Long-term Use of Mifepristone in the Treatment of Adenomyosis

What Was Tested

In this early phase 1 trial, researchers set out to test Triptorelin.

The design was a prospective, randomized, positive-control, parallel-group, multicenter clinical trial.

It had two arms (groups): mifepristone (experimental) and Triptorelin Acetate (active comparator).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 140 planned participants were the target.

It was open to women only aged from 18 years up to 50 years.

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

Examples of who could join: Female, over 18 years old and not menopausal, agree to tripriline acetate and mifepristone treatment and informed consent. Patients were diagnosed as adenomyosis by postoperative pathology, or those who did not undergo surgery but were diagnosed by auxiliary examination, such as ultrasonography and MRI. Dysmenorrhea with or Without Menorrhagia. Requiring preservation of the uterus or fertility. No other hormonal treatment for Adenomyosis was received in the three months prior to treatment.

The full record lists 6 inclusion and 8 exclusion criteria; among the exclusions: pelvic pain and vaginal bleeding of unknown or non-adenomyosis causes; benign lesions such as endometrial polyp, submucous myoma or suspicious malignant tumors were diagnosed by ultrasonography; receiving other hormone drugs for adenomyosis.

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

The participants were allocated by chance, so the Triptorelin group and the comparison group should start out alike.

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

Nothing was hidden in this open-label Triptorelin study: the participants and staff both knew the treatment.

It started in 2021-12-01 with completion listed for 2023-12-31.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Change from Baseline in Pain on the Visual Analogue Scale (VAS) at week 24 (time frame: Baseline and Week 24).

It also tracked 4 secondary outcomes, for example Pictorial blood loss assessment chart（PBAC）, Change from baseline in uterine size at week 24, Change from baseline in hemoglobin at week 24 and Change from baseline in CA125 at week 24.

What This Means in Plain Language

Put simply, this is a early phase 1, randomized trial of Triptorelin in 140 people.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

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