Atypical Endometrial HyperplasiaPhase 2NCT00788671

Levonorgestrel-Releasing Intrauterine System in Treating Patients With Complex Atypical Hyperplasia or Grade I Endometrial Cancer

A Phase 2 study testing Laboratory Biomarker Analysis, Levonorgestrel-Releasing Intrauterine System and Quality-of-Life Assessment in people with Atypical Endometrial Hyperplasia and Stage I Uterine Corpus Cancer AJCC v7, run by M.D. Anderson Cancer Center at 7 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older, women only
Conditions the study is for: Atypical Endometrial Hyperplasia, Stage I Uterine Corpus Cancer AJCC v7, Stage IA Uterine Corpus Cancer AJCC v7
What is being tested?: Laboratory Biomarker Analysis, Levonorgestrel-Releasing Intrauterine System and Quality-of-Life Assessment
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 69 participants
Where: 7 sitesUnited States
Study dates: 3 Nov 2008to 30 Nov 2027
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.
Evidence of extrauterine spread of disease on imaging or during surgical evaluation.
Congenital or acquired uterine anomaly which distorts the uterine cavity.
Acute pelvic inflammatory disease.
Acute liver disease or previously diagnosed liver tumor (benign or malignant).

Show all 11Show fewer

Conditions associated with increased susceptibility to infections with microorganisms. Such conditions include, but are not limited to, AIDS, leukemia and IV drug abuse.
Genital actinomycosis.
Current carcinoma of the breast.
Current pregnancy.
Breastfeeding mothers.

Trial locations and contacts

7 sites in 1 country.

City, postcode or hospital

7 sites in 1 country

United States7 sites

Lyndon Baines Johnson General Hospital
Houston, Texas, 77026-1967
M D Anderson Cancer Center
Houston, Texas, 77030
The Woman's Hospital of Texas
Houston, Texas, 77054
MD Anderson in Katy
Houston, Texas, 77094
MD Anderson League City
Nassau Bay, Texas, 77058
MD Anderson in Sugar Land
Sugar Land, Texas, 77478
MD Anderson in The Woodlands
The Woodlands, Texas, 77384

Other trials in United States

About this study

Official title: A Phase II Study of the Levonorgestrel Intrauterine Device (Mirena) to Treat Complex Atypical Hyperplasia and Grade 1 Endometrioid Endometrial Carcinoma

Read the detailed description

PRIMARY OBJECTIVES:

To determine the efficacy of the levonorgestrel intrauterine device (IUD) (levonorgestrel-releasing intrauterine system) to treat complex atypical hyperplasia (CAH) and grade 1 endometrioid endometrial carcinoma (G1 EEC).

II. To determine if response to therapy can be predicted based on the molecular profile of the tumor or by change in gene expression after therapy.

SECONDARY OBJECTIVES:

To assess quality of life outcomes in patients treated with levonorgestrel IUD.

II. To document the toxicity profile of the levonorgestrel IUD in the treatment of complex atypical hyperplasia and grade 1 endometrioid endometrial cancer.

III. To evaluate the molecular profile of the hysterectomy specimen of patients treated with the levonorgestrel IUD. Compare molecular profile in pretreatment tissue to hysterectomy tissue between responders and non-responders to levonorgestrel IUD therapy.

IV. To evaluate long-term survival, disease status, and fertility outcomes in patients with levonorgestrel IUD.

OUTLINE:

Patients undergo placement of a levonorgestrel-releasing intrauterine system.

After completion of study treatment, patients are followed up every 3 months for 1 year, and then periodically for up to 5 years.

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
Being tested: Laboratory Biomarker Analysis, Levonorgestrel-Releasing Intrauterine System, Quality-of-Life Assessment
Medical subject headings: Endometrial Hyperplasia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Laboratory Biomarker AnalysisOther
Correlative studies
Levonorgestrel-Releasing Intrauterine SystemDevice
Also called Mirena
Undergo placement of a levonorgestrel-releasing intrauterine system
Quality-of-Life AssessmentOther
Also called Quality of Life Assessment
Ancillary studies

Study groups in NCT00788671
Study group	Role	What they receive
Treatment (levonorgestrel-releasing intrauterine system)	Experimental	Patients undergo placement of a levonorgestrel-releasing intrauterine system. Receives: Other: Laboratory Biomarker Analysis; Device: Levonorgestrel-Releasing Intrauterine System; Other: Quality-of-Life Assessment

What is being measured

The primary outcome is the main question the study is designed to answer.

Response Rate at 12 Month
Will be defined as complete response or partial response based on the endometrial biopsy.
Measured: At 1 year
Efficacy of the Levonorgestrel Intrauterine Device (IUD)
To determine the efficacy of the Levonorgestrel Intrauterine Device (IUD) to treat complex atypical hyperplasia (CAH) and grade 1 endometrioid endometrial carcinoma (G1 EEC), defined as complete regression disease. The primary efficacy endpoint was pathologic response rate (RR) at 12 months defined as complete response (CR) or partial response (PR). CR was defined as no evidence of cancer or hyperplasia with atypia in patients with (CAH) or EEC. PR was defined as CAH in patients with EEC. Progressive disease (PD) was defined as grade 2 endometrioid endometrial cancer or above in patients with EEC or the presence of any cancer in patients with CAH.
Measured: At 1 year

Secondary outcomes (1)

Quality of Life Score Using the Short Form-36 (SF-36) Survey
SF-36 is a standardized survey evaluating 8 aspects of functional health and well being (physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health); 2 summary scores (physical and mental component); and self evaluated change in health status (summary of health status). The score for subscale scores and 2 summary score is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). Summary of health status is a 5-point Likert scale ranging from "0=much worse now" to "4=much better now". Higher subscale and summary score reflect better health status.
Measured: At baseline, 3 month, 6 month, 9 month and 12 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

3 Nov 200830 Nov 2027

First posted11 Nov 2008 (estimated)
Study start3 Nov 2008
Primary completion10 Jun 2016
Study completion30 Nov 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Atypical Endometrial HyperplasiaStudies of the same condition, open and under way.
More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 69 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00788671
Sponsor's protocol ID: 2008-0094
Other IDs: NCI-2012-02118, 2008-0094, P50CA098258
Status last verified: Oct 2026
First submitted: 10 Nov 2008
Last updated: 27 Oct 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes

Publications

Westin SN, Fellman B, Sun CC, Broaddus RR, Woodall ML, Pal N, Urbauer DL, Ramondetta LM, Schmeler KM, Soliman PT, Fleming ND, Burzawa JK, Nick AM, Milbourne AM, Yuan Y, Lu KH, Bodurka DC, Coleman RL, Yates MS. Prospective phase II trial of levonorgestrel intrauterine device: nonsurgical approach for complex atypical hyperplasia and early-stage endometrial cancer. Am J Obstet Gynecol. 2021 Feb;224(2):191.e1-191.e15. doi: 10.1016/j.ajog.2020.08.032. Epub 2020 Aug 15.
PubMed 32805208

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Liquid Biopsy-Based Early Screening for Endometrial Cancer in Regional Chinese Populations
Endometrial Cancer, Atypical Endometrial Hyperplasia
Not yet recruitingPhase 2
Canagliflozin Plus Progestin for Atypical Endometrial Hyperplasia and Early-Stage Endometrial Cancer
Endometrioid Endometrial Cancer, Atypical Endometrial Hyperplasia
RecruitingPhase 2
A Study to Estimate Early Clinical Efficacy Signals of GLP-1 Agonist Administration in Conjunction With Levonorgestrel Intrauterine Device in Obese Patients With Endometrioid Intraepithelial Neoplasia
Endometrioid Endometrial Adenocarcinoma
Active, not recruitingObservational study
Endometrial Cancer Vaginal Fluid Specimen Collection Study
Abnormal Uterine Bleeding (AUB), Endometrial Cancer

All Atypical Endometrial Hyperplasia trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase II Study of the Levonorgestrel Intrauterine Device (Mirena) to Treat Complex Atypical Hyperplasia and Grade 1 Endometrioid Endometrial Carcinoma
ClinicalTrials.gov ID: NCT00788671
Acronym / sponsor ID: 2008-0094
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
Phase: Phase 2
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 69 participants (actual)
Lead sponsor: M.D. Anderson Cancer CenterUniversity, hospital or other
Collaborators: National Cancer Institute (NCI)
Study start: 3 Nov 2008 (actual)
Primary completion: 10 Jun 2016 (actual)
Study completion: 30 Nov 2027 (estimated)
First posted: 11 Nov 2008 (estimated)
Results: Posted 28 Apr 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

PRIMARY OBJECTIVES:

To determine the efficacy of the levonorgestrel intrauterine device (IUD) (levonorgestrel-releasing intrauterine system) to treat complex atypical hyperplasia (CAH) and grade 1 endometrioid endometrial carcinoma (G1 EEC).

II. To determine if response to therapy can be predicted based on the molecular profile of the tumor or by change in gene expression after therapy.

SECONDARY OBJECTIVES:

To assess quality of life outcomes in patients treated with levonorgestrel IUD.

II. To document the toxicity profile of the levonorgestrel IUD in the treatment of complex atypical hyperplasia and grade 1 endometrioid endometrial cancer.

IV. To evaluate long-term survival, disease status, and fertility outcomes in patients with levonorgestrel IUD.

OUTLINE:

Patients undergo placement of a levonorgestrel-releasing intrauterine system.

After completion of study treatment, patients are followed up every 3 months for 1 year, and then periodically for up to 5 years.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Treatment (levonorgestrel-releasing intrauterine system)	Experimental	Other: Laboratory Biomarker Analysis, Device: Levonorgestrel-Releasing Intrauterine System, Other: Quality-of-Life AssessmentPatients undergo placement of a levonorgestrel-releasing intrauterine system.

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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.

Key exclusion criteria (11 listed)

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.
Evidence of extrauterine spread of disease on imaging or during surgical evaluation.
Congenital or acquired uterine anomaly which distorts the uterine cavity.
Acute pelvic inflammatory disease.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Laboratory Biomarker AnalysisCorrelative studies	Other	Treatment (levonorgestrel-releasing intrauterine system)
Levonorgestrel-Releasing Intrauterine SystemAlso: MirenaUndergo placement of a levonorgestrel-releasing intrauterine system	Device	Treatment (levonorgestrel-releasing intrauterine system)
Quality-of-Life AssessmentAlso: Quality of Life AssessmentAncillary studies	Other	Treatment (levonorgestrel-releasing intrauterine system)

Primary outcome

Response Rate at 12 Month
Time frame: At 1 year
Will be defined as complete response or partial response based on the endometrial biopsy.
Efficacy of the Levonorgestrel Intrauterine Device (IUD)
Time frame: At 1 year
To determine the efficacy of the Levonorgestrel Intrauterine Device (IUD) to treat complex atypical hyperplasia (CAH) and grade 1 endometrioid endometrial carcinoma (G1 EEC), defined as complete regression disease. The primary efficacy endpoint was pathologic response rate (RR) at 12 months defined as complete response (CR) or partial response (PR). CR was defined as no evidence of cancer or hyperplasia with atypia in patients with (CAH) or EEC. PR was defined as CAH in patients with EEC. Progressive disease (PD) was defined as grade 2 endometrioid endometrial cancer or above in patients with EEC or the presence of any cancer in patients with CAH.

1 secondary outcome

Quality of Life Score Using the Short Form-36 (SF-36) Survey
Time frame: At baseline, 3 month, 6 month, 9 month and 12 month

Results and safety

Results posted to the registry on 28 Apr 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Treatment	57	47

Primary outcome: Response Rate at 12 Month

Time frame: At 1 year. Number (90% Confidence Interval). Unit: percentage of participants

Measure	Treatment n = 47
Value	83 (72.7 to 90.3)

Primary outcome: Efficacy of the Levonorgestrel Intrauterine Device (IUD)

Time frame: At 1 year. Count of participants. Unit: Participants

Measure	Treatment n = 47
Complete Responders	37
Partial Responders	2
Stable Disease	3
Progressive Disease	5

1 secondary outcome is reported in the full results.

Adverse events

Time frame: From baseline through 30 days following the IUD removal, up to 12 months. Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Treatment	0 of 57 (0%)	26 of 57 (45.6%)	2 of 57

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 32805208Westin SN, Fellman B, Sun CC, Broaddus RR, Woodall ML, Pal N, Urbauer DL, Ramondetta LM, Schmeler KM, Soliman PT, Fleming ND, Burzawa JK, Nick AM, Milbourne AM, Yuan Y, Lu KH, Bodurka DC, Coleman RL, Yates MS. Prospective phase II trial of levonorgestrel intrauterine device: nonsurgical approach for complex atypical hyperplasia and early-stage endometrial cancer. Am J Obstet Gynecol. 2021 Feb;224(2):191.e1-191.e15. doi: 10.1016/j.ajog.2020.08.032. Epub 2020 Aug 15.
M D Anderson Cancer CenterLink provided by the sponsor.

Related trials for Atypical Endometrial Hyperplasia

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Leveraging Methylated DNA Markers (MDMs) in the Detection of Endometrial Cancer, Ovarian Cancer, and Cervical Cancer
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RecruitingObservational study
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Active, not recruitingObservational study
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Shannon N Westin principal investigator

M.D. Anderson Cancer Center

7 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Apr 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Response Rate at 12 Month (time frame: At 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00788671, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026.