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Liraglutide Plus Megestrol Acetate in Endometrial Atypical Hyperplasia
Plain-language guide to NCT04683237: phase 2, phase 3 randomized trial of Liraglutide, endometriosis. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT04683237
- Phase
- phase 2, phase 3
- Status
- withdrawn
- Start
- 2021-03-20
- Completion (planned or actual)
- 2025-11-30
- Participants
- n/a (actual)
- Design
- randomized, open label (everyone knows who gets what), treatment
- Conditions studied
- Atypical Endometrial Hyperplasia; Obese; Fertility Issues
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
In this phase 2, phase 3 trial, researchers set out to test Liraglutide for endometriosis and hyperparathyroidism.
It had two arms (groups): MA alone (other) and MA+liraglutide (experimental).
The registry classes the interventions as drug.
More on the Plan
By the way, long-term treatment of progesterone has many side effects.
Weight management and lifestyle interventions are clearly written into 2020 uterine NCCN guidelines.
Liraglutide is a GLP-1 receptor agonist (GLP-1RA), which is one of the commonly used hypoglycemic drugs, has been approved for losing weight.
And it is applicable for patients with BMI≥30 kg/m2 or ≥27 kg/m2 combined with one of the following: diabetes, hypertension, hyperlipidemia, sleep apnea.
Who Took Part
It was open to women only aged from 18 years up to 45 years.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: BMI (body mass index) ≥28kg/m2. Consent informed and signed. Pathologically confirmed as endometrial atypical hyperplasia. Have a strong desire to reproduce and ask for fertility preservation or those who insist on keeping the uterus despite no reproductive requirements.
The full record lists 5 inclusion and 9 exclusion criteria; among the exclusions: diagnosed as type 2 diabetes; diabetic ketoacidosis; history of acute pancreatitis.
How the Study Was Run
It was run as a randomized, parallel-group and open-label study.
The endometriosis participants were allocated by chance, so the Liraglutide group and the comparison group should start out alike.
Groups ran in parallel: each of the endometriosis participants stayed in one arm throughout.
Nothing was hidden in this open-label Liraglutide study: the endometriosis participants and staff both knew the treatment.
It started in 2021-03-20 with completion listed for 2025-11-30.
Its stated primary purpose is treatment.
What Was Measured
Researchers chose this as the main measure: Pathological complete response (CR) rates (time frame: From date of randomization until the date of CR, assessed up to 28 weeks).
It also tracked 7 secondary outcomes, for example weight lose, changing of insulin resistance, Time of pathological complete response (CR), safety and side effects, Relapse rates and pregnancy outcomes.
What This Means in Plain Language
Put simply, this is a phase 2, phase 3, randomized trial of Liraglutide in people with endometriosis.
It was withdrawn before enrolling anyone; no results are posted to the registry yet, so nothing here describes outcomes.
More context: the Liraglutide compound page, Endometriosis research, Hyperparathyroidism research.
Our Notes on the Compound
Liraglutide: A once-daily GLP-1 receptor agonist peptide; sold as Victoza for type 2 diabetes and Saxenda for weight management.
Related Pages
Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.