Transvaginal Low-level Laser Therapy to Improve Pelvic Pain and Sexual Function in Patients with Endometriosis.
Stopped early · Not applicable · Has a placebo group
Conditions studied: Endometriosis, Dyspareunia, Pelvic Pain
In brief
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.
Key facts
- Study ID
- NCT05540353
- Run by
- Medstar Health Research Institute
- People needed
- 6
- Starts
- 2023-05-02
- Expected to finish
- 2024-07-01
- Last updated by the study team
- 2025-02-19
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- Proficient English-speaking females
- Pathology proven endometriosis, >6 weeks from prior pelvic surgery
- Current dyspareunia
You may not qualify if…
- 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
Where it is running
- MedStar Washington Hospital Center — Washington D.C., District of Columbia, United States
- MedStar Lafayette Center — Washington D.C., District of Columbia, United States
- MedStar Georgetown University Hospital — Washington D.C., District of Columbia, United States
- MedStar Mitchellville Clinic — Mitchellville, Maryland, United States
- MedStar Rockville Clinic — Rockville, Maryland, United States
- MedStar McLean Clinic — McLean, Virginia, United States
Full record on ClinicalTrials.gov
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