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NCT06611501 · ClinicalTrials.gov registry record · Phase 2
Glycemic Regulation as Endometriosis Adjunct Treatment
A Phase 2 study of Endometriosis and Pelvic Pain, sponsored by Boston Children's Hospital.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 14
- Enrollment target
- 1
- Study location
NCT06611501: Recruiting Phase 2 study of Endometriosis and Pelvic Pain, sponsored by Boston Children's Hospital.
NCT06611501 is a Phase 2 study of Endometriosis and Pelvic Pain that is actively recruiting participants, run by Boston Children's Hospital. The registered enrollment target is 14 participants, below the 264-participant average among 48 other Endometriosis trials with a reported enrollment target (95% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06611501, a Phase 2 study of Endometriosis and Pelvic Pain, is actively recruiting participants, sponsored by Boston Children's Hospital.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 14 participants
- Enrollment target
- 1
- Study location
Study Summary
The goal of this pilot trial is to learn if a novel non-hormonal treatment, metformin hydrochloride, works to treat pelvic pain in young women with endometriosis. The main questions it aims to answer are: * Is metformin superior to placebo in alleviating pain symptoms in young women with endometriosis? * Does metformin alter systemic inflammatory markers over 6 months in young women with endometriosis? Researchers will compare metformin to a placebo (a look-alike substance that contains no drug) to see if metformin works to treat pelvic pain. Participants will: * Take drug metformin or a placebo every day for 6 months * Visit the clinic three times: once at baseline (pre-treatment), once at 3 months, and once at 6 months * Keep a daily symptom diary to track pain, bleeding, and usage of any pain medications
Primary Outcome
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 it
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Metformin Hydrochloride
Study Locations (1)
Massachusetts
- Boston Children's Hospital - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2025-05-22 |
| Est. Completion | 2027-01 |
| Phase | Phase 2 |
What NCT06611501 shows while recruiting
NCT06611501 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 14 participants, a relatively small participant target, below the 264-participant average among 48 other Endometriosis trials with a reported enrollment target (95% lower).
The record links to 2 conditions, with Endometriosis appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT06611501 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT06611501 about?
NCT06611501 is a clinical study titled "Glycemic Regulation as Endometriosis Adjunct Treatment". The goal of this pilot trial is to learn if a novel non-hormonal treatment, metformin hydrochloride, works to treat pelvic pain in young women with endometriosis. The main questions it aims to answer are: * Is metformin superior to placebo in alleviating pain symptoms in young women with endometrio...
What is the current status of trial NCT06611501?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 14 participants. The study started on 2025-05-22. Estimated completion is 2027-01.
What conditions does trial NCT06611501 study?
This clinical trial studies the following conditions: Endometriosis, Pelvic Pain.
What interventions are being tested in trial NCT06611501?
The interventions under investigation include: Placebo (DRUG), Metformin Hydrochloride (DRUG).
Who is sponsoring clinical trial NCT06611501?
This trial is sponsored by Boston Children's Hospital, which has 462 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06611501 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06611501's enrollment target sits among peer trials
14 48th of 48 higher than 1 of 48 other Endometriosis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Endometriosis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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