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Sponsored by: |
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
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Information provided by: | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
ClinicalTrials.gov Identifier: | NCT00229996 |
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.
Condition | Intervention | Phase |
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Endometriosis Pelvic Pain |
Drug: Oral Contraceptive Drug: Depot-Leuprolide/Norethindrone |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment |
Official Title: | Oral Contraceptives Versus Depot-Leuprolide Taken After Surgery for Endometriosis-Associated Pelvic Pain |
Estimated Enrollment: | 194 |
Study Start Date: | July 2004 |
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).
Ages Eligible for Study: | 18 Years to 52 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
United States, Massachusetts | |
Brigham and Womens Hospital | Recruiting |
Boston, Massachusetts, United States, 02215 | |
Contact: Betsy Broadman 617-732-4724 bbroadman@partners.org | |
United States, New York | |
University of Rochester | Recruiting |
Rochester, New York, United States, 14642 | |
Contact: Maureen Nealon 585-273-5734 maureen_nealon@urmc.rochester.edu |
Principal Investigator: | 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 |
Study ID Numbers: | R01HD044870 |
Study First Received: | September 28, 2005 |
Last Updated: | November 6, 2006 |
ClinicalTrials.gov Identifier: | NCT00229996 History of Changes |
Health Authority: | United States: Federal Government |
endometriosis pelvic pain treatment |
Genital Diseases, Female Signs and Symptoms Pelvic Pain Antineoplastic Agents, Hormonal Norethindrone Contraceptive Agents |
Leuprolide Contraceptives, Oral Contraceptive Agents, Female Endometriosis Pain Norethindrone acetate |
Antineoplastic Agents, Hormonal Antineoplastic Agents Contraceptive Agents Contraceptives, Oral Physiological Effects of Drugs Contraceptive Agents, Female Endometriosis Pain Reproductive Control Agents Pharmacologic Actions |
Genital Diseases, Female Signs and Symptoms Pelvic Pain Norethindrone Leuprolide Fertility Agents, Female Therapeutic Uses Fertility Agents Contraceptives, Oral, Synthetic |