Endometriosis
Conditions
Keywords
leuprorelin, pharmacokinetics, pharmacodynamics, endometriosis
Brief 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.
Interventions
DRUGLeuprorelin Acetate
Participants will receive a single subcutaneous injection of 3.75 mg HHK001 (investigational leuprorelin acetate preparation).
Participants will receive a single subcutaneous injection of 3.75 mg Enantone (commercially-available leuprorelin acetate preparation).
Sponsors
Zhuhai Huahaikang Pharmaceutical Technology Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Concentrations of leuprorelin acetate | Baseline through 70 days post-dose | Concentrations assessed by pre-specified methods |
| Concentrations of estradiol | Baseline through 70 days post-dose | Concentrations assessed by pre-specified methods |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with Adverse events | Baseline through 70 days post-dose | Adverse events |
| Changes from baseline in overall pain score | Baseline through 70 days post-dose | Pain scores measured on a 0-100 visual analog scale, with higher scores indicating greater pain severity |
Countries
China
Contacts
CONTACTLiang Li
STUDY_DIRECTORFeng
Zhuhai Huahaikang Pharmaceutical Technology Co., Ltd.
Outcome results
None listed