Trial · NCT06611501
Glycemic Regulation as Endometriosis Adjunct Treatment
NCT06611501, Phase 2, Active not recruiting, Boston Children's Hospital
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Glycemic Regulation as Endometriosis Adjunct Treatment. Trials, record NCT06611501. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06611501
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Glycemic Regulation as Endometriosis Adjunct Treatment
- NCT number
- NCT06611501
- Status
- Active not recruiting
- Phases
- Phase 2
- Enrollment
- 14 participants, estimated
- Lead sponsor
- Boston Children's Hospital
- Conditions
- Pelvic Pain, Endometriosis
- Interventions
- Metformin Hydrochloride, Placebo
- First posted
- 2024-09-25
- Last updated
- 2026-07-16
Source ClinicalTrials.gov
Registered outcomes25
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in pain assessed by the Brief Pain Inventory Interference Scale (BPI) over 6 months | once at each of the three visits (at baseline, 3 months, 6 months) | The BPI Interference Scale is a 7-item composite pain measurement. This self-report measure assesses the extent to which pain interferes with various components of physical and emotional functioning and sleep. The items in this scale can be grouped into those that assess physical functioning (general activity; walking ability; normal work, including both work outside the home and housework), those that assess emotional functioning (mood; relations with people; enjoyment of life), and a single item that assess the extent to which pain interferes with sleep. The arithmetic mean of the seven interference items can be used as a measure of pain interference. The BPI is anchored between a scale of zero (no pain/interference) to ten (maximum pain/interference). The magnitude of treatment-associated change in BPI Interference Scale scores in open-label and randomized clinical trials ranges from 1 to 3 points, depending on the specific pain conditions and treatments studied. |
| Primary | Change in pain severity measured by Visual Analog Scale (VAS) over 6 months | once at each of the three visits (at baseline, 3 months, 6 months) | VAS: A measurement of pain intensity, assessed by a 0 to 10 numerical rating scale, to rate maximum and average pain intensity over the preceding 7 days. Higher scores indicate more severe pain intensity. |
| Primary | Change in emotional functioning assessed by Beck Depression Inventory-II (BDI) over 6 months | once at each of the three visits (at baseline, 3 months, 6 months) | The BDI is a 21-item self-report instrument that provides a rapid assessment of depressive symptoms. BDI has been used in many studies of chronic pain, including chronic pelvic pain and endometriosis. Total scores on the BDI range from 0 to 63. The BDI takes about 5-10 minutes to complete. Scores below 13 should be considered to reflect "minimal or no" depression, with score ranges of 14 to 19, 20 to 28, and 29 to 63 reflect "mild to moderate," "moderate to severe," and "severe" depression, respectively. |
| Primary | Change in ratings of overall improvement assessed by the Patient Global Impression of Change scale (PGIC) | once at each of the three visits (at baseline, 3 months, 6 months) | The PGIC is a seven-point single-item scale with options ranging from 'very much worse' to 'very much improved'. There has been widespread use of the PGIC in recent endometriosis clinical trials, as it readily interprets a person's evaluation of the importance of their improvement or worsening. |
| Secondary | Change in quality of life, measured via Endometriosis Health Profile-30 (EHP-30) | once at each of the three visits (at baseline, 3 months, 6 months) | The EHP-30 is a reliable instrument and recommended by the American Society for Reproductive Medicine and the European Society for Human Reproduction and Embryology. The questionnaire includes 30 questions in five subcategories, with each category addressing specific problem areas of pain, control and powerlessness, emotional wellbeing, social support, and self-image. |
| Secondary | Changes in sexual satisfaction for participants who are sexually active measured by the New Sexual Satisfaction Scale | once at each of the three visits (at baseline, 3 months, 6 months) | The NSSS is a 20-item measure assessing sexual sensations, sexual presence/awareness, sexual exchange, emotional connection/closeness, and sexual activity. The full scale takes 5 minutes to complete. |
| Secondary | Complete health and medication history assessed by the World Endometriosis Research Foundation (WERF) questionnaire | once at each of the three visits (at baseline, 3 months, 6 months) | Study participants will complete an expanded version of the WERF questionnaire for a complete health and medication history |
| Secondary | Changes in serum angiogenic/inflammatory markers | once at each of the three visits (at baseline, 3 months, 6 months) | Serum samples will also be obtained for measures of inflammation, to test the hypothesis that endometriosis-relevant inflammatory markers will decrease over time in patients treated with metformin compared to those receiving placebo. These markers will include IL-6, IL-8, and VEGF based on the results of prior studies in which metformin appeared to reduce these levels in humans with endometriosis and from endometriotic implants in rats. C-reactive protein (CRP) will also be assessed; CRP has been shown to be upregulated, especially when examined with a high sensitivity assay making it possible to detect subclinical inflammation in women with endometriosis. |
| Other | Changes in school and/or work attendance | once at each of the three visits (at baseline, 3 months, 6 months) | School and/or work attendance will be assessed at each visit. |
| Other | Change in pregnancy status | once at each of the three visits (at baseline, 3 months, 6 months) | Urine pregnancy test throughout the study as current pregnancy is an exclusion criteria |
1 to 10 of 25Source ClinicalTrials.gov
See all 25 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers86
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT06611501
GET https://conductscience.org/api/trials/v1/NCT06611501/registered?page=2