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NCT00788671 · ClinicalTrials.gov registry record · Phase 2
Levonorgestrel-Releasing Intrauterine System in Treating Patients With Complex Atypical Hyperplasia or Grade I Endometrial Cancer
A Phase 2 study of Atypical Endometrial Hyperplasia and Stage I Uterine Corpus Cancer AJCC v7, sponsored by M.D. Anderson Cancer Center.
- Active
- Registry status
- Phase 2
- Development phase
- 69
- Enrollment target
- 7
- Study locations
NCT00788671: Active Phase 2 study of Atypical Endometrial Hyperplasia and Stage I Uterine Corpus Cancer AJCC v7, sponsored by M.D. Anderson Cancer Center.
NCT00788671 is a Phase 2 study of Atypical Endometrial Hyperplasia and Stage I Uterine Corpus Cancer AJCC v7 that is active but no longer recruiting, run by M.D. Anderson Cancer Center. The registered enrollment target is 69 participants, below the 1,033-participant average among 4 other Atypical Endometrial Hyperplasia trials with a reported enrollment target (93% lower). The trial reports 7 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00788671, a Phase 2 study of Atypical Endometrial Hyperplasia and Stage I Uterine Corpus Cancer AJCC v7, is active but no longer recruiting, sponsored by M.D. Anderson Cancer Center.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 69 participants
- Enrollment target
- 7
- Study locations
Study Summary
This phase II trial studies how well levonorgestrel-releasing intrauterine system works in treating patients with complex atypical hyperplasia or grade I endometrial cancer. High levels of estrogen can cause the growth of endometrial cancer cells. Progesterone can help balance the amount of estrogen present. Hormone therapy using levonorgestrel, a type of progesterone, may fight endometrial cancer by helping regulate hormone levels.
Primary Outcome
Will be defined as complete response or partial response based on the endometrial biopsy.
Conditions Studied
Interventions
- OTHER Quality-of-Life Assessment
- OTHER Laboratory Biomarker Analysis
- DEVICE Levonorgestrel-Releasing Intrauterine System
Study Locations (7)
Texas
- Lyndon Baines Johnson General Hospital - Houston
- M D Anderson Cancer Center - Houston
- The Woman's Hospital of Texas - Houston
- MD Anderson in Katy - Houston
- MD Anderson League City - Nassau Bay
- MD Anderson in Sugar Land - Sugar Land
- MD Anderson in The Woodlands - The Woodlands
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 69 participants |
| Start Date | 2008-11-03 |
| Est. Completion | 2027-11-30 |
| Phase | Phase 2 |
What the registry record for NCT00788671 still lists
NCT00788671 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 69 participants, a relatively small participant target, below the 1,033-participant average among 4 other Atypical Endometrial Hyperplasia trials with a reported enrollment target (93% lower).
The record links to 5 conditions, with Atypical Endometrial Hyperplasia appearing as the primary indexed condition, and to 3 interventions - of which Quality-of-Life Assessment is the first listed.
NCT00788671 lists 7 locations in 1 state (Texas).
Frequently Asked Questions
What is clinical trial NCT00788671 about?
NCT00788671 is a clinical study titled "Levonorgestrel-Releasing Intrauterine System in Treating Patients With Complex Atypical Hyperplasia or Grade I Endometrial Cancer". This phase II trial studies how well levonorgestrel-releasing intrauterine system works in treating patients with complex atypical hyperplasia or grade I endometrial cancer. High levels of estrogen can cause the growth of endometrial cancer cells. Progesterone can help balance the amount of estrogen...
What is the current status of trial NCT00788671?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 69 participants. The study started on 2008-11-03. Estimated completion is 2027-11-30.
What conditions does trial NCT00788671 study?
This clinical trial studies the following conditions: Atypical Endometrial Hyperplasia, Stage I Uterine Corpus Cancer AJCC v7, Stage IA Uterine Corpus Cancer AJCC v7, Stage IB Uterine Corpus Cancer AJCC v7, Stage II Uterine Corpus Cancer AJCC v7.
What interventions are being tested in trial NCT00788671?
The interventions under investigation include: Quality-of-Life Assessment (OTHER), Laboratory Biomarker Analysis (OTHER), Levonorgestrel-Releasing Intrauterine System (DEVICE).
Who is sponsoring clinical trial NCT00788671?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00788671 being conducted?
This trial has 7 study locations across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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