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Effect GnRH Agonist Administration in Endometriosis Cyst Patients

Plain-language guide to NCT06525155: phase 3 non-randomized trial of Triptorelin, endometriosis, 32 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT06525155
Phase
phase 3
Status
recruiting participants
Start
2024-01-02
Completion (planned or actual)
2025-02
Participants
32 (estimated)
Design
non-randomized, open label (everyone knows who gets what), treatment
Conditions studied
Endometriosis
Results posted
not yet

What This Study Did, in Plain Language

What Was Tested

The trial (phase 3) is built around Triptorelin for endometriosis.

The most common symptom is pelvic pain.

It had two arms (groups): Treatment 1 (experimental) and Treatment 2 (experimental).

The registry classes the interventions as drug.

More on the Plan

They will be asked to come to the hospital every 6-week interval throughout the study period.

The condition of the uterus and cysts will also be evaluated at the time of surgery at week-12.

Who Took Part

32 planned participants were the target.

It was open to women only aged from 18 years up to 40 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Female subjects aged 18 to 40 years. The subjects was diagnosed with endometriosis cysts. Willing to participate in research and sign informed consent before all research-related activities begin. Regular menstruation (within 25 - 35 day intervals) in the last 3 months before the study was conducted.

The full record lists 4 inclusion and 7 exclusion criteria; among the exclusions: the patient used hormonal contraception in the last 3 months prior to the study; using a gnrh agonist within the past 3 months; using the hormone progesterone within the last 3 months.

How the Study Was Run

Design: non-randomized, parallel-group and open-label.

Groups ran in parallel: each of the endometriosis participants stayed in one arm throughout.

Everyone knew when Triptorelin was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2024-01-02 with completion listed for 2025-02.

It ran at 1 site in Indonesia.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Anti Mullerian Hormones (AMH) levels (time frame: Baseline, week-12 (prior to surgery)).

It also tracked 2 secondary outcomes, for example Visual Analogue Scale (VAS) and Estradiol levels.

What This Means in Plain Language

Put simply, this is a phase 3, non-randomized trial of Triptorelin in 32 people with endometriosis.

Its size is small, so on its own it can only give an early look.

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Triptorelin compound page, Endometriosis research.

Our Notes on the Compound

Triptorelin: A 10-amino-acid GnRH analog (Trelstar, Decapeptyl, Triptodur) used in prostate cancer, early puberty and fertility protocols.

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.