Clinical Study to Evaluate Efficacy and Safety of TAK-385 [amount hidden] Compared With Leuprorelin in Patients With Endometriosis

What Was Tested

The trial (phase 3) is built around Leuprolide for endometriosis.

It had two arms (groups): TAK-385 (experimental) and Leuprorelin acetate (active comparator).

The registry classes the interventions as drug.

More on the Plan

This study consists of screening of approximately 1 to 6 weeks, run-in of approximately 3 to 6 weeks, treatment of 24 weeks, and follow-up of 4 weeks.

After signing the informed consent form, subjects should record their symptoms in the electronic patient diary every day.

During this study, subjects will visit the study center to undergo the designated examinations and evaluations at each visit.

Safety will be assessed throughout the study by monitoring adverse events, vital signs, physical examinations, clinical laboratory tests, 12-lead electrocardiograms (ECG), and assessments of bone mineral density.Subjects will visit the study center to undergo the designated examinations and evaluations at 28 days after final administration.

Who Took Part

The registry lists 335 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 is a premenopausal Japanese woman aged 20 years or older at the time consent is obtained. The participant with endometriosis that falls under one of the following. However, in case of recurrence after surgery, it must be diagnosed again by either of the following. The participant who has been diagnosed with endometriosis by Laparotomy or Laparoscopy. The participant who has been confirmed ovarian chocolate cyst by Magnetic Resonance Imaging (MRI) or ultrasonic examination (vaginal, transabdominal or rectal). The participant agrees to use routinely adequate contraception from signing of informed consent throughout the duration of the study.

The full record lists 9 inclusion and 23 exclusion criteria; among the exclusions: the participant has the following drug usage:; use of the following drugs within 24 weeks:bisphosphonate preparation or other investigational agent; use of the following drugs within 8 weeks:dienogest, oral contraceptive or sex hormone preparations (norethindrone, norethisterone, medroxyprogesterone, estrogen, or other progestins, etc.).

How the Study Was Run

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

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.

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 2019-05-08 with completion listed for 2020-06-12.

It ran at 41 sites in Japan (41).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Change of maximum Visual Analogue Scale (VAS) score for endometriosis associated pelvic pain (time frame: Baseline and the last 28 days of treatment period).

It also tracked 14 secondary outcomes, for example Change of mean VAS score for endometriosis associated pelvic pain, VAS score for endometriosis associated pelvic pain, Change of VAS score for endometriosis associated pelvic pain, VAS score for menstrual pain, Change of VAS score for menstrual pain and VAS score for endometriosis associated pelvic pain outside the menstruation period.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Leuprolide in 335 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.