A Phase Ia Trial Comparing the Pharmacokinetics/Pharmacodynamics, Safety, and Preliminary Efficacy of HHK001 and Enantone in Patients With Endometriosis

What Was Tested

In this phase 1 trial, researchers set out to test Leuprolide for endometriosis.

Approximately 20 patients will be enrolled and randomized in a 1:1 ratio to receive a single subcutaneous injection of HHK001 or Enantone.

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

The registry classes the interventions as drug.

More on the Plan

Study Design and Population: This is a single-center, randomized, open-label, parallel-group, Phase Ia study in patients with endometriosis.

Approximately 20 patients will be randomized in a 1:1 ratio to the HHK001 group or the Enantone group (10 participants per group).

Who Took Part

20 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 sign the informed consent form;. Female, aged 18-45 years, body weight \>= 40 kg, body mass index 19-28 kg/m2;. The most recent menstrual cycle before screening is 21-35 days;. Cervical cytology (TCT/LCT) result shows no intraepithelial lesion or malignancy (NILM) \[results from this study center within 1 year before screening are acceptable\];.

The full record lists 6 inclusion and 17 exclusion criteria; among the exclusions: contraindications to the rescue medication (ibuprofen) (e.g., allergy to non-steroidal anti-inflammatory drugs, active peptic ulcer, or other conditions assessed by the investigator as contraindications);; receipt of gnrh agonists/antagonists (including investigational products in clinical trials) within 12 weeks before screening or during screening;; receipt of traditional chinese medicine for endometriosis within 4 weeks before screening or during screening;.

How the Study Was Run

It was run as a randomized, parallel-group and open-label study.

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

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

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

It started in 2026-08-31 with completion listed for 2027-12-31.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Maximum Plasma Concentration (Cmax) of Leuprorelin. Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUC0-t) of Leuprorelin. Area Under the Curve From Time Zero Extrapolated to Infinity (AUC0-inf) of Leuprorelin.

It also tracked 31 secondary outcomes, for example Time to Maximum Plasma Concentration (Tmax) of Leuprorelin, Elimination Half-Life (t1/2) of Leuprorelin, Apparent Clearance (CL/F) of Leuprorelin, Apparent Volume of Distribution (Vd/F) of Leuprorelin, Area Under the Curve From Time Zero to 7 Days (AUC0-7d) of Leuprorelin and Area Under the Curve From Time Zero to 28 Days (AUC0-28d) of Leuprorelin.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Leuprolide in 20 people with endometriosis.

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

Its status is not yet recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Leuprolide compound page, Endometriosis research.