Trial · NCT05316493
Weight Management Plus LNG-IUS/Megestrol Acetate in Endometrial Atypical Hyperplasia
NCT05316493, Phase 2, Phase 3, Recruiting, Xiaojun Chen
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Weight Management Plus LNG-IUS/Megestrol Acetate in Endometrial Atypical Hyperplasia. Trials, record NCT05316493. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05316493
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Weight Management Plus LNG-IUS/Megestrol Acetate in Endometrial Atypical Hyperplasia
- NCT number
- NCT05316493
- Status
- Recruiting
- Phases
- Phase 2, Phase 3
- Enrollment
- 172 participants, estimated
- Lead sponsor
- Xiaojun Chen
- Conditions
- Atypical Endometrial Hyperplasia, Fertility Issues, Overweight and Obesity
- Interventions
- Intensive Lifestyle Intervention (ILI), Megestrol Acetate 160 MG Oral Tablet, Levonorgestrel-Releasing Intrauterine Contraceptive System (Mirena), 52 Mg
- First posted
- 2022-04-07
- Last updated
- 2026-06-04
Source ClinicalTrials.gov
Registered outcomes19
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 recruitment until the date of CR, assessed up to 28 weeks. | The 28-week CR rates will be calculated in four arms |
| Secondary | Pregnancy outcomes | up to 2 years after complete response of the last participant | For participants 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. |
| Secondary | Weight change | From date of recruitment, assessed up to 28 weeks. | The investigators will record body weight every month and calculate its change in kilograms. |
| Secondary | Body composition change | From date of recruitment, assessed up to 28 weeks. | The investigators will detect body composition with InBody machine and calculate changes of the indicated indexes. |
| Secondary | Blood pressures change | From date of recruitment, assessed up to 28 weeks. | Record blood pressures (systolic and diastolic pressures) every 12-16 weeks and count the change during the trial. |
| Secondary | Heart rates change | From date of recruitment, assessed up to 28 weeks. | Record heart rates (beats per minute) every 12-16 weeks and count the change. |
| Secondary | Blood glucose change | From date of recruitment, assessed up to 28 weeks. | Assess fasting glucose levels each 3 to 4 months and calculate changes in mmol/L. |
| Secondary | Blood lipids change | From date of recruitment, assessed up to 28 weeks. | Assess blood lipids levels each 3 to 4 months and calculate changes during the trial. |
| Secondary | Insulin resistance change | Baseline，3months and 6months after enrolled. | Test fasting insulin levels each 3 to 4 months, and count HOMA-IR index (Homeostatic Model Assessment for Insulin Resistance) with fasting insulin and fasting glucose as follow: Insulin (pmol/L)\*glucose (mmol/L)/22.5, and compare the HOMA-IR change during the treatment. |
| Secondary | Ovarian reserve function | From date of recruitment, assessed up to 28 weeks. | Detect serum Anti-Mullerian Hormone (AMH) each 3 or 4 months and calculate its change. |
1 to 10 of 19Source ClinicalTrials.gov
See all 19 registered outcomesOutcomes0
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/NCT05316493
GET https://conductscience.org/api/trials/v1/NCT05316493/registered