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.
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;
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;
Parallel
Leuprorelin Acetate
DrugParticipants will receive a single subcutaneous injection of 3.75 mg HHK001 (investigational leuprorelin acetate preparation).
Leuprorelin Acetate 3.75mg Injection
DrugParticipants will receive a single subcutaneous injection of 3.75 mg Enantone (commercially-available leuprorelin acetate preparation).
Concentrations of leuprorelin acetate
Concentrations assessed by pre-specified methods
Concentrations of estradiol
Concentrations assessed by pre-specified methods
Number of participants with Adverse events
Adverse events
Changes from baseline in overall pain score
Pain scores measured on a 0-100 visual analog scale, with higher scores indicating greater pain severity
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