Medical Treatment of Endometriosis-Associated Pelvic Pain
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|ClinicalTrials.gov Identifier: NCT00229996|
Recruitment Status : Completed
First Posted : September 30, 2005
Last Update Posted : January 24, 2014
|Condition or disease||Intervention/treatment||Phase|
|Endometriosis Pelvic Pain||Drug: Oral Contraceptive Drug: Depot-Leuprolide/Norethindrone||Phase 3|
- 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).
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||194 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Oral Contraceptives Versus Depot-Leuprolide Taken After Surgery for Endometriosis-Associated Pelvic Pain|
|Study Start Date :||July 2004|
- quality of life
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00229996
|United States, Massachusetts|
|Brigham and Womens Hospital|
|Boston, Massachusetts, United States, 02215|
|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|