NCT00788671Active, not recruitingPhase 2
Levonorgestrel-Releasing Intrauterine System in Treating Patients With Complex Atypical Hyperplasia or Grade I Endometrial Cancer
A Phase II Study of the Levonorgestrel Intrauterine Device (Mirena) to Treat Complex Atypical Hyperplasia and Grade 1 Endometrioid Endometrial Carcinoma
Source: ClinicalTrials.gov · Last updated 27 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 69 (actual)
- First submitted
- 10 Nov 2008
- Start date
- 3 Nov 2008
- Primary completion date
- 10 Jun 2016
- Lead sponsor
- M.D. Anderson Cancer Center
- Diseases
- Endometrial cancer
- NCT number
- NCT00788671
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 69
- From 3 Nov 2008 to the primary completion date, 10 Jun 2016
- 7 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Acute liver disease or previously diagnosed liver tumor (benign or malignant).
Other illness
- Evidence of extrauterine spread of disease on imaging or during surgical evaluation.
- Acute pelvic inflammatory disease.
- Conditions associated with increased susceptibility to infections with microorganisms. Such conditions include, but are not limited to, AIDS, leukemia and IV drug abuse.
Other
- Diagnosis of grade 1 endometrioid endometrial carcinoma without the presence of one of the 3 criteria mentioned in inclusion criteria 1.
- Diagnosis of grade 2 endometrioid endometrial carcinoma or higher on endometrial biopsy or on dilation and curettage specimen.
- Congenital or acquired uterine anomaly which distorts the uterine cavity.
- Genital actinomycosis.
- Current carcinoma of the breast.
- Current pregnancy.
- Breastfeeding mothers.
Who the study is looking for
- All patients with a diagnosis of complex atypical hyperplasia or endometrial biopsy within three months of study enrollment OR patients with a diagnosis of grade 1 endometrioid endometrial carcinoma on endometrial biopsy within three months of study enrollment in the presence of one or more of the following: 1)desire for future fertility 2)morbid obesity (body mass index \> 40) 3)multiple co-morbidities (ASA Class 3 or 4)
- No prior treatment for diagnoses in inclusion criteria 1.
- Women of any racial or ethnic group.
- Ability to comply with endometrial biopsies every 3 months.
- Willing and able to sign informed consent.
- Age greater than 18 years.
Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers
Sites (7)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The Woman's Hospital of Texas Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| M D Anderson Cancer Center Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| MD Anderson in Katy Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| Lyndon Baines Johnson General Hospital Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| MD Anderson League City Coordinator of this site? Confirm its status | Nassau Bay | United States | Unknown status |
| MD Anderson in Sugar Land Coordinator of this site? Confirm its status | Sugar Land | United States | Unknown status |
| MD Anderson in The Woodlands Coordinator of this site? Confirm its status | The Woodlands | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.