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

ConditionEndometriosis
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexFemale
Age18-45
SponsorZhuhai Huahaikang Pharmaceutical Technology Co., Ltd.

About this trial

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 criteria

Qualifiers

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;

Disqualifiers

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;

Trial design

Treatments tested in this trial

  • Leuprorelin Acetate
  • Leuprorelin Acetate 3.75mg Injection

Treatment groups

30 Participants
are divided into 2 treatment groups

Locations

This trial has no locations