Trial · NCT03241888
Megestrol Acetate Plus LNG-IUS in Young Women With Endometrial Atypical Hyperplasia
NCT03241888, Phase 2, Phase 3, Completed, Fudan University
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Megestrol Acetate Plus LNG-IUS in Young Women With Endometrial Atypical Hyperplasia. Trials, record NCT03241888. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03241888
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Megestrol Acetate Plus LNG-IUS in Young Women With Endometrial Atypical Hyperplasia
- NCT number
- NCT03241888
- Status
- Completed
- Phases
- Phase 2, Phase 3
- Enrollment
- 180 participants, actual
- Lead sponsor
- Fudan University
- Conditions
- Atypical Endometrial Hyperplasia
- Interventions
- Megestrol Acetate, Levonorgestrel-releasing Intrauterine System(LNG-IUS)
- First posted
- 2017-08-08
- Last updated
- 2024-09-26
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Pathological response rate | From date of randomization until the date of CR or date of hysterectomy, whichever came first, assessed up to 12 months | the proportion of histologic regression from endometrial atypical hyperplasia to benign endometrium |
| Primary | Pathological response time | From date of randomization until the date of CR or date of hysterectomy, whichever came first, assessed up to 12 months | time of histologic regression from endometrial atypical hyperplasia to benign endometrium |
| 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 | Common side effects from these drugs include weight gain, vaginal spotting and descent of sexuality. Severe side effects include thrombus and diseases related. The investigators will record any mental or body symptoms and evaluate the correlation. |
| Secondary | Rate of relapse | up to 2 years after the treatment for each patient | the proportion of experiencing recurrence after regression |
| Secondary | Rate of pregnancy | up to 2 years after the treatment for each patient | the proportion of getting pregnancy after regression |
| Secondary | Compliance | up to 2 years after the treatment for each patient | The investigators designed a questionnaire to evaluate the compliance through treatment as side effects of oral megestrol acetate may be more common than LNG-IUS. Self Efficacy, physical activity and social support will be scored (1 to 5) and compared among each arm. |
| Other | Economic consequences through study completion | From date of randomization until the date of CR or date of hysterectomy, whichever came first, assessed up to 12 months | The investigators will evaluate whether the combination could shorten the therapeutic period, so that bring economic benefits. |
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.
Papers8
The papers the trial lists on ClinicalTrials.gov.
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/NCT03241888
GET https://conductscience.org/api/trials/v1/NCT03241888/registered