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

Endometriosis

Tagged with

endometriosis

Interventions

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

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