Phase Ia Trial of HHK001 Compared With Enantone in Patients With Endometriosis
NCT07755956
· ctgov
recruiting
phase phase-1
- Enrollment
- 30
- Start
- 2026-08-31
- Completion
- 2027-03-31
- Last updated
- 2026-09-02
- Has results
- False
- Countries
- China
Conditions
Tagged with
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.
License: public-domain-us
· commercial use OK
· attribution required
Courtesy of ClinicalTrials.gov / U.S. National Library of Medicine
Courtesy of ClinicalTrials.gov / U.S. National Library of Medicine