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N/A

Vaginal Dilator Therapy for Painful Intercourse

N/A
Waitlist Available
Led By Jason D. Wright, MD
Research Sponsored by Columbia University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients currently or previously treated for gynecologic cancer (surgery, chemotherapy, adjuvant vaginal brachytherapy)
Patients currently or previously treated for breast cancer (chemotherapy, aromatase inhibitors, or selective estrogen receptor modulators; surgical menopause)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 16 weeks
Awards & highlights

Study Summary

This trial will compare whether using a vaginal dilator with moisturizer improves pain and sexual function for women with cancer who have pain during sex.

Who is the study for?
This trial is for women 18 or older with gynecologic or breast cancers who experience painful intercourse and want to engage in penetrative sexual activity. They must be able to use a vaginal dilator themselves, understand and sign consent, and not have had pelvic radiation, vulvodynia with high pain scores, prior dilator use, chronic pelvic pain, or upfront pelvic radiation.Check my eligibility
What is being tested?
The study compares the effectiveness of using both a vaginal dilator with moisturizer versus just moisturizer alone in reducing pain during intercourse over 16 weeks. It involves randomly assigning participants into two groups: one receiving both treatments (Intervention Group) and one receiving only the moisturizer (Control Group).See study design
What are the potential side effects?
Potential side effects may include discomfort or pain from using the vaginal dilator, possible irritation from the moisturizer, emotional distress due to discussing intimate details related to sexual function.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been treated for a cancer that affects women's reproductive organs.
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I have been treated for breast cancer before.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 16 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 16 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Difference in Mean Patient-Reported Pain Scores During Sexual Activity
Secondary outcome measures
Difference in Mean Patient-Reported Pain Scores During Speculum Exam
Other outcome measures
Sexual Function based on the PROMIS SexFS Score (Version 2.0)

Trial Design

2Treatment groups
Experimental Treatment
Group I: Vaginal Dilator InterventionExperimental Treatment2 Interventions
Patients assigned to the vaginal dilator group will be provided the device, vaginal moisturizer, an adherence calendar, and standardized verbal and written instructions from a trained health professional to apply the moisturizer and use the dilator for 15 minutes daily. Standard medical grade vaginal dilators and pure Vitamin E oil will be provided for each study participant. They have the option of purchasing a dilator and/or moisturizer of a similar nature if they choose to.
Group II: Control (Vaginal Moisturizer Only)Experimental Treatment1 Intervention
Patients assigned to vaginal moisturizer alone will receive pure Vitamin E oil and similar standardized instructions on daily use and an adherence calendar. They will apply a dime-sized amount of Vitamin E oil every day. They have the option of purchasing their own moisturizer if they choose to.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Vaginal Dilator
2008
N/A
~180

Find a Location

Who is running the clinical trial?

Columbia UniversityLead Sponsor
1,431 Previous Clinical Trials
2,460,831 Total Patients Enrolled
Jason D. Wright, MDPrincipal InvestigatorColumbia University

Media Library

Vaginal Dilator Therapy (N/A) Clinical Trial Eligibility Overview. Trial Name: NCT05129332 — N/A
Painful Intercourse Research Study Groups: Control (Vaginal Moisturizer Only), Vaginal Dilator Intervention
Painful Intercourse Clinical Trial 2023: Vaginal Dilator Therapy Highlights & Side Effects. Trial Name: NCT05129332 — N/A
Vaginal Dilator Therapy (N/A) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05129332 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any vacancies for the trial open to participants?

"Evidently, this trial is now closed for patient recruitment. Posting on April 1st 2022 and last updated on March 7th 2022, no further enrolment can occur; however, 10 other trials are presently welcoming participants."

Answered by AI

Who else is applying?

What state do they live in?
Wisconsin
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
Vaginal Dilator Therapy Among Women With Gynecologic and Breast Cancers Experiencing Dyspareunia
Jason D. Wright 2022. "Vaginal Dilator Therapy Among Women With Gynecologic and Breast Cancers Experiencing Dyspareunia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05129332.
~0 spots leftby Apr 2025
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