A Phase 3 Study to Evaluate the Efficacy and Safety of Relugolix (TAK-385) [amount hidden] Compared With Leuprorelin in the Treatment of Uterine Fibroids

What Was Tested

The trial (phase 3) is built around Leuprolide.

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

The registry classes the interventions as drug.

More on the Plan

The drug tested in this study was called Relugolix (TAK-385).

Relugolix was tested to treat people who had uterine fibroids.

The study enrolled 281 patients.

Participants received relugolix placebo and leuprorelin acetate placebo in run in period for 3 to 6 weeks.

Who Took Part

281 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: In the opinion of the investigator or subinvestigator, the participant is capable of understanding and complying with protocol requirements. The participant signs and dates a written, informed consent form prior to the initiation of any study procedures. The participant is a premenopausal Japanese woman. The participant is aged 20 years or older on the day of signing and dating the informed consent form. The participant has 1 or more measurable noncalcified myomas with the longest diameter of ≥ 3 cm confirmed by transvaginal ultrasound.

The full record lists 12 inclusion and 25 exclusion criteria; among the exclusions: the participant has received relugolix (including placebo) in a previous clinical study; the participant has a previous or current history of blood disorders (eg, thalassemia, sickle cells anemia, folic-acid deficiency, and coagulopathy), excluding (latent) iron-deficiency anemia; the participant has a known history of severe hypersensitivity or severe allergy to sanitary goods.

How the Study Was Run

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

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

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

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 2016-03-05 with completion listed for 2017-05-17.

It ran at 25 sites in Japan (25).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Percentage of Participants With Total PBAC Score of <10 From Week 6 to 12 (time frame: Week 6 to 12).

It also tracked 16 secondary outcomes, for example Percentage of Participants With Total PBAC Score of <10 From Week 2 to 6, Percentage of Participants With Total PBAC Score of <10 From Week 18 to 24, Percent Change From Baseline in Myoma Volumes at Weeks 2, 4, 8, 12 and 24, Percent Change From Baseline in Uterine Volumes at Weeks 2, 4, 8, 12 and 24, Change From Baseline in Hemoglobin at Weeks 4, 8, 12, 16, 20, 24 and Follow up and Numerical Rating Scale (NRS) Score.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Leuprolide in 281 people.

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

More context: the Leuprolide compound page, all human trials.