Medical Treatment of Endometriosis-Associated Pelvic Pain

NCT00229996 | Completed Phase 3

• 1 other identifier: R01HD044870
• Study Type: interventional
• Target: 194
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Endometriosis; Pelvic Pain

Keywords

endometriosis; pelvic pain; treatment

Outcome Measures

Primary Outcomes (2)

• pain

• quality of life

Interventions

Oral Contraceptive DRUG

Depot-Leuprolide/Norethindrone DRUG

Eligibility Criteria

• Age: 18 Years - 52 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age greater than 18 and pre-menopausal.
• Pelvic pain of at least 3 months duration.
• Diagnosis of endometriosis by laparoscopy or laparotomy within three years of entry. The diagnosis of endometriosis will require either histology consistent with endometriosis or operative records indicating visual evidence of lesions consistent with endometriosis.
• Moderate to severe pelvic pain preoperatively attributable to endometriosis (average Numerical Rating Scale of 5 or more for three or more months).
• Willingness to comply with visit schedule and protocol.

You may not qualify if:

• Use of oral contraceptives within one month of the surgery.
• Dose of Lupron within three months if given monthly or within five months if given 3-month injection.
• Any disorder that represents a contraindication to the use of oral contraceptives (e.g. insulin-dependent diabetes mellitus, history of thrombophlebitis, hypertension, history of cardiovascular disease, smoker at 35 or more years of age) or GnRH analogs (e.g., history of osteopenia).
• History of hysterectomy and bilateral salpingoophorectomy.
• Positive pregnancy test at first postoperative (i.e, intake visit).
• Significant mental or chronic systemic illness that might confound pain assessment or the inability to complete the study.

Sponsors & Collaborators

• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): lead

Study Sites (1)

Brigham and Womens Hospital

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Endometriosis; Pelvic Pain

Interventions

Contraceptives, Oral; Norethindrone

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Contraceptive Agents, Female; Contraceptive Agents; Reproductive Control Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Therapeutic Uses; Norpregnenes; Norpregnanes; Norsteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• David S Guzick, M.D., Ph.D

  University of Rochester

  PRINCIPAL INVESTIGATOR

• Mark Hornstein, MD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

• Fred M Howard, MD

  University of Rochester

  PRINCIPAL INVESTIGATOR

• Sara Sukalich, MD

  University of Rochester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NIH

Study Record Dates

• First Submitted: September 28, 2005
• First Posted: September 30, 2005
• Study Start: July 1, 2004
• Last Updated: January 24, 2014

Record last verified: 2014-01

Locations

US (1)