Trial · NCT03675139
MPA Versus Dydrogesterone for Management of Endometrial Hyperplasia Without Atypia
NCT03675139, Phase 3, Completed, Xiaojun Chen
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. MPA Versus Dydrogesterone for Management of Endometrial Hyperplasia Without Atypia. Trials, record NCT03675139. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03675139
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- MPA Versus Dydrogesterone for Management of Endometrial Hyperplasia Without Atypia
- NCT number
- NCT03675139
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 471 participants, actual
- Lead sponsor
- Xiaojun Chen
- Conditions
- Endometrial Hyperplasia Without Atypia
- Interventions
- Medroxyprogesterone Acetate, Dydrogesterone 10 MG
- First posted
- 2018-09-18
- Last updated
- 2023-02-17
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Pathological complete response (CR) rates | From date of randomization until the date of CR, assessed up to 6 months | The CR rates will be calculated after 3 and 6-month therapy based on the following formula: (Number of participants who got CR)/(All enrolled participants). The CR rates will be compared between two therapies (MPA VS dydrogesterone), also between two lesions (SH VS CH). |
| Secondary | Median time of pathological complete response (CR) | From date of randomization until the date of CR, assessed up to 6 months | Median time of histologic regression from endometrial hyperplasia without atypia to normal endometrium, and comparison will be performed between two treatments and two lesions (SH vs CH). |
| Secondary | Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 | up to 2 years after the treatment for each patient | Adverse events related with MPA (Medroxyprogesterone acetate ) or dydrogesterone include acne, irregular bleeding, breast tenderness, decreased scalp hair, difficulty falling or remaining asleep, stomach pain, and weight loss or gain, depression and mood changes. Severe side effects include thrombus and impaired liver and kidney function. The investigators will record any symptoms, evaluate the correlation and count the events. And comparison will be performed between two treatments and two lesions (SH vs CH). |
| Secondary | Relapse rates | up to 2 years after the treatment for each patient | All enrolled patients will be followed up for 2 years. During the following-up period, if patients recur after complete regression, they will be counted and the number of recurrence will be divided by number of patients followed up, then we can get the relapse rates.Comparison will be performed between two treatments and two lesions (SH vs CH). |
| Secondary | Rate of pregnancy | up to 2 years after the treatment for each patient | For patients have a desire for fertility, pregnancies, births and related outcomes will be counted, and the rate of pregnancy will be counted as number of pregnancies/ number of patients trying to fertility in the following period. Comparison will be performed between two treatments and two lesions (SH vs CH). |
| Secondary | Compliance | up to 2 years after the treatment for each patient | The investigators designed a questionnaire to evaluate the compliance through treatment. Comparison will be performed between two treatments and two lesions (SH vs CH). |
| Secondary | cost | From date of randomization until the date of CR, assessed up to 6 months | Treatment-related cost in each patient during the period beginning from randomization to the date of CR.Comparison will be performed between two treatments and two lesions (SH vs CH). |
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.
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/NCT03675139
GET https://conductscience.org/api/trials/v1/NCT03675139/registered