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Endometrial HyperplasiaPhase 2NCT05903131

Uterine Preservation Via Lifestyle Transformation

A Phase 2 study testing Telemedicine behavioral weight intervention, Progestin and Levonorgestrel-releasing IUD. in people with Endometrial Hyperplasia and Grade 1 Endometrial Cancer, run by Washington University School of Medicine at 3 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Up to 60% of endometrial cancer cases are attributed to obesity, in part because obesity promotes development of atypical endometrial hyperplasia (AEH), and up to 40% of women with AEH go on to develop endometrial cancer. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
Telemedicine behavioral weight intervention, Progestin and Levonorgestrel-releasing IUD.
Could I receive a placebo?
No, everyone receives an active treatment
How many people
96 participants
Where
3 sitesUnited States
Study dates
24 Oct 2024to 31 Oct 2029
Phase
Phase 2
Are there results?
Not yet: the study is under way

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

  • Diagnosis of histologically confirmed complex atypical endometrial hyperplasia (AEH) or grade 1 endometrial cancer.
  • Patients with a previous diagnosis of AEH or grade 1 endometrial cancer who are already being followed with conservative management with oral or LNG-IUD progestin therapy are eligible.
  • For patients with a previous diagnosis of AEH or grade 1 endometrial cancer who have been placed on progestin prior to study entry, the duration of IUD or oral progestin use prior to trial entry should be documented.
  • Premenopausal woman with a uterus.
  • ECOG performance status of 0-2.
  • At least 18 years of age and no more than 45 years of age.
Show all 10Show fewer
  • Undergoing uterine-sparing management (e.g. due to interest in fertility preservation, interest in uterine preservation, provider recommendation, or other reason).
  • BMI ≥ 30 kg/m^2.
  • Prior or current receipt of progestin is allowed as above. Willingness to undergo placement of LNG-IUD at the time of study entry.
  • Ability to understand and willingness to sign an IRB approved written informed consent document.

Who cannot join

  • Current, active treatment for any malignant neoplasm with chemotherapy or radiation.
  • Pregnant and/or breastfeeding. Participants must have a negative urine or serum pregnancy test during screening window and within 7 days prior to LNG-IUD insertion. If LNG-IUD is in place, lack of pregnancy is assumed.
  • Active pelvic infection at the time of IUD placement or other contraindication to the use of an IUD in the opinion of the treating physician.

Trial locations and contacts

3 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Andrea R Hagemann, M.D., MSCI contact

314-362-1763

hagemanna@wustl.edu

United States3 sites, 3 recruiting

  • University of New Mexico

    Albuquerque, New Mexico, 87106

    Carolyn Muller, M.D., 505-272-2111

    Carolyn Muller, M.D.

    Recruiting

  • University of Oklahoma

    Oklahoma City, Oklahoma, 73104

    Kathleen Moore, M.D., MS, 405-271-8707

    Kathleen Moore, M.D., MS

    Recruiting

  • Washington University School of Medicine

    St Louis, Missouri, 63110

    Andrea R Hagemann, M.D., MSCI, 314-362-1763, hagemanna@wustl.edu

    Andrea R Hagemann, M.D., MSCI

    Recruiting

Other trials in United States

About this study

Official title: UPLifT-Endo: Uterine Preservation Via Lifestyle Transformation A Behavioral Intervention to Promote Primary Prevention and Uterine Preservation in Premenopausal Women With Obesity and Atypical Endometrial Hyperplasia or Grade 1 Endometrial Cancer

Up to 60% of endometrial cancer cases are attributed to obesity, in part because obesity promotes development of atypical endometrial hyperplasia (AEH), and up to 40% of women with AEH go on to develop endometrial cancer. The increasing prevalence of obesity in premenopausal women has resulted in increasing rates of AEH in this age group. Hysterectomy with removal of the fallopian tubes and ovaries is 100% effective in preventing endometrial cancer, but this approach results in infertility. Fertility-sparing treatments exist, such as treatment with oral or intrauterine progestin, but these treatments do not work uniformly and do not combat the underlying cause of endometrial cancer, which is obesity and metabolic syndrome. Additionally, up to 41% of women on progestin eventually experience relapse of AEH or endometrial cancer. Third, many patients have insulin resistance that may worsen with progestin therapy. Thus, to improve treatment of AEH and grade 1 endometrial cancer, prevent and reverse endometrial cancer, and allow women to preserve their fertility, the investigators must integrate an effective weight loss strategy to be given with progestin treatment. It is the hypothesis that premenopausal women with AEH desire uterine preservation will be more likely to have atypia-free uterine preservation at one year if they receive progestin in combination with a behavioral weight loss intervention versus progestin plus enhanced usual care.

Being tested
Telemedicine behavioral weight intervention, Progestin, Enhanced usual care, Levonorgestrel-releasing IUD.
Keywords
fertility-sparing, weight management, obesity, endometrial cancer, behavioral intervention, premenopausal endometrial hyperplasia, premenopausal endometrial cancer
Medical subject headings
Endometrial Hyperplasia, Obesity, Endometrial Neoplasms

What participants receive

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

  • Telemedicine behavioral weight interventionBehavioural

    Weekly telephone calls during the first month, biweekly during the next 5 months, and then monthly for the last 7 months (12 months total). Each telephone session will be 30 minutes long.

  • ProgestinDrug

    Released via the levonorgestrel-releasing IUD.

  • Enhanced usual careBehavioural

    1-3 page handouts

  • Levonorgestrel-releasing IUD.Drug

    Standard of care

Study groups in NCT05903131
Study groupRoleWhat they receive
Arm 1: Levonorgestrel-releasing IUD (LNG-IUD) + Behavioral Weight Loss InterventionExperimental* The levonorgestrel-releasing IUD is used in this study as per standard care. * The behavioral weight loss intervention consists of a telemedicine cognitive behavioral coaching program. At each session, patients will self-report weight, number of days they kept a food journal during the past week, average daily caloric intake for the week, number of days exercised for the week, total number of minutes of moderate physical activity, and average number of steps per day for the week.
Receives: Behavioral: Telemedicine behavioral weight intervention; Drug: Progestin; Drug: Levonorgestrel-releasing IUD.
Arm 2: Levonorgestrel-releasing IUD (LNG-IUD) + Enhanced Usual CareActive comparator* The levonorgestrel-releasing IUD is used in this study as per standard care. * Participants will be provided with 1- to 3-page handouts on topics including healthy eating, exercise, and behavioral eating strategies from materials provided on the American Cancer Society, Society of Gynecologic Oncology, and WebMD Nourish websites. These materials encourage weight loss through calorie counting, recording dietary intake, engaging in exercise programs, and using portion control strategies. * The participants randomized to this arm will cross over to the behavioral weight loss intervention arm at 12 months if they have not achieved resolution of AEH or grade 1 endometrial cancer.
Receives: Behavioral: Enhanced usual care; Drug: Levonorgestrel-releasing IUD.

What is being measured

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

  1. Number of participants with atypical endometrial hyperplasia (AEH)-free biopsy

    Measured: At 1 year

Secondary outcomes (6)

  1. Time to resolution of atypical endometrial hyperplasia (AEH)

    Defined as the period of time in months/days from the first biopsy to show AEH or grade 1 endometrial cancer to the first biopsy that shows no evidence of hyperplasia or malignancy

    Measured: Through completion of follow-up (estimated to be 2 years)

  2. Time to resolution of endometrial cancer

    Measured: Through completion of follow-up (estimated to be 2 years)

  3. Atypia-free survival

    -Defined as the time interval from the date of positive treatment response (as determined by biopsy) to the date of atypical endometrial hyperplasia (AEH) recurrence. AEH-free or the patients with lost to follow-up will be censored at the last follow-up.

    Measured: Through completion of follow-up (estimated to be 2 years)

  4. Endometrial cancer progression-free survival (EC-PFS)

    EC-PFS is defined as the time interval from the date of positive treatment response (as determined by biopsy) to the date of recurrence of EC. Endometrial cancer-free patients or the patients with lost to follow-up will be censored at the last follow-up.

    Measured: Through completion of follow-up (estimated to be 2 years)

  5. Change in weight

    Measured: Through completion of follow-up (estimated to be 2 years)

  6. Change in Cancer Worry Impact Events Scale (CWIES)

    The CWIES is a 15-item self-report measure evaluating stress reactions and traumatic experiences, specifically inquiring about cancer worry-specific distress. Range of values for each individual item will be a Likert Scale from 0-5. 0=not at all and 5=often. The higher the score, the more cancer-worry specific distress the participant has.

    Measured: At enrollment, 6 months, 12 months, end of intervention, and 24 months (estimated to be 2 years)

Timeline

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

  1. First posted15 Jun 2023
  2. Study start24 Oct 2024
  3. Primary completion31 Oct 2028 (estimated)
  4. Study completion31 Oct 2029 (estimated)

Resources

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
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
96 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05903131
Sponsor's protocol ID
202307204
Other IDs
P50CA265793
Status last verified
Jan 2026
First submitted
24 May 2023
Last updated
20 Jan 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Telemedicine behavioral weight intervention, Progestin and Levonorgestrel-releasing IUD. in people with Endometrial Hyperplasia and Grade 1 Endometrial Cancer, run by Washington University School of Medicine at 3 sites in United States.

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 10 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 20 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 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?

This study is still under way. Results are not available in the source record yet.

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

Contact Andrea R Hagemann, M.D., MSCI (314-362-1763, hagemanna@wustl.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of participants with atypical endometrial hyperplasia (AEH)-free biopsy (time frame: At 1 year). 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 NCT05903131.

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 20 Jan 2026.

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