Medical Treatment of Endometriosis-Associated Pelvic Pain
Condition: Endometriosis; Pelvic Pain
MeSH terms: Endometriosis; Pelvic Pain
Study type: Interventional
Phase: Phase 3

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.
    

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).
    

Intervention name(s): Oral Contraceptive; Depot-Leuprolide/Norethindrone
Intervention type(s): Drug; Drug
Intervention MeSH terms: Leuprolide; Norethindrone; Norethindrone Acetate; Contraceptive Agents; Contraceptives, Oral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: endometriosis; pelvic pain; treatment