Trial · NCT00064025
Medroxyprogesterone in Treating Patients With Endometrioid Adenocarcinoma of the Uterine Corpus
NCT00064025, Phase 2, Completed, Gynecologic Oncology Group; results first posted 2014-08-15
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Medroxyprogesterone in Treating Patients With Endometrioid Adenocarcinoma of the Uterine Corpus. Trials, record NCT00064025. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00064025
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Medroxyprogesterone in Treating Patients With Endometrioid Adenocarcinoma of the Uterine Corpus
- NCT number
- NCT00064025
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 75 participants, actual
- Lead sponsor
- Gynecologic Oncology Group
- Conditions
Endometrial Adenocarcinoma, Endometrial Adenosquamous Carcinoma, Endometrial Endometrioid Adenocarcinoma, Variant With Squamous Differentiation, Recurrent Uterine Corpus Carcinoma, Stage I Uterine Corpus Cancer, Stage II Uterine Corpus Cancer, Stage III Uterine Corpus Cancer, Stage IV Uterine Corpus Cancer
- Interventions
- Laboratory Biomarker Analysis, Medroxyprogesterone, Therapeutic Conventional Surgery
- First posted
- 2003-07-09
- Last updated
- 2016-04-11
- Results first posted
- 2014-08-15
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Histologic Response in Endometrial Adenocarcinomas of the Uterine Corpus That Are Progesterone Receptor Positive Compared With Those That Are Progesterone Receptor Negative | During the hysterectomy, which is 21-24 days after administration of depo-provera | To determine the presence of a histologic response, the slide from the initial sample was compared to the slide from the matching hysterectomy specimen. A complete histologic response was defined as the absence of identifiable adenocarcinoma in the hysterectomy specimen section. A partial histologic response was subjectively defined in advance of the study based on criteria slightly modified from Wheeler et al. (Am J Surg Pathol 2007;31:988-98) as the presence of a complex proliferation of glands that retain the architectural characteristics of adenocarcinoma, but with features of secretion, decreased nuclear stratification, or the presence of eosinophilic, squamous or mucinous metaplasia, when this was absent in the initial sample. A complete or partial histologic response was considered a histologic response in the analysis of data. PR Positivity is based on aggregate score \>0.2 (vs. \<=0.2). Aggregate score based on product of staining intensity and area. |
| Secondary | Change From Pre- to Post-treatment in Estrogren Receptor (ER) Expression | During the hysterectomy, which is 21-24 days after administration of depo-provera | Expression is based on an aggregate score based on immunohistochemistry. Staining intensity was scored 1, 2, or 3; and staining area was scored as a percentage (0-100%). The aggregate score is the product of staining intensity and area and ranges from 0 to 3. |
| Secondary | Change From Pre- to Post-treatment in Progestrogren Receptor (PR) Expression | During the hysterectomy , which is 21-24 days after administration of depo-provera | Expression is based on an aggregate score based on immunohistochemistry. Staining intensity was scored 1, 2, or 3; and staining area was scored as a percentage (0-100%). The aggregate score is the product of staining intensity and area and ranges from 0 to 3. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Histologic Response in Endometrial Adenocarcinomas of the Uterine Corpus That Are Progesterone Receptor Positive Compared With Those That Are Progesterone Receptor Negative | During the hysterectomy, which is 21-24 days after administration of depo-provera | Eligible and Evaluable Patients (patients who had both an intake biopsy and hysterectomy and had histologic response data) | percentage of participants | NUMBER |
| SECONDARY | Change From Pre- to Post-treatment in Estrogren Receptor (ER) Expression | During the hysterectomy, which is 21-24 days after administration of depo-provera | Eligible and Evaluable Patients (patients who had both an intake biopsy and hysterectomy) | Aggregate Score from Immunohistochemistr | MEAN |
| SECONDARY | Change From Pre- to Post-treatment in Progestrogren Receptor (PR) Expression | During the hysterectomy , which is 21-24 days after administration of depo-provera | Eligible and Evaluable Patients (patients who had both an intake biopsy and hysterectomy) | Aggregate Score from Immunohistochemistr | MEAN |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Histologic Response in Endometrial Adenocarcinomas of the Uterine Corpus That Are Progesterone Receptor Positive Compared With Those That Are Progesterone Receptor Negative | PR Negative (<=0.2) | 62.5 | percentage of participants | ||
| Histologic Response in Endometrial Adenocarcinomas of the Uterine Corpus That Are Progesterone Receptor Positive Compared With Those That Are Progesterone Receptor Negative | PR Positive (>0.2) | 68.9 | percentage of participants | ||
| Change From Pre- to Post-treatment in Estrogren Receptor (ER) Expression | Depo-Provera | -0.77 | Standard Error 0.14 | Aggregate Score from Immunohistochemistr | |
| Change From Pre- to Post-treatment in Progestrogren Receptor (PR) Expression | Depo-Provera | -1.12 | Standard Error 0.15 | Aggregate Score from Immunohistochemistr |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Depo-Provera | 75 | |
| Overall Study | COMPLETED | Depo-Provera | 68 | |
| Overall Study | NOT COMPLETED | Depo-Provera | 7 |
Source ClinicalTrials.gov
Adverse events38
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Allergy/Immunology - Other | Immune system disorders | Depo-Provera | 1 | 68 | |
| other | Leukocytes | Blood and lymphatic system disorders | Depo-Provera | 2 | 68 | |
| other | Hemoglobin | Blood and lymphatic system disorders | Depo-Provera | 14 | 68 | |
| other | Fever | General disorders | Depo-Provera | 1 | 68 | |
| other | Rigors/Chills | General disorders | Depo-Provera | 1 | 68 | |
| other | Fatigue | General disorders | Depo-Provera | 6 | 68 | |
| other | Injection Site Reaction | Skin and subcutaneous tissue disorders | Depo-Provera | 2 | 68 | |
| other | Rash | Skin and subcutaneous tissue disorders | Depo-Provera | 2 | 68 | |
| other | Pruritus | Skin and subcutaneous tissue disorders | Depo-Provera | 1 | 68 | |
| other | Hot Flashes | Endocrine disorders | Depo-Provera | 1 | 68 |
1 to 10 of 38Source ClinicalTrials.gov
See all 38 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Depo-Provera | ||
| Total, other adverse events | Depo-Provera | 39 | 68 |
| Total, serious adverse events | Depo-Provera | 0 | 68 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants1
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 |
|---|---|---|---|---|---|
| U10CA027469 | Gynecologic Oncology Group | DISAIA, PHILIP J. | GYNECOLOGIC ONCOLOGY GROUP | NATIONAL CANCER INSTITUTE | 1985 to 2013 |
Source 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/NCT00064025
GET https://conductscience.org/api/trials/v1/NCT00064025/events?page=2