Clinical trialNCT00229996CompletedPhase 3Interventional

Medical Treatment of Endometriosis-Associated Pelvic Pain

SponsorEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)Enrollment194EndometriosisPelvic Pain

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

The Specific Aim of this project is to compare the efficacy and cost-effectiveness of continuous oral contraceptives versus leuprolide/norethindrone in the treatment of endometriosis-associated chronic pelvic pain. This comparison will be based on a randomized, double-blind, trial of women with chronic pelvic pain who have been diagnosed with endometriosis at the time of surgery within the last 3 years. We hypothesize that, over a 12-month period of postoperative treatment, the efficacy of oral contraceptives is no worse than leuprolide/norethindrone, and that treatment with oral contraceptives is more cost-effective.

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Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

David S Guzick, M.D., Ph.D
University of Rochester
Principal Investigator
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Fred M Howard, MD
University of Rochester
Principal Investigator
clinicaltrials.gov ↗
Mark Hornstein, MD
Brigham and Women's Hospital
Principal Investigator
clinicaltrials.gov ↗
Sara Sukalich, MD
University of Rochester
Principal Investigator
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A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

1 registered facility, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States

Brigham and Womens Hospital
Boston, Massachusetts, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Depot-Leuprolide/NorethindroneOral Contraceptive

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 31 Jul 2004
Primary completion: —
Completion: —
Last update posted: 24 Jan 2014
Registered enrollment: 194
Registry id: NCT00229996

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.