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Effect of Elagolix in Symptomatic Endometrioma in Comparison to Combined Oral Contraceptive Pill.

Plain-language guide to NCT07763847: not phased randomized trial of Elagolix (non-peptide), endometriosis, 60 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT07763847
Phase
not phased
Status
completed
Start
2025-04-17
Completion (planned or actual)
2026-04-16
Participants
60 (actual)
Design
randomized, open label (everyone knows who gets what), treatment
Conditions studied
Endometrioma
Results posted
not yet

What This Study Did, in Plain Language

What Was Tested

In this not phased trial, researchers set out to test Elagolix (non-peptide) for endometriosis.

Size of endometrioma (mean diameter) by transvaginal sonography and pain score by VAS will be recorded at the end of 3rd month of therapy.

It had two arms (groups): one (experimental) and one (active comparator).

The registry classes the interventions as drug.

More on the Plan

This study will be conducted in the department of Reproductive endocrinology and infertility, Bangabandhu sheikh Mujib medical university (BSMMU), from the day of IRB approval.

The study population will be women of 18-40 years with symptomatic endometrioma (moderate to severe dysmenorrhea) attending the outpatient department and sonographically diagnosed with endometrioma(2-5cm), fulfilling the inclusion and exclusion criteria.Assessment of endometrioma size will be performed by transvaginal sonography.

The mean of the largest two transverse diameters of each endometrioma will be recorded.

Treatment will be started from the first day of menstruation after the baseline visit and investigation.

Who Took Part

The registry lists 60 actual participants took part.

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: 1\. Diagnosed case of symptomatic endometrioma by transvaginal ultrasound Mean diameter 2-5 cm. Patient present with moderate \& severe dysmenorrhea. 2.Age 18-40 years.

The full record lists 1 inclusion and 1 exclusion criteria; among the exclusions: any contraindications to elagolix such as osteoporosis, severe hepatic impairment, hypersensitivity to elagolix.

How the Study Was Run

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

The endometriosis participants were allocated by chance, so the Elagolix (non-peptide) group and the comparison group should start out alike.

The Elagolix (non-peptide) group and the comparison group ran side by side rather than switching.

Being open-label, the Elagolix (non-peptide) study did not mask who received what.

It started in 2025-04-17 with completion listed for 2026-04-16.

It ran at 1 site in Bangladesh.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Change in size of endometrioma(mean diameter)assessed by transvaginal ultrasound (time frame: 3months). Change in Pain score (measured inVAS) (time frame: 3months).

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Elagolix (non-peptide) in 60 people with endometriosis.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Elagolix (non-peptide) compound page, Endometriosis research.

Our Notes on the Compound

Elagolix (non-peptide): An oral non-peptide GnRH antagonist (Orilissa) approved for endometriosis pain; combined with add-back hormones (Oriahnn) for fibroid bleeding.

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.