Fact CheckerSign in

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
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

Full criteria on ClinicalTrials.gov

Sites (7)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
The Woman's Hospital of Texas
Coordinator of this site? Confirm its status
HoustonUnited StatesUnknown status
M D Anderson Cancer Center
Coordinator of this site? Confirm its status
HoustonUnited StatesUnknown status
MD Anderson in Katy
Coordinator of this site? Confirm its status
HoustonUnited StatesUnknown status
Lyndon Baines Johnson General Hospital
Coordinator of this site? Confirm its status
HoustonUnited StatesUnknown status
MD Anderson League City
Coordinator of this site? Confirm its status
Nassau BayUnited StatesUnknown status
MD Anderson in Sugar Land
Coordinator of this site? Confirm its status
Sugar LandUnited StatesUnknown status
MD Anderson in The Woodlands
Coordinator of this site? Confirm its status
The WoodlandsUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.