Degarelix in the Treatment of Endometriosis Recurrence

Plain-language guide to NCT01712763: phase 3 randomized trial of Leuprolide and Degarelix, endometriosis, 360 participants. Who took part, design and what was measured.

Key Facts

Registry ID: NCT01712763
Phase: phase 3
Status: completed
Start: 2012-11
Completion (planned or actual): 2016-03
Participants: 360 (actual)
Design: randomized, single-blind, 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 Leuprolide and Degarelix for endometriosis.

The long acting GnRH antagonist degarelix will be tested for the treatment of women with endometriosis recurrence compared with classical GnRH analog treatment.

Pain symptom disappearance and disease free time during follow-up will be the outcomes for establishing which medical treatment is the best in endometriosis recurrence treatment.

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

The registry classes the interventions as drug.

More on the Plan

The long acting GnRH antagonist degarelix, which do not have the flare-up effect at the opposite of GnRH agonist and strongly suppress LH secretion and thecal cell activity may show a better effects on endometrial implants than GnRH agonist.

Who Took Part

Enrollment: 360 actual participants took part.

It was open to women only aged from 20 years up to 45 years.

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

Examples of who could join: Women affected by endometriosis showing recurrence of pain symptoms. Previous surgery for endometriosis.

The full record lists 2 inclusion and 1 exclusion criteria; among the exclusions: presence of other systemic diseases.

How the Study Was Run

It was run as a randomized, parallel-group and single-blind study.

The endometriosis participants were allocated by chance, so the Leuprolide group and the comparison group should start out alike.

The Leuprolide group and the comparison group ran side by side rather than switching.

Only one side, usually the endometriosis participants, was kept unaware of whether Leuprolide was given.

Those kept unaware of assignments: participant.

It started in 2012-11 with completion listed for 2016-03.

It ran at 3 sites in Albania (1), Bulgaria (1) and Italy (1).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: disease free time (time frame: 24 months).

It also tracked 1 secondary outcome, for example time of disappearance pain.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Leuprolide and Degarelix in 360 people with endometriosis.

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

More context: the Leuprolide compound page and the Degarelix compound page, Endometriosis research.

Our Notes on the Compounds

Leuprolide: A 9-amino-acid GnRH analog (Lupron, Eligard) that lowers sex-hormone levels with ongoing use; used in prostate cancer, endometriosis and early puberty.

Degarelix: A GnRH antagonist injection (Firmagon) for advanced prostate cancer that lowers testosterone within days without the initial surge seen with agonists.

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.