Trial · NCT01968317

Megestrol Acetate Plus Metformin to Megestrol Acetate in Patients With Endometrial Atypical Hyperplasia or Early Stage Endometrial Adenocarcinoma

NCT01968317, Phase 2, Completed, Xiaojun Chen; results first posted 2021-09-13

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Megestrol Acetate Plus Metformin to Megestrol Acetate in Patients With Endometrial Atypical Hyperplasia or Early Stage Endometrial Adenocarcinoma. Trials, record NCT01968317. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01968317

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Megestrol Acetate Plus Metformin to Megestrol Acetate in Patients With Endometrial Atypical Hyperplasia or Early Stage Endometrial Adenocarcinoma
NCT number: NCT01968317
Status: Completed
Phases: Phase 2
Enrollment: 150 participants, actual
Lead sponsor: Xiaojun Chen
Conditions: Endometrial Atypical Hyperplasia, Endometrial Adenocarcinoma
Interventions: Megestrol acetate and metformin, Megestrol acetate
First posted: 2013-10-24
Last updated: 2021-09-14
Results first posted: 2021-09-13

Source ClinicalTrials.gov

Registered outcomes4

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Cumulative CR Rates Within 16 Weeks	16 weeks after initial treatment	The primary objective was to determine whether metformin plus MA would be associated with a higher CR rate at 3 months of treatment compared with MA alone. However, for patients who eventually underwent the first and second hysteroscopies for endometrium evaluation within 16 weeks of the treatment, the cumulative CR rates within 16 weeks (16w-CR) were analysed as first end point instead of the CR rate at 3 months. Complete response was defined as the reversion of AEH/EEC to proliferative or secretory endometrium in pathology.
Secondary	Cumulative CR Rates Within 32 Weeks	32 weeks after initial treatment	One of the secondary objectives was between-group comparisons of the cumulative CR rate at 6 months treatment. However, for patients who eventually underwent the second hysteroscopies for endometrium evaluation within 32 weeks of the treatment, the cumulative CR rates within 32 weeks (32w-CR rates) were analysed as secondary end point instead of the CR rate at 6 months.
Secondary	Recurrence Rate	through study completion, a median time of 33 months	All patients were followed up till February 2019. Statistics of patients who didn't accept hysterectomy and were not lost to follow up were analyzed.
Secondary	Pregnancy Rate	through study completion, a median time of 33 months	All patients were followed up till February 2019. The pregnancy rate was calculated only in women who planned for parenthood immediately after achieving CR.

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	Cumulative CR Rates Within 16 Weeks	16 weeks after initial treatment	In MA+metformin group, 9 cases were excluded in primary analysis for 1 asking for surgery and 8 missing hysteroscopic evaluation.~In MA group, 16 cases were excluded for 1 asking for surgery and 15 missing hysteroscopic evaluation.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Cumulative CR Rates Within 32 Weeks	32 weeks after initial treatment	In MA+metformin group, 6 cases were excluded in this analysis for 3 asking for surgery and 3 missing hysteroscopic evaluation.~In MA group, 8 cases were excluded for 2 asking for surgery and 6 missing hysteroscopic evaluation.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Recurrence Rate	through study completion, a median time of 33 months	In MA+metformin group, 3 cases were excluded in this analysis for surgery, 3 for lost to follow-up, and 1 for still in treatment.~In MA group, 2 cases were excluded for surgery and 6 for lost to follow-up.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Pregnancy Rate	through study completion, a median time of 33 months	In MA+metformin group only 31 cases wanted to have a baby, and that in MA group were 37.	Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group8

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Units
Cumulative CR Rates Within 16 Weeks	Megestrol Acetate and Metformin	23	Participants
Cumulative CR Rates Within 16 Weeks	Megestrol Acetate	12	Participants
Cumulative CR Rates Within 32 Weeks	Megestrol Acetate and Metformin	52	Participants
Cumulative CR Rates Within 32 Weeks	Megestrol Acetate	45	Participants
Recurrence Rate	Megestrol Acetate and Metformin	7	Participants
Recurrence Rate	Megestrol Acetate	6	Participants
Pregnancy Rate	Megestrol Acetate and Metformin	19	Participants
Pregnancy Rate	Megestrol Acetate	15	Participants

Source ClinicalTrials.gov

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Megestrol Acetate and Metformin	76
Overall Study	STARTED	Megestrol Acetate	74
Overall Study	COMPLETED	Megestrol Acetate and Metformin	76
Overall Study	COMPLETED	Megestrol Acetate	74
Overall Study	NOT COMPLETED	Megestrol Acetate and Metformin	0
Overall Study	NOT COMPLETED	Megestrol Acetate	0

Source ClinicalTrials.gov

Adverse events24

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	Weight gain	Endocrine disorders	Megestrol Acetate and Metformin	29	76	29
other	Weight gain	Endocrine disorders	Megestrol Acetate	34	74	34
other	Diarrhea	Gastrointestinal disorders	Megestrol Acetate and Metformin	12	76	12
other	Diarrhea	Gastrointestinal disorders	Megestrol Acetate	3	74	3
other	Increased nocturnal urine	Renal and urinary disorders	Megestrol Acetate and Metformin	15	76	15
other	Increased nocturnal urine	Renal and urinary disorders	Megestrol Acetate	20	74	20
other	Hyperhidrosis	Skin and subcutaneous tissue disorders	Megestrol Acetate and Metformin	10	76	10
other	Hyperhidrosis	Skin and subcutaneous tissue disorders	Megestrol Acetate	10	74	10
other	Breast pain OR Abdominal pain	Vascular disorders	Megestrol Acetate and Metformin	17	76	17
other	Breast pain OR Abdominal pain	Vascular disorders	Megestrol Acetate	20	74	20

1 to 10 of 24Source ClinicalTrials.gov

See all 24 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Megestrol Acetate and Metformin	0	76
Total, all-cause mortality	Megestrol Acetate	0	74
Total, other adverse events	Megestrol Acetate and Metformin	47	76
Total, other adverse events	Megestrol Acetate	46	74
Total, serious adverse events	Megestrol Acetate and Metformin	0	76
Total, serious adverse events	Megestrol Acetate	0	74

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 comparisons6

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Megestrol Acetate and Metformin vs Megestrol Acetate: Cumulative CR Rates Within 32 Weeks	Trial comparisons
Megestrol Acetate and Metformin vs Megestrol Acetate: Pregnancy Rate	Trial comparisons
Megestrol Acetate and Metformin vs Megestrol Acetate: Cumulative CR Rates Within 16 Weeks	Trial comparisons
Megestrol Acetate and Metformin vs Megestrol Acetate: Recurrence Rate	Trial comparisons
Megestrol Acetate and Metformin vs Megestrol Acetate: deaths from any cause	Trial comparisons
Megestrol Acetate and Metformin vs Megestrol Acetate: serious adverse events	Trial comparisons

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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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/NCT01968317

GET https://conductscience.org/api/trials/v1/NCT01968317/events?page=2

API reference For AI assistants