Clinical trial · Interventional
Megestrol in Treating Patients With Endometrial Neoplasia or Endometrial Hyperplasia
A Randomized Phase II Evaluation of Continuous Progestin Therapy vs. Sequential Progestin Therapy in the Treatment of Endometrial Intraepithelial Neoplasia (EIN) From a Referred Cohort of Atypical Endometrial Hyperplasia (AEH) or EIN Patients That Desire Uterine Preservation
NCT00503581CI-TRIAL-00048079terminatedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This randomized phase II trial is studying how well megestrol works in treating patients with endometrial neoplasia or endometrial hyperplasia. Estrogen can cause the growth of endometrial cancer cells. Hormone therapy using megestrol may fight endometrial cancer by blocking the use of estrogen by the abnormal cells.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| High Grade Squamous Intraepithelial Neoplasia | High Grade Squamous Intraepithelial Neoplasia | ONTOLOGY_EXACT | 0.98 |
| Stage 0 Uterine Corpus Cancer | Malignant Uterine Corpus Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Biopsy | Procedure | — | UNRESOLVED |
| Laboratory Biomarker Analysis | Other | — | UNRESOLVED |
| Megestrol Acetate | Drug | Megestrol | ALIAS |
| Pharmacological Study | Other | — | UNRESOLVED |
| Quality-of-Life Assessment | Other | — | UNRESOLVED |
| Therapeutic Conventional Surgery | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Regimen 1 (megestrol acetate, surgery)
- description
- Patients receive oral megestrol twice daily every day for 24 weeks. Approximately twelve weeks after treatment starts, clinical blood tests are obtained and research serum and plasma collected. Twenty-four weeks constitutes one course of treatment and a pill count is performed during the 12-week f/u visit and at the completion of the treatment course to determine compliance. After progestin therapy the patient has an induced-withdrawal bleed. Patients in this arm undergo a re-evaluation biopsy and hysterectomy a minimum of two weeks and a maximum of eight weeks after completing the megestrol treatment.
- interventionNames
- Procedure: Biopsy
- Other: Laboratory Biomarker Analysis
- Drug: Megestrol Acetate
- Other: Pharmacological Study
- Other: Quality-of-Life Assessment
- Procedure: Therapeutic Conventional Surgery
- type
- EXPERIMENTAL
- label
- Regimen 2 (megestrol acetate, surgery)
- description
- Patients receive oral megestrol twice daily for two weeks continuously followed by no treatment for two weeks. This course is repeated for a total of 24 weeks. Approximately twelve weeks after treatment starts, clinical blood tests are obtained and research serum and plasma collected. Twenty-four weeks constitutes one course of treatment and a pill count is performed during the 12-week f/u visit and at the completion of the treatment course to determine compliance. After progestin therapy the patient has an induced-withdrawal bleed. Patients in this arm undergo a re-evaluation biopsy and hysterectomy a minimum of two weeks and a maximum of eight weeks after the megestrol treatment.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients must have a diagnosis of atypical endometrial hyperplasia (AEH) or endometrial intraepithelial neoplasia (EIN) diagnosed by dilatation and curettage (D\&C), Novak curettage, Vabra aspirate, or Pipelle endometrial biopsy at the enrolling institution within 12 weeks of enrollment * Patients must desire uterine retention for duration of study (18 months or after 3rd biopsy) if they remain EIN negative (-); patients are allowed to attempt pregnancy after their initial post-treatment biopsy without it being a major protocol violation * Patients must have a GOG performance status of 0, 1, or 2 * White blood cell (WBC) \>= 3000 * Platelets \>= 100,000 * Granulocytes \>= 1,500 * Creatinine =\< 2 * Bilirubin =\< 1.5 x institutional upper limit normal * Serum glutamic oxaloacetic transaminase (SGOT) =\< 3 x institutional upper limit normal * Alkaline phosphatase =\< 3 x institutional upper limit normal * Patients of child-bearing potential must have a negative serum pregnancy test prior to starting study drug and prior to each biopsy if capable of becoming pregnant (and at the discretion of the referring physician) * Patients of childbearing potential must use appropriate non-hormonal contraception while on study medication * Patients who have met the pre-entry requirements * Patients must have signed an approved informed consent and authorization permitting release of personal health information Exclusion Criteria: * Patients with a GOG performance status of 3 or 4 * Patients with recognized endometrial carcinoma * Patients with current or prior history of breast cancer * Patients with invasive malignancies, with the exception of nonmelanoma skin cancer who had (or have) any evidence of the other cancer present within the past 5 years or whose previous cancer treatment contraindicates this protocol therapy * Patients who have received prior radiotherapy to any portion of the abdominal cavity or pelvis are excluded * Patients who have received prior chemotherapy for any abdominal or pelvic tumor are excluded * Patients who are pregnant or lactating * Patients with a history of thrombophlebitis, thromboembolic phenomena, or cerebrovascular disorders within the past 5 years * Patients under 18 years of age
References
Publications (0)
Data not yet available
No reference posted for this study.