TerminatedNot Applicable

Transvaginal Low-level Laser Therapy to Improve Pelvic Pain and Sexual Function in Patients with Endometriosis.

Stopped: Study unable to be conducted with resources at site.

United States6 participantsStarted 2023-05-02

Plain-language summary

Dyspareunia is defined as pain with penetrative sexual intercourse. Women with endometriosis have a nine-fold increased risk of dyspareunia, when compared to the general female population. A prospective single-blinded randomized controlled trial will be performed evaluating the change in pelvic pain and sexual satisfaction scores from baseline to 6 weeks after treatment with transvaginal photobiomodulation therapy or sham therapy. Treatment will involve 9 planned treatment sessions over 3-4 weeks. 40 women will be included in the study.

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: * Proficient English-speaking females * Pathology proven endometriosis, \>6 weeks from prior pelvic surgery * Current dyspareunia Exclusion Criteria: * Unable to comply with study protocol * Pregnant or attempting to become pregnant * History of or active treatment for pelvic malignancy * Currently taking light-sensitizing drugs

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

Mean change in pelvic pain

Timeframe: Measured at baseline, after 4th treatment, 1-2 weeks after completion of treatment, and 6 weeks after completion of treatment

Trial details

NCT IDNCT05540353

SponsorMedstar Health Research Institute

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-06-30

View on ClinicalTrials.gov More Endometriosis trials