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NCT00001848 · ClinicalTrials.gov registry record · Phase 2
The Safety and Effectiveness of Surgery With or Without Raloxifene for the Treatment of Pelvic Pain Caused by Endometriosis
A Phase 2 study, sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
- Completed
- Registry status
- Phase 2
- Development phase
- 612
- Enrollment target
NCT00001848: Completed Phase 2 study, sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
NCT00001848 is a Phase 2 study that has completed, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD). The registered enrollment target is 612 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (360% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00001848, a Phase 2 study, has completed, sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 612 participants
- Enrollment target
Study Summary
Many women with lower abdominal pain have endometriosis. Endometriosis is a condition in which the lining of the uterus (endometrium) is found outside of the uterus. The diagnosis of endometriosis is usually made at surgery. The treatment of endometriosis includes medical and surgical approaches alone or in combination. The hormone estrogen stimulates the growth of the endometrium and may also stimulate the growth of endometriosis. Medical therapies that act to decrease the level of estrogen can reduce the amount of endometriosis and pain. When therapies are discontinued, symptoms often return. In addition, medical treatment for endometriosis is expensive and is often associated with weak bones (osteoporosis) and hot flashes as a result of low levels of estrogen. Surgical treatment is removal or destruction of the endometriosis tissue. Studies show the pain from endometriosis is relieved longer with tissue removal than with destruction. This study was developed to see if surgery followed by daily doses of Raloxifene (Evista) is effective in reducing pain, for a longer time than surgery in combination with a placebo (inactive "sugar pill") treatment. Raloxifene acts like estrogens in some tissues and not like estrogens in others. Postmenopausal women receiving Raloxifene for the prevention of osteoporosis had an increase in bone density and an improvement of their blood lipids (fat content in the blood). However, unlike estrogen, Raloxifene does not promote the growth of breast tissue or the uterus. If Raloxifene blocks estrogen action in the lining of the uterus (endometrium) of reproductive age women, as it does in post-menopausal women, it may also limit the growth of endometriosis and prevent the return of pain.
Interventions
- DRUG Raloxifene
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 612 participants |
| Start Date | 1998-11 |
| Est. Completion | 2006-01 |
| Phase | Phase 2 |
Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)305 total trials
What the finished NCT00001848 record still lists
NCT00001848 is an interventional study that assigns participants to a tested intervention. The registered 612 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (360% higher).
The record links to 0 conditions, and to 1 intervention - of which Raloxifene is the first listed.
NCT00001848 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00001848 about?
NCT00001848 is a clinical study titled "The Safety and Effectiveness of Surgery With or Without Raloxifene for the Treatment of Pelvic Pain Caused by Endometriosis". Many women with lower abdominal pain have endometriosis. Endometriosis is a condition in which the lining of the uterus (endometrium) is found outside of the uterus. The diagnosis of endometriosis is usually made at surgery. The treatment of endometriosis includes medical and surgical approaches alo...
What is the current status of trial NCT00001848?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 612 participants. The study started on 1998-11. Estimated completion is 2006-01.
What interventions are being tested in trial NCT00001848?
The interventions under investigation include: Raloxifene (DRUG).
Who is sponsoring clinical trial NCT00001848?
This trial is sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), which has 305 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00001848's enrollment target sits among peer trials
612 53rd of 2000 higher than 1,948 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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