RecruitingPhase 1NCT07755956

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

A Phase Ia Clinical Trial to Compare Pharmacokinetics, Pharmacodynamics, Safety and Preliminary Efficacy of HHK001 Versus Enantone in Patients With Endometriosis


Sponsor

Zhuhai Huahaikang Pharmaceutical Technology Co., Ltd.

Enrollment

30 participants

Start Date

Aug 31, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

The goal of this clinical trial is to find out how the study drug HHK001 compares to Enantone (an approved treatment for endometriosis) when given as a single 3.75 mg injection to participants with endometriosis. Both products contain the same active ingredient: leuprorelin acetate. We will check how the body absorbs and responds to each medicine, monitor possible side effects and treatment benefits. Researchers will compare HHK001 to Enantone to test the advantages of its updated formulation.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 45 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Leuprorelin Acetate and a drug called Leuprorelin Acetate 3.75mg Injection for people with endometriosis. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGLeuprorelin Acetate

Participants will receive a single subcutaneous injection of 3.75 mg HHK001 (investigational leuprorelin acetate preparation).

DRUGLeuprorelin Acetate 3.75mg Injection

Participants will receive a single subcutaneous injection of 3.75 mg Enantone (commercially-available leuprorelin acetate preparation).


Locations(1)

The Third Xiangya Hospital of Central South University

Changsha, Hunan, China

View Full Details on ClinicalTrials.gov

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NCT07755956


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