An interventional study of Transvaginal photobiomodulation and Sham therapy in Endometriosis, Dyspareunia and Pelvic Pain, sponsored by Medstar Health Research Institute. Terminated at 6 sites in United States. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-02-19.
Sponsored by Medstar Health Research Institute · Not applicable, Interventional, and Treatment
Among 168 studies in Endometriosis with a site in United States — 37 open to participants now, 47 under way, 5 of them phase 3. Endometriosis · United States.
Among the 168 studies in Endometriosis with a site in United States, this one is the 115th largest by enrollment of the 130 interventional ones that give a count, is one of 9 that started in 2023, is one of 38 with no phase, and was the 122nd registered.
920 studies on the registry are indexed under Endometriosis; 266 are open to participants now.
Browse Endometriosis studies →37 of the 168 studies in Endometriosis with a site in United States are open now. Recruiting first, the newest first:
Milton S. Hershey Medical Center · Sites in United States
LOAM Science · Sites in United States
Staci Gruber, Ph.D. · Sites in United States
Samphire Group, Inc. · Sites in United States
Vanderbilt University Medical Center · Sites in United States
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 176 Endometriosis studies recruiting now, 51 (29%) set no upper age limit and 123 (70%) stop at 75 or younger; 18 take children under 18; 39 take healthy volunteers.
This study: 18 Years and older · female · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
168 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 17 · Phase 2 45 · Phase 3 22 · Phase 4 14
First in 1998; this study’s year is marked. 9 started in 2023.
This study's enrollment of 6 is below the median of 67 across 540 interventional studies indexed under Endometriosis.
Median enrollment 60 across the 130 interventional studies, 187 across the 38 observational. Of the 102 that completed or were terminated, 50 (49%) have results posted.
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57 of 168 have an industry lead sponsor. The 10 most frequent:
Medstar Health Research Institute is the lead sponsor of 161 studies on the registry; 31 are open to participants now.
Of its 14 completed or terminated interventional studies of FDA-regulated products, 7 (50%) have results posted.
Medstar Health Research Institute has 1 study filed under Endometriosis — fewer than ten, so there is no comparison to draw.
20 of the studies in Endometriosis with a site in United States that are under way reach primary completion within a year, 2 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06375811Phase 3Yale UniversityPre-IVF Treatment With a GnRH Antagonist in Women With endometriosis_temp | 2027-03-31 |
| NCT04333576Phase 3AbbVieStudy Of Oral Elagolix Tablets In Combination With Combined Oral Contraceptive Capsules/Tablets To Assess Dysmenorrhea Response In Adult Female Participants With Endometriosis And Associated Moderate To Severe Pain | 2027-07 |
| NCT05245695Aspira Women's HealthDeep Neural Network Stratification for Use Detecting Endometriosis in Women Affected by Chronic Pelvic Pain (EndoCheck) | 2026-11-30 |
| NCT06477406Mclean HospitalEvaluating the Impact of a Novel Cannabinoid Product for Endometriosis | 2026-12 |
| NCT05059626Penn State UniversityEndometriosis and Microvascular Dysfunction; Simvastatin and Duavee | 2026-12-31 |
Among the 168 studies in Endometriosis with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
Active intervention: Transvaginal photobiomodulation (TV-PBM) Control intervention: Sham transvaginal probe
All subjects will complete 9 treatments over 3-4 weeks and all treatments will be performed with a sheet over the patient's pelvic area to prevent the subject from seeing the probe light, as well as a screen blocking the patient's view of the machine. Subjects randomized to active therapy will undergo TV-PBM treatment during each session per standard TV-PBM treatment protocol. Subjects randomized to sham will undergo blinded sham therapy using an identical probe but without photobiomodulation. Sham therapy will involve the same regimen as the active arm but with the machine turned off. Instead, there will be a recording of the usual noise of the machine to mimic the activation that occurs when stepping on the pedal with the machine on for TV-PBM treatment.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will undergo active transvaginal photobiomodulation therapy per clinic protocol, using the SoLa Pelvic Therapy system. This includes 9 treatments, each lasting about 3-5 minutes. A sterile narrow vaginal probe is inserted into the vagina, the low-level laser is activated, and the probe is slowly moved along the vaginal walls for the indicated period of time, via a surface area power calculation based on the measured vaginal length at the beginning of the procedure. The 9 treatments must be completed in 3-4 weeks. Intervention: Active SoLa Low-level laser therapy
Device: Transvaginal photobiomodulation
Participants will undergo sham transvaginal photobiomodulation therapy, following the same protocol as the active arm, without activation of the machine. This includes 9 treatments, lasting 3-5 minutes each. A sterile narrow vaginal probe is inserted into the vagina, the machine is NOT activated, and the inactive probe is slowly moved along the vaginal walls for 3-5 minutes. The 9 treatments must be completed in 3-4 weeks. Intervention: Mock treatment with inactivated probe
Device: Sham therapy
Low light laser therapy applied transvaginally using a small vaginal wand with sterile disposable wand covers. The intervention last 3-5 minutes based on a surface area calculation performed at the beginning of the intervention, and involves a gentle in and out motion of the wand to deliver light energy to the muscles of the pelvic floor.
Also known as: SoLa Pelvic Therapy
Use of the same vaginal wand as active arm, but without activation of the machine. The intervention last 3-5 minutes, and involves a gentle in and out motion of the wand to massage the muscles of the pelvic floor, without delivery of light therapy.
Mean change in pelvic pain
Defined by mean change in 10-point Numerical pain rating scale (NPRS) from baseline scores, compared between treatment and sham control arms
Time frame: Measured at baseline, after 4th treatment, 1-2 weeks after completion of treatment, and 6 weeks after completion of treatment
Change in Female Sexual Function Index (FSFI) scores
FSFI is a self-report questionnaire addressing six categories that contribute to female sexual satisfaction: desire, arousal, lubrication, orgasm, satisfaction, and pain.
Time frame: Measured at baseline, after 4th treatment, 1-2 weeks after completion of treatment, and 6 weeks after completion of treatment.
Change in Short Form-McGill Pain Questionnaire (SF-MPQ)
SF-MPQ is a self-reported questionnaire to help describe pain character and intensity. It consists of 15 descriptors (11 sensory; 4 affective) which are rated on an intensity scale as 0 = none, 1 = mild, 2 = moderate or 3 = severe. Three pain scores are derived from the sum of the intensity rank values of the words chosen for sensory, affective and total descriptors.
Time frame: Measured at baseline, after 4th treatment, 1-2 weeks after completion of treatment, and 6 weeks after completion of treatment.
Change in number of Sexually Satisfying Experiences (SSE)
A 2 question form asking number of SSEs in the past 7 days and the past 1 month. An SSE is defined as: a sexual experience in which you are satisfied with those factors that are most important to you. The experience can be with a partner or alone.
Time frame: Measured at baseline, after 4th treatment, 1-2 weeks after completion of treatment, and 6 weeks after completion of treatment.
Change in clinic pain scores
A standardized pelvic exam to evaluate each muscle group in abdomen and pelvis with a patient assigned pain score (0-10) to each area palpated.
Time frame: Measured at baseline, after 4th treatment, 1-2 weeks after completion of treatment, and 6 weeks after completion of treatment.
Plan to share: No
Ran from May 2023 to primary completion in Jun 2024, 13 months.
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This study is terminated, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.
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