Leuprorelin-like 3.75 mg injection comparison in endometriosis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 1 trial compares HHK001 to Enantone, both containing leuprorelin acetate, in adults with endometriosis. Participants receive a single 3.75 mg injection and are monitored for pharmacokinetics, pharmacodynamics, safety, and clinical benefit. The study focuses on absorption, bodily response, and potential side effects for the updated formulation. Researchers aim to identify any advantages of HHK001 over Enantone while ensuring participant safety.

Why it matters

Who can join: the full rules

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.

Where it's running

• The Third Xiangya Hospital of Central South University
  Changsha, Hunan, China Recruiting
• Suzhou Municipal Hospital (The Affiliated Suzhou Hospital of Nanjing Medical University)
  Suzhou, Jiangsu, China Recruiting

Study contacts

• Study coordinator: Liang Li
• Email: liliang@hhkmed.cn
• Phone: +86 15800440760

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Comparing different techniques to treat endometriosis

  This study is testing different methods to treat endometriosis, like laser and heat techniques, to see which one works best for relieving pain in women who are already having surgery for the condition.

  Recruiting TriHealth Inc. · Cincinnati, Ohio · NCT06414083

• Postoperative Pain Trajectories After Endometriosis Surgery

  This study tests how pain changes after endometriosis surgery and whether perioperative pain testing can predict who will have ongoing pain.

  Recruiting Centre Hospitalier Universitaire, Amiens · Amiens · NCT07882498

• Imaging endometriosis with a special PET tracer in adult women

  This study tests whether a PET/CT scan using [18F]AlF-FAPI-74 can help detect endometriosis lesions in women who are planning laparoscopy.

  Recruiting Universitaire Ziekenhuizen KU Leuven · Leuven · NCT07876648

• Fiber supplement for digestive symptoms in endometriosis

  A fiber-based supplement is being tested to see if it is safe and helps with gut and vaginal microbiomes and digestive symptoms in women with endometriosis.

  Recruiting LOAM Science · San Francisco, California · NCT07875062

• Stellate ganglion block and dexmedetomidine for better sleep after gynecologic laparoscopy

  The study tests whether giving a preoperative stellate ganglion block plus intraoperative dexmedetomidine improves sleep after laparoscopic gynecologic surgery in women.

  Recruiting The Second People's Hospital of Huai'an · Huai'an, Jiangsu · NCT07860203

• Atypical Endometriosis: Histology, Immunophenotype and Molecular Features

  Researchers will look at how endometriotic tissue that looks atypical under the microscope relates to clinical features and ultrasound findings to better separate benign from potentially atypical lesions.

  Recruiting Casa di Cura Dott. Pederzoli · Peschiera del Garda, Verona · NCT07816133

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.