deltatrials
Terminated PHASE2 INTERVENTIONAL NCT00115661

Use of Rosiglitazone in the Treatment of Endometriosis

Treatment of Endometriosis Pain With Rosiglitazone: A Prospective Phase 2 Clinical Trial

Sponsor: Berlex Foundation

Conditions Endometriosis
Interventions Rosiglitazone
Updated 6 times since 2017 Last updated: Oct 16, 2012 Started: Jul 31, 2005 Primary completion: May 31, 2006 Completion: May 31, 2006
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

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Listed as NCT00115661, this PHASE2 trial focuses on Endometriosis and remains terminated or withdrawn.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

~Jan 2017 – ~Feb 2017 · 31 days · monthly snapshotTerminated~Feb 2017 – ~Jun 2018 · 16 months · monthly snapshotTerminated~Jun 2018 – ~Jan 2021 · 31 months · monthly snapshotTerminated~Jan 2021 – ~Jul 2024 · 42 months · monthly snapshotTerminated~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotTerminated~Sep 2024 – present · 19 months · monthly snapshotTerminated

Change History

6 versions recorded
  1. Sep 2024 — Present [monthly]

    Terminated PHASE2

  2. Jul 2024 — Sep 2024 [monthly]

    Terminated PHASE2

  3. Jan 2021 — Jul 2024 [monthly]

    Terminated PHASE2

  4. Jun 2018 — Jan 2021 [monthly]

    Terminated PHASE2

  5. Feb 2017 — Jun 2018 [monthly]

    Terminated PHASE2

Show 1 earlier version
  1. 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

Sponsor contact:
  • Berlex Foundation
  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Data source: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations