Study to Compare the Oestradiol Suppression, Clinical Efficacy and Safety of Two Formulations of Triptorelin (Triptorelin Pamoate PR 3-month and Triptorelin Acetate PR 1-month) in Chinese Subjects With Endometriosis

What Was Tested

This registered phase 3 trial tested Triptorelin for endometriosis.

It had two arms (groups): Triptorelin pamoate PR 3-month (experimental) and Triptorelin acetate PR 1-month (active comparator).

The registry classes the interventions as drug.

Who Took Part

300 actual participants took part.

It was open to women only aged from 18 years up to 45 years.

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

Examples of who could join: Female subjects aged from 18 to 45 years inclusive at the date of informed consent. A history of active and regular menstrual cycles of 21 to 35 days (inclusive) in the 6 months prior to the screening visit. A diagnosis of endometriosis, confirmed by laparoscopy or laparotomy within10 years prior to the screening visit. Requires treatment with a Gonadotrophin releasing hormone (GnRH) agonist for a period of 6 months in the judgement of the investigator.

The full record lists 4 inclusion and 4 exclusion criteria; among the exclusions: A current history of undiagnosed abnormal genital bleeding; received treatment with a gnrh agonist within 6 months prior to the screening visit; received any other hormonal treatment within 3 months prior to the screening visit (oestrogens, progestogens, danazol, gestrinone and cyproterone acetate etc).

How the Study Was Run

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

Because people in this Triptorelin study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

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

In this single-blind Triptorelin study one party knew the assignments and the other did not.

Those kept unaware of assignments: outcomes assessor.

It started in 2017-07-28 with completion listed for 2019-05-17.

It ran at 24 sites in China (24).

Its stated primary purpose is treatment.

What Was Measured

It also tracked 7 secondary outcomes, for example Change From Baseline in Endometriosis-associated Pelvic Pain at Weeks 4, 8 and 12, Mean E2 Concentration at Weeks Baseline and 4, 8 and 12, Mean Follicle Stimulating Hormone (FSH) Concentration at Baseline and Weeks 4, 8 and 12, Mean Luteinising Hormone (LH) Concentration at Baseline and Weeks 4, 8 and 12 and Median Time to Menses Recovery.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Triptorelin in 300 people with endometriosis.

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

More context: the Triptorelin compound page, Endometriosis research.