Vaginal Dilator Therapy Among Women With Gynecologic and Breast Cancers Experiencing Dyspareunia (NCT05129332) | Clinical Trial Compass
WithdrawnNot Applicable
Vaginal Dilator Therapy Among Women With Gynecologic and Breast Cancers Experiencing Dyspareunia
Stopped: study was stopped as Fellow was unable to committ to enrollment and study due to time constraints
United States0Started 2022-08-03
Plain-language 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.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients 18 years or older
* English or Spanish speaking
* Patients currently or previously treated for:
* Gynecologic cancer (surgery, chemotherapy, adjuvant vaginal brachytherapy)
* Breast cancer (chemotherapy, aromatase inhibitors, or selective estrogen receptor modulators; surgical menopause)
* Current desire for penetrative sexual activity
* Endorsement of at least one of the following in the last 6 months:
* Dyspareunia during penetrative sexual activity
* Reported sensation of penetrative object (partner's penis, sex toy) not fitting in the vagina
* Avoidance of penetrative sexual activity due to fear of pain
* Physically able to insert a vaginal dilator by themselves
* Ability to understand and the willingness to sign a written informed consent document
Exclusion Criteria:
* Patients with prior primary or upfront pelvic radiation
* Patients with whole pelvic radiation at any time
* Patients with a history of chronic pelvic pain
* Patients with vulvodynia as noted on baseline pelvic exam with \> 5/10 pain score during an external exam with a cotton swab
* Patients with prior vaginal dilator use for any indication
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Difference in Mean Patient-Reported Pain Scores During Sexual Activity