Trial · NCT04576104
Megestrol Acetate Compared With Megestrol Acetate and Metformin to Prevent Endometrial Cancer
NCT04576104, Phase 2, Active not recruiting, Northwestern University
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Megestrol Acetate Compared With Megestrol Acetate and Metformin to Prevent Endometrial Cancer. Trials, record NCT04576104. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04576104
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Megestrol Acetate Compared With Megestrol Acetate and Metformin to Prevent Endometrial Cancer
- NCT number
- NCT04576104
- Status
- Active not recruiting
- Phases
- Phase 2
- Enrollment
- 51 participants, actual
- Lead sponsor
- Northwestern University
- Conditions
- Endometrial Atypical Hyperplasia/Endometrioid Intraepithelial Neoplasia, Endometrial Carcinoma
- Interventions
- Biopsy Procedure, Extended Release Metformin Hydrochloride, Megestrol Acetate, Questionnaire Administration
- First posted
- 2020-10-06
- Last updated
- 2026-01-21
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Ki-67 positive cells | Up to 42 days post planned procedure | Will measure the change in endometrial cell proliferation, as measured by the percentage of Ki-67 positive cells, in subjects treated with megestrol acetate + metformin compared to those treated with megestrol acetate alone, in all evaluable participants, and following stratification by menopausal status, as well as use of low dose, low potency progestins (yes/no). |
| Secondary | Changes in protein expression | Baseline up to 42 days post planned procedure | Measured by immunohistochemistry of samples in subjects treated with megestrol acetate + metformin compared to those treated with megestrol acetate alone. Additional analyses will be stratified for premenopausal and postmenopausal status, as well as use of low dose, low potency progestins (yes/no) to assess whether there are biologic differences in these two groups of women. i. Estrogen receptor and progesterone receptor; ii. PTEN/PAX2 expression; iii. Markers of the PI3K-Akt-mTOR pathway (phosphor-acetyl-CoA carboxylase, p(Ser473)-Akt, phosphor-S6K, p4EBP1);iv. Markers of cell death (TUNEL, cleaved caspase-3);v. Markers of intratumoral insulin signaling (Phosphorylated insulin receptor and insulin- like growth factor-1 receptor (total and phosphorylated IGF1R); vi. Mismatch repair deficiency (baseline only). |
| Other | Ki-67 expression | Baseline | Will explore whether baseline Ki-67 expression and other clinical characteristics are associated with treatment response. Will measure differences in the changes of Ki-67 expression of samples in subjects treated with megestrol acetate + metformin compared to those treated with megestrol acetate alone based upon the following characteristics: Baseline Ki-67 expression, ribonucleic acid sequencing analysis, and clinical characteristics (body mass index, age, etc.). |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants2
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|---|---|---|---|---|---|
| P30CA060553 | The Robert H. Lurie Comprehensive Cancer Center | PLATANIAS, LEONIDAS C. | NORTHWESTERN UNIVERSITY | NATIONAL CANCER INSTITUTE | 1993 to 2025 | NIH RePORTER |
| UG1CA242643 | Northwestern Cancer Prevention Consortium | KHAN, SEEMA AHSAN | NORTHWESTERN UNIVERSITY | NATIONAL CANCER INSTITUTE | 2019 to 2025 | NIH RePORTER |
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04576104
GET https://conductscience.org/api/trials/v1/NCT04576104/registered