Can a new injection outlast the standard endometriosis treatment?
NCT ID NCT07793162
First seen Aug 28, 2026 · Last updated Aug 28, 2026
Summary
This trial compares a single injection of HHK001, an improved version of the drug leuprorelin, with the standard Enantone injection in 20 women with endometriosis. Researchers measure how the drug moves through the body, its safety, and early signs of effectiveness. The goal is to see if the new formulation offers any advantages, such as a longer-lasting effect, which could mean fewer injections for patients.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- HHK001, an improved formulation of leuprorelin acetate microspheres for injection
- What this could lead to
- If HHK001 works as well as Enantone with a longer-lasting effect, it could offer a more convenient treatment option for endometriosis, potentially reducing the number of injections needed.
- What could go wrong
- This is a small, early-phase trial with only 20 participants, so results may not apply to everyone. The improved formulation might not perform better than the existing drug, and side effects could still be a concern.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 20 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Aug 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 45 years
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Voluntarily sign the informed consent form; 2. Female, aged 18-45 years, body weight \>= 40 kg, body mass index 19-28 kg/m2; 3. The most recent menstrual cycle before screening is 21-35 days; 4. Diagnosed with endometriosis (previously diagnosed by histopathology, or confirmed by ultrasound or magnetic resonance imaging during screening); participants with concomitant adenomyosis or uterine fibroids are eligible; and assessed by the investigator as suitable for GnRH agonist therapy (no other therapeutic interventions allowed from the start of screening \[except rescue medication\]); 5. Cervical cytology (TCT/LCT) result shows no intraepithelial lesion or malignancy (NILM) \[results from this study center within 1 year before screening are acceptable\]; 6. No plans for childbearing, oocyte cryopreservation, or oocyte donation from the start of screening until 3 months after dosing, and agreement to use effective contraception (complete abstinence, barrier methods, or non-medicated intrauterine device; no contraceptive medications allowed). Exclusion Criteria: 1. Allergy to GnRH agonists/antagonists (e.g., leuprorelin, triptorelin, goserelin, cetrorelix, ganirelix, degarelix), or a history of allergy to \>= 3 substances, or currently in an allergic state; 2. Contraindications to the rescue medication (ibuprofen) (e.g., allergy to non-steroidal anti-inflammatory drugs, active peptic ulcer, or other conditions assessed by the investigator as contraindications); 3. Current or previous osteoporosis/osteopenia, pituitary tumor, epilepsy, depressive disorder, thromboembolic events (e.g., myocardial infarction, cerebral infarction, deep vein thrombosis, pulmonary embolism), malignant tumors, abnormal uterine bleeding of unknown nature, or other conditions assessed by the investigator as unsuitable for this trial (e.g., diseases with acute/chronic pain, coagulation disorders, mental disorders, and various severe or unstable diseases); 4. Receipt of GnRH agonists/antagonists (including investigational products in clinical trials) within 12 weeks before screening or during screening; 5. Receipt of medications that may significantly affect hypothalamic-pituitary-gonadal axis hormone levels within 4 weeks before screening or during screening, such as estrogens/progestins/androgens and their derivatives/receptor modulators, aromatase inhibitors, etc.; 6. Receipt of traditional Chinese medicine for endometriosis within 4 weeks before screening or during screening; 7. Last treatment with an investigational product (drug or device) in a previous clinical trial \<= 4 weeks before screening (or \<= 12 weeks or 5 half-lives for therapeutic biological products, whichever is longer), or not yet withdrawn from another interventional clinical trial before enrollment; 8. Previous surgery of the hypothalamus or pituitary gland; 9. Any surgery within 4 weeks before screening or during screening (except endometriosis-related surgery), or planned surgery or invasive procedures after enrollment; 10. History of miscarriage within 4 weeks before screening or during screening; 11. Screening examination results meeting any of the following: systolic blood pressure \>= 160 mmHg, diastolic blood pressure \>= 100 mmHg, platelet count \<= 90 x 10\^9/L, hemoglobin \<= 80 g/L, alanine aminotransferase \>= 2 x ULN, aspartate aminotransferase \>= 2 x ULN, total bilirubin \>= 1.5 x ULN, serum creatinine \>= 1.5 x ULN, glycated hemoglobin (HbA1c) \>= 8.0%, Z-score \<= -2.0 at any site on dual-energy X-ray absorptiometry, hepatitis B surface antigen positive with HBV DNA \> ULN, hepatitis C virus antibody positive, human immunodeficiency virus antibody positive, or positive syphilis serology; 12. Abnormal skin at the proposed injection sites (left and right upper arms) that affects dosing or assessment of injection site reactions (e.g., skin lesions, rashes); 13. Acute blood loss or blood donation \>= 400 mL within 4 weeks before screening or during screening, or planned blood donation after enrollment; 14. History of blood phobia, needle phobia, or difficult venous blood collection; 15. History of alcohol dependence, drug abuse, or drug addiction; 16. Pregnancy or lactation, or positive pregnancy test; 17. Other conditions assessed as unsuitable for participation in this trial.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
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