NCT07755956RecruitingPhase 1
Phase Ia Trial of HHK001 Compared With Enantone in Patients With Endometriosis
A Phase Ia Clinical Trial to Compare Pharmacokinetics, Pharmacodynamics, Safety and Preliminary Efficacy of HHK001 Versus Enantone in Patients With Endometriosis
Source: ClinicalTrials.gov · Last updated 2 Nov 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- First submitted
- 3 Aug 2026
- Start date
- 31 Oct 2026
- Primary completion date
- 31 Mar 2027
- Lead sponsor
- Zhuhai Huahaikang Pharmaceutical Technology Co., Ltd.
- Diseases
- Endometriosis
- NCT number
- NCT07755956
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 20
- From 31 Oct 2026 to the primary completion date, 31 Mar 2027
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- With contraindications to rescue medication (ibuprofen);
- 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;
Other illness
- Allergic to GnRH agonists/antagonists, or history of allergies to ≥3 different substances, or active allergic disease;
- Current or past medical history of osteoporosis/osteopenia, pituitary tumor, epilepsy, depressive disorder, thromboembolic events, malignant tumors, unexplained abnormal uterine bleeding;
- History of alcohol dependence, drug abuse or illicit substance use;
- Other conditions unsuitable for the trial judged by the investigator.
Who the study is looking for
- 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.
Age in the registry: 18 years to 45 years · Sex: Female · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The Third Xiangya Hospital of Central South University Coordinator of this site? Confirm its status | Changsha | China | Recruiting |
| Suzhou Municipal Hospital (The Affiliated Suzhou Hospital of Nanjing Medical University) Coordinator of this site? Confirm its status | Suzhou | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.