecologic or breast cancers experiencing dyspareunia (painful intercourse) who are assigned to vaginal dilator use with vaginal moisturizer (Intervention Group, n = 29) compared to vaginal moisturizer alone (Control Group, n = 29) over 16 weeks.

Conditions

  • Dyspareunia

Interventions

OTHER

Vaginal Moisturizer

Natural oil-based vaginal moisturizers, like Vitamin E Oil or Coconut Oil, will be applied topically (dime-size amount) on the labia externally and vagina internally nightly, but at least 3 times per week.

DEVICE

Vaginal Dilator

Vaginal dilator will be inserted vaginally and used daily, but at least 3 times per week.

Sponsors & Collaborators

Principal Investigators

  • Jason D. Wright, MD · Columbia University

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-08-03
Primary Completion
2024-02-07
Completion
2024-02-07
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

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 NCT05129332 on ClinicalTrials.gov