Glycemic Regulation as Endometriosis Adjunct Treatment

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Boston Children's Hospital
Study ID
NCT06611501
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
FEMALE
Age
15 Years - 35 Years
Healthy Volunteers
Not accepted

Interventions

  • Metformin Hydrochloride — DRUG
    Metformin dosage titrated from 500 mg/daily for 2 weeks, then 1000 mg/daily for 2 weeks, 1500 mg/daily for 2 weeks, and then achieving 2000 mg/daily for a duration of 6 months of treatment.
  • Placebo — DRUG
    1 tablet orally with evening meal for 2 weeks, then 1 tablet twice daily for 2 weeks, then 3 tablets split twice daily for 2 weeks, then 4 tablets split twice daily, for a total of 6 months of treatment.

Study Details

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

Key Dates

Start date
May 22, 2025
Status verified
Feb 2026
Primary completion
Jan 31, 2027
Completion
Jan 31, 2027

Study Design

Enrollment
14 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Placebo Comparator: Placebo
    Placebo tablets orally daily for a total of 6 months of treatment.
  • Experimental: Metformin
    metformin hydrochloride 500 mg capsules daily for a total of 6 months of treatment

Primary Outcome Measure

Change in pain assessed by the Brief Pain Inventory Interference Scale (BPI) over 6 months [ Time Frame: once at each of the three visits (at baseline, 3 months, 6 months) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Boston Children's HospitalBostonMassachusetts02115
Jessica Shim, MD
[email protected]
6173557648
Jessica Shim, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Boston, MA

By condition
Endometriosis
By specialty
Women's healthFertility
By research site
Boston Children's Hospital· Boston, MA

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