Efficacy and Safety of TAK-385 in the Treatment of Endometriosis

What Was Tested

The trial (phase 2) is built around 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: 487 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.

Examples of who could join: The participant has experienced a regular menstrual cycle. The participant has been diagnosed with endometriosis by method a), b), or c). Chocolate cyst of the ovary confirmed by MRI.

The full record lists 7 inclusion and 17 exclusion criteria; among the exclusions: participants diagnosed with measurable uterine fibroids with the longest diameter of 3 cm or larger; participants with lower abdominal pain due to irritable bowel syndrome or severe interstitial cystitis; participants with a previous or current history of thyroid dysfunction.

How the Study Was Run

Design: randomized, parallel-group and quadruple-blind.

Random assignment meant chance, not the researchers, decided who got Leuprolide and who got the comparison, which limits bias.

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

As a double-blind Leuprolide study, the assignments were hidden from both participants and investigators until the end.

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

It started in 2011-10 with completion listed for 2013-08.

It ran at 69 sites in Japan (69).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Score for pelvic pain as measured by the Visual Analogue Scale (VAS) (time frame: Week 12 (one menstrual cycle)).

It also tracked 10 secondary outcomes, for example VAS Score for Pelvic Pain, VAS Score for Dyspareunia, Bone Mineral Density, Treatment-emergent Adverse Events, Vital Signs and Body Weight.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Leuprolide in 487 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.