drugset / Trial / NCT00229996
Medical Treatment of Endometriosis-Associated Pelvic Pain
Phase 3
Completed
194 enrolled
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
RandomizedParallel-groupDouble-blindTreatment
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.
Timeline
- Start
- 2004-07
- Primary completion
- —
- Completion
- —
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Leuprolide | Other / unclassified | — | Other |
| Subject | Levonorgestrel | Small molecule | 0.15 mg | Oral |
| Subject | Norethindrone | Unknown | — | Oral |
| Subject | ethinyl estradiol | Small molecule | 30 ug | Oral |