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CompletedNCT00229996Updated Jan 24, 2014

Medical Treatment of Endometriosis-Associated Pelvic Pain

A Phase 3 interventional study of Oral Contraceptive and Depot-Leuprolide/Norethindrone in Endometriosis and Pelvic Pain, sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD). Completed at 1 site in United States. Open to female participants aged 18 Years to 52 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-01-24.

Sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
194
Allocation
Randomized
Ages
18 Years to 52 Years
Sex
Female
01

Study 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.

Read the detailed description
  • Background-Laparoscopic surgical treatment for endometriosis is typically associated with a decrease of pain on a short-term basis, but 50% of patients have pain 12 months after surgery. Often this leads to having repeat surgery to treat the endometriosis. Instead of having repeat surgery, some physicians use medications to prevent the pain and endometriosis from returning.
  • The purpose of this study is to compare continuous oral contraceptives to depot-leuprolide for control of endometriosis-associated pelvic pain after surgical treatment of endometriosis. We will also be looking at the potential cost savings of using oral contraceptives compared to depot-leuprolide, as depot-leuprolide is an expensive medication.
  • If the patient meets criteria, including confirmation of diagnosis of endometriosis, she will then undergo an intake visit consisting of obtaining informed consent and completion of several baseline questionnaires. This intake visit is estimated to last 1-2 hours. After informed consent has been obtained, the subject will be randomized to one of the two treatment groups:One tablet of oral contraceptives (birth control pills) everyday and an injection of saline (a sterile salt solution with no medication effect) every 12 weeks for 48 weeks or One tablet of norethindrone everyday and an injection of depot-leuprolide every 12 weeks for 48 weeks.
  • The patient will be seen one month after the first injection (Visit 1) and then at 12 (Visit 2), 24 (Visit 3), 36 (Visit 4) and 48 (Visit 5) weeks. Blood pressure and weight will be recorded and a urine pregnancy test will be obtained. The Study Coordinator will review with the patient any concerns she might have and record any adverse events. Assessments of pain and quality of life will be made at weeks 4, 12, 24, 36 and 48 after the intake visit. An injection (leuprolide acetate or saline plus inert powder) will be given by an unblinded nurse at the intake visit, and at weeks 12, 24, and 36. In addition, at the end of each medication visit, the patient will be given a three month's supply of oral medication (capsules containing norethindrone acetate or a generic oral contraceptive with 30ug ethinyl estradiol and 0.15mg levonorgestrel).
02

Conditions studied

  • Endometriosis
  • Pelvic Pain

Keywords

  • endometriosis
  • pelvic pain
  • treatment
03

In context

Endometriosis

901 studies on the registry are indexed under Endometriosis; 259 are open to participants now.

This study's planned enrollment of 194 is above the median of 64 across 525 interventional studies indexed under Endometriosis.

Browse Endometriosis studies →

Lead sponsor

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) is the lead sponsor of 416 studies on the registry; 25 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 10 (77%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 52 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double
Enrollment
194 participants (estimated)

Interventions

  • DrugOral Contraceptive
  • DrugDepot-Leuprolide/Norethindrone
06

What researchers measure

Primary outcomes

  1. pain

  2. quality of life

07

Study locations

1 site
  • Brigham and Womens Hospital
    Boston, Massachusetts 02215, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 24, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00229996
Lead sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted
Sep 30, 2005
Start date
Jul 2004
Last update
Jan 24, 2014

Study contacts

David S Guzick, M.D., Ph.D
principal investigator · University of Rochester
Mark Hornstein, MD
principal investigator · Brigham and Women's Hospital
Fred M Howard, MD
principal investigator · University of Rochester
Sara Sukalich, MD
principal investigator · University of Rochester
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2014. You cannot join it, but the record below documents what was studied.

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