Trial · NCT00483327
Management of Atypical Endometrial Hyperplasia and Endometrial Carcinoma Using Megestrol Acetate
NCT00483327, Phase 2, Completed, NYU Langone Health; results first posted 2016-07-01
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Management of Atypical Endometrial Hyperplasia and Endometrial Carcinoma Using Megestrol Acetate. Trials, record NCT00483327. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00483327
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Management of Atypical Endometrial Hyperplasia and Endometrial Carcinoma Using Megestrol Acetate
- NCT number
- NCT00483327
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 31 participants, actual
- Lead sponsor
- NYU Langone Health
- Conditions
- Atypical Endometrial Hyperplasia, Endometrial Carcinoma
- Interventions
- Megestrol Acetate
- First posted
- 2007-06-07
- Last updated
- 2018-04-04
- Results first posted
- 2016-07-01
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Best Pathologic Responses | up to 24 months | Patients are evaluated every 12 weeks while on treatment. The response is evaluated by endometrial biopsy or dilation and curettage (D\&C)/hysteroscopy. Complete response (CR) is defined as endometrial sampling is read as normal or proliferative endometrium. Partial response (PR) is defined as the biopsy sample has changed on the endometrial evaluation scale by at least one level towards normal. Stable disease (SD) is defined as no change in pathology between the index and follow-up sample. Progressive disease (PD) is defined the follow-up sample has changed towards neoplasia on the endometrial evaluation scale by at least one level or imaging is concerning for myometrial invasion or extrauterine disease such that conservative management is no longer medically appropriate. |
| Secondary | Toxicity and Tolerability | up to 36 months | Patients with adverse events (AEs) which were possibly, probably, or definitely related to the treatment. AEs were evaluated according to Common Terminology Criteria for Adverse Events (CTCAE) 3. |
| Secondary | Duration of Response | up to 4 years | For each patient, assessed every 12 weeks during treatment and every 6 months during follow-up. |
| Secondary | Number of Women Who Became Pregnant | up to 3 years after the treatment for each patient |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Best Pathologic Responses | up to 24 months | Patient who were able to complete at least one full course (12 weeks) of treatment | participants | NUMBER |
| SECONDARY | Toxicity and Tolerability | up to 36 months | Any patient with at least one dose of treatment. | participants | NUMBER |
| SECONDARY | Duration of Response | up to 4 years | The original PI for this study is no longer at our institution. Additionally, co-investigator has stated that this data was not collected and therefore not analyzed. This information is not available for reporting as it does not exist. | ||
| SECONDARY | Number of Women Who Became Pregnant | up to 3 years after the treatment for each patient | Only 7 participants in the trial pursued pregnancy. | participants | NUMBER |
Source ClinicalTrials.gov
Results by group38
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Best Pathologic Responses | Megestrol Acetate | Pathologic CR | 17 | participants | |
| Best Pathologic Responses | Megestrol Acetate | Unconfirmed CR | 4 | participants | |
| Best Pathologic Responses | Megestrol Acetate | PR | 6 | participants | |
| Best Pathologic Responses | Megestrol Acetate | SD | 1 | participants | |
| Best Pathologic Responses | Megestrol Acetate | PD | 2 | participants | |
| Toxicity and Tolerability | Grade 1 or 2 | Weight gain | 9 | participants | |
| Toxicity and Tolerability | Grade 3 | Weight gain | 0 | participants | |
| Toxicity and Tolerability | Grade 1 or 2 | Mood alterations | 4 | participants | |
| Toxicity and Tolerability | Grade 3 | Mood alterations | 0 | participants | |
| Toxicity and Tolerability | Grade 1 or 2 | Headache | 5 | participants |
1 to 10 of 38Source ClinicalTrials.gov
See all 38 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Megestrol Acetate | 30 | |
| Overall Study | COMPLETED | Megestrol Acetate | 20 | |
| Overall Study | NOT COMPLETED | Megestrol Acetate | 10 |
Source ClinicalTrials.gov
Adverse events67
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 | Allergic reaction/hypersensitivity (including drug fever) | Immune system disorders | Megestrol Acetate | 1 | 30 | |
| other | Anorexia | Gastrointestinal disorders | Megestrol Acetate | 1 | 30 | |
| other | Confusion | Nervous system disorders | Megestrol Acetate | 1 | 30 | |
| other | Constipation | Gastrointestinal disorders | Megestrol Acetate | 3 | 30 | |
| other | Constitutional Symptoms - Other: thirst | General disorders | Megestrol Acetate | 3 | 30 | |
| other | Cystitis | Renal and urinary disorders | Megestrol Acetate | 1 | 30 | |
| other | Dermatology/Skin - Other: skin peeling | Skin and subcutaneous tissue disorders | Megestrol Acetate | 1 | 30 | |
| other | Diarrhea | Gastrointestinal disorders | Megestrol Acetate | 1 | 30 | |
| other | Distension/bloating, abdominal | Gastrointestinal disorders | Megestrol Acetate | 5 | 30 | |
| other | Dizziness | Nervous system disorders | Megestrol Acetate | 1 | 30 |
1 to 10 of 67Source ClinicalTrials.gov
See all 67 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Megestrol Acetate | ||
| Total, other adverse events | Megestrol Acetate | 29 | 30 |
| Total, serious adverse events | Megestrol Acetate | 1 | 30 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
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.
None in this release.
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/NCT00483327
GET https://conductscience.org/api/trials/v1/NCT00483327/results?page=2