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New treatment option for Endometrial Hyperplasia
Official title Uterine Preservation Via Lifestyle Transformation
ClinicalTrials.gov ID: NCT05903131
What this study is testing
What is Progestin?
Progestin is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for endometrial hyperplasia.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- 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...
- 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...
- Premenopausal woman with a uterus.
- ECOG performance status of 0-2.
You likely can't join if
- 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...
- 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.
See the full eligibility criteria
- 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.
- 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- St Louis, Missouri, United States
- Albuquerque, New Mexico, United States
- Oklahoma City, Oklahoma, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include St Louis, Missouri, United States; Albuquerque, New Mexico, United States; Oklahoma City, Oklahoma, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.