Not Yet RecruitingPhase 1

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

30 participantsStarted 2026-08-31

Plain-language 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.

Who can participate

Age range

18 Years – 45 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Concentrations of leuprorelin acetate

Timeframe: Baseline through 70 days post-dose

Concentrations of estradiol

Timeframe: Baseline through 70 days post-dose

Trial details

NCT IDNCT07755956

SponsorZhuhai Huahaikang Pharmaceutical Technology Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-03-31

Contact for this trial

Liang Li

+86 15800440760 liliang@hhkmed.cn

View on ClinicalTrials.gov More Endometriosis trials