Phase Ia Trial of HHK001 Compared With Enantone in Patients With Endometriosis

What Was Tested

The trial (phase 1) is built around Leuprolide for endometriosis.

Both products contain the same active ingredient: leuprorelin acetate.

It had two arms (groups): HHK001 (experimental) and Enantone (active comparator).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 30 planned participants were the target.

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: Voluntarily provide written informed consent;. Female, aged 18-45 years, weight ≥ 40 kg, body mass index 19-28 kg/m²;. The most recent menstrual cycle 21-35 days;. Confirmed diagnosis of endometriosis, and suitable for GnRH agonist;. Cervical cytology test result showing No Intraepithelial Lesion or Malignancy;.

The full record lists 6 inclusion and 8 exclusion criteria; among the exclusions: allergic to gnrh agonists/antagonists, or history of allergies to ≥3 different substances, or active allergic disease;; with contraindications to rescue medication (ibuprofen);; current or past medical history of osteoporosis/osteopenia, pituitary tumor, epilepsy, depressive disorder, thromboembolic events, malignant tumors, unexplained abnormal uterine bleeding;.

How the Study Was Run

Design: randomized, parallel-group and open-label.

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.

Being open-label, the Leuprolide study did not mask who received what.

It started in 2026-08-31 with completion listed for 2027-03-31.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Concentrations of leuprorelin acetate. Concentrations of estradiol.

It also tracked 2 secondary outcomes, for example Number of participants with Adverse events and Changes from baseline in overall pain score.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Leuprolide in 30 people with endometriosis.

Its size is small, so on its own it can only give an early look.

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Leuprolide compound page, Endometriosis research.