A Long-term Extension Study of TAK-385 in the Treatment of Endometriosis

What Was Tested

In this phase 2 trial, researchers set out to test Leuprolide for endometriosis.

It had five arms (groups): Placebo (placebo comparator), one (experimental), one (experimental), one (experimental) and Leuplin (other).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 397 actual participants took part.

It was open to women only aged from 20 years with no upper age limit.

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

The full record lists 0 inclusion and 4 exclusion criteria; among the exclusions: participants who had an adverse event in tak-385/cct-101 study which makes continued administration of the study drug difficult; participants who became unable to comply with the protocol due to onset of a new disease, symptom, finding, or aggravation of clinical laboratory findings.

How the Study Was Run

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

The endometriosis participants were allocated by chance, so the Leuprolide 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 Leuprolide study: the endometriosis participants and staff both knew the treatment.

It started in 2012-03 with completion listed for 2013-12.

It ran at 69 sites in Japan (69).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Bone Mineral Density (time frame: Up to Week 24). Treatment-emergent Adverse Events (time frame: Up to Week 16). Vital Signs (time frame: Up to Week 24).

It also tracked 2 secondary outcomes, for example Visual Analogue Scale (VAS) Score for Pelvic Pain and VAS Score for Dyspareunia.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Leuprolide in 397 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, Endometriosis research.