RECRUITING Phase 1 ClinicalTrials.gov

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

Sponsor: Zhuhai Huahaikang Pharmaceutical Technology Co., Ltd. • ClinicalTrials.gov ID: NCT07755956

Registry updated: 2026-09-02

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Description

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.

Interventions

Leuprorelin Acetate (Drug)
Participants will receive a single subcutaneous injection of 3.75 mg HHK001 (investigational leuprorelin acetate preparation).
Leuprorelin Acetate 3.75mg Injection (Drug)
Participants will receive a single subcutaneous injection of 3.75 mg Enantone (commercially-available leuprorelin acetate preparation).

Eligibility criteria

Inclusion Criteria: * 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; * No plan for pregnancy, egg cryopreservation or donation, and agree to use effective contraception from screening through 3 months after dosing. Exclusion Criteria: * 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; * Received any GnRH agonist/antagonist within 12 weeks before screening; * Received medications that may significantly alter hypothalamic-pituitary-gonadal axis hormone levels within 4 weeks before screening; * History of miscarriage within 4 weeks before screening; * History of alcohol dependence, drug abuse or illicit substance use; * Other conditions unsuitable for the trial judged by the investigator.

Conditions

Endometriosis

Locations

The Third Xiangya Hospital of Central South University — Changsha, Hunan, China

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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