Use of Rosiglitazone in the Treatment of Endometriosis
Treatment of Endometriosis Pain With Rosiglitazone: A Prospective Phase 2 Clinical Trial
Sponsor: Berlex Foundation
Terminated
Due to the meta-analysis about CV adverse effects of rosiglitazone.
Listed as NCT00115661, this PHASE2 trial focuses on Endometriosis and remains terminated or withdrawn. Sponsored by Berlex Foundation, it has been updated 6 times since 2005, reflecting limited change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.
Study Description(click to expand)There is no current pain control in women with minimal-mild endometriosis that concomitantly allows them the chance to conceive. Women between the ages of 18 and 45 years with minimal to mild endometriosis and pelvic pain of greater than three months duration, will be enrolled into a 6-month prospective phase 2 clinical trial.
Comparison: Following enrollment, one week after the last menstrual period, eligible participants will be randomized to a 6-month treatment of rosiglitazone 4 mg/day. Efficacy comparisons will be made utilizing visual analog scale diaries, Short-Form McGill Pain Questionnaires and physical component summary scores of the SF-36. Secondary measures will include cytokine quantification, proteomics, gene array analyses and serious adverse effects.
There is no current pain control in women with minimal-mild endometriosis that concomitantly allows them the chance to conceive. Women between the ages of 18 and 45 years with minimal to mild endometriosis and pelvic pain of greater than three months duration, will be enrolled into a 6-month prospective phase 2 clinical trial.
Comparison: Following enrollment, one week after the last menstrual period, eligible participants will be randomized to a 6-month treatment of rosiglitazone 4 mg/day. Efficacy comparisons will be made utilizing visual analog scale diaries, Short-Form McGill Pain Questionnaires and physical component summary scores of the SF-36. Secondary measures will include cytokine quantification, proteomics, gene array analyses and serious adverse effects.
Status Flow
Change History
6 versions recorded-
Sep 2024 — Present [monthly]
Terminated PHASE2
-
Jul 2024 — Sep 2024 [monthly]
Terminated PHASE2
-
Jan 2021 — Jul 2024 [monthly]
Terminated PHASE2
-
Jun 2018 — Jan 2021 [monthly]
Terminated PHASE2
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Feb 2017 — Jun 2018 [monthly]
Terminated PHASE2
▶ Show 1 earlier version
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Jan 2017 — Feb 2017 [monthly]
Terminated PHASE2
First recorded
Jul 2005
Trial started
Per CT.gov start date — pre-dates our first snapshot
Eligibility Summary
No eligibility information available.
Contact Information
- Berlex Foundation
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
For direct contact, visit the study record on ClinicalTrials.gov .