Clinical trial · Interventional
Megestrol Acetate or Levonorgestrel-Releasing Intrauterine System in Treating Patients With Atypical Endometrial Hyperplasia or Endometrial Cancer
A Phase II Head-to-Head Comparison of Fertility-Sparing Approaches to Treat Complex Atypical Hyperplasia of the Edometrium: Megestrol Versus Levonorgestrel-Releasing Intrauterine System (LNG-IUS)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Lack of funding
Summary
Brief summary (as posted)
This randomized phase II trial studies how well megestrol acetate or levonorgestrel-releasing intrauterine system works in treating patients with atypical endometrial hyperplasia or endometrial cancer. Progesterone can cause the growth of endometrial cancer cells. Hormone therapy using megestrol acetate or levonorgestrel-releasing intrauterine system may fight endometrial cancer by lowering the amount of progesterone the body makes. It is not yet known whether megestrol acetate is more effective than levonorgestrel-releasing intrauterine system in treating atypical endometrial hyperplasia or endometrial cancer.
Conditions
Conditions (11)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Atypical Endometrial Hyperplasia | Endometrial Atypical Hyperplasia/Endometrioid Intraepithelial Neoplasia | ALIAS | 0.90 |
| Endometrial Adenocarcinoma | Endometrial Adenocarcinoma | CURATED_BROADER | 0.80 |
| Recurrent Endometrial Carcinoma | Endometrial Carcinoma | CURATED_BROADER | 0.78 |
| Stage IA Endometrial Carcinoma | Endometrial Carcinoma | CURATED_BROADER | 0.78 |
| Stage IB Endometrial Carcinoma | Endometrial Carcinoma | CURATED_BROADER | 0.78 |
| Stage II Endometrial Carcinoma | Endometrial Carcinoma | CURATED_BROADER | 0.78 |
| Stage IIIA Endometrial Carcinoma | Endometrial Carcinoma |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| levonorgestrel-releasing intrauterine system | Device | — | UNRESOLVED |
| megestrol acetate | Drug | Megestrol | ALIAS |
| questionnaire administration | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm A (megestrol acetate)
- description
- Patients receive megestrol acetate PO BID for up to 18 months in the absence of disease progression or unacceptable toxicity.
- interventionNames
- Drug: megestrol acetate
- Other: laboratory biomarker analysis
- Other: questionnaire administration
- type
- EXPERIMENTAL
- label
- Arm B (levonorgestrel-releasing IUS)
- description
- Patients receive levonorgestrel-releasing IUS with continuous release for up to 18 months in the absence of disease progression or unacceptable toxicity.
- interventionNames
- Device: levonorgestrel-releasing intrauterine system
- Other: laboratory biomarker analysis
- Other: questionnaire administration
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 44 Years
Show eligibility criteria text
Inclusion Criteria: * A histologic diagnosis of complex atypical hyperplasia or grade 1 endometrioid adenocarcinoma of the endometrium diagnoses within 3 months of study enrollment who strongly desire to maintain fertility * A diagnosis of endometrioid adenocarcinoma will undergo a magnetic resonance imaging (MRI) scan of the pelvis to rule out deep (\> 50%) myometrial invasion and extrauterine metastases * A negative urine or serum pregnancy test at the time of enrollment * Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 90 days following completion of therapy; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately; a female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria: * Has not undergone a hysterectomy or bilateral oophorectomy; or * Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months) * Willing and able to consent for treatment with office endometrial biopsies every 3 months * Ability to understand and the willingness to sign a written informed consent Exclusion Criteria: * A diagnosis of grade 1 endometrioid adenocarcinoma of the endometrium who does not wish to maintain fertility * MRI evidence of deep myometrial and/or extrauterine spread * Congenital or other structural uterine or tubal abnormality * An acute pelvic inflammatory disease or medical conditions, such as, but not limited to acquired immunodeficiency syndrome (AIDS) and chronic immunosuppression, that may be associated with an increased susceptibility to infections * Current diagnosis of breast cancer or any other cancer * Currently pregnant or breastfeeding * Thromboembolic disease, deep vein thrombosis, hypercoagulable state
References
Publications (0)
Data not yet available