Elagolix Versus Subcutaneous Depot Medroxyprogesterone Acetate for the Treatment of Endometriosis

What Was Tested

The trial (phase 2) is built around Elagolix (non-peptide) for endometriosis.

This study is designed to assess the effects of elagolix versus subcutaneous depot medroxyprogesterone acetate (DMPA-SC; also known as depo-provera) on bone mineral density (BMD) during treatment for 24 weeks with a subsequent 24-week post-treatment period.

It had three arms (groups): one (experimental), one (experimental) and DMPA-SC (active comparator).

The registry classes the interventions as drug.

Who Took Part

252 actual participants took part.

It was open to women only aged from 18 years up to 49 years.

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

Examples of who could join: Be female, aged 18 to 49 years, inclusive. Have had a diagnosis of endometriosis made following laparoscopic visualization of the disease within 8 years of the start of screening with recurrent or persistent symptoms. Have documented negative mammogram results within 12 months of screening if over the age of 40 years. Have a Body Mass Index (BMI) between 18 and 36 kg/m², inclusive. Agree to use two forms of nonhormonal contraception (e.g. condom with spermicide) during the study.

The full record lists 7 inclusion and 21 exclusion criteria; among the exclusions: are currently receiving gonadotropin-releasing hormone (gnrh) agonist, gnrh antagonist, danazol, or have received any of these agents within 6 months of the start of screening; have been nonresponsive to gnrh agonist or antagonist therapy for the management of endometriosis; are currently using hormonal contraception or other forms of hormonal therapy or received such treatment within 1 month of the start of screening.

How the Study Was Run

The set-up was randomized, parallel-group and quadruple-blind.

Because people in this Elagolix (non-peptide) study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

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

Blinding on both sides kept the endometriosis participants and researchers unaware of who received Elagolix (non-peptide).

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2006-12-11 with completion listed for 2008-11-24.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Percent Change From Baseline in Bone Mineral Density of the Spine at Week 24 (time frame: Baseline and week 24). Percent Change From Baseline in Bone Mineral Density of the Femur at Week 24 (time frame: Baseline and week 24).

It also tracked 27 secondary outcomes, for example Percent Change From Baseline in Bone Mineral Density of the Spine at Weeks 12 and 48, Percent Change From Baseline in Bone Mineral Density of the Femur at Weeks 12 and 48, Change From Baseline in N-telopeptide at Weeks 12, 24 and 48, Percentage of Participants With a Response in the Non-menstrual Pelvic Pain Component of the CPSSS at Week 24, Percentage of Participants With a Response in the Dysmenorrhea Component of the CPSSS Over Time and Percentage of Participants With a Response in the Non-menstrual Pelvic Pain Component of the CPSSS Over Time.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Elagolix (non-peptide) in 252 people with endometriosis.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

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