Not medical advice. This website is not medical advice, a diagnosis, a match to a trial, or a recommendation to join a study. Listings are plain-English rewrites of public ClinicalTrials.gov records. Whether a site is still enrolling, and whether you qualify, can only be confirmed by the study team and your clinician. Source registry: ClinicalTrials.gov. Editorial rules: methodology.
PlainTrials
RecruitingPhase 1interventionalRules rewrite

Phase 1: testing HHK001 for Endometriosis

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.

Official registry: https://clinicaltrials.gov/study/NCT07755956 · Zhuhai Huahaikang Pharmaceutical Technology Co., Ltd. · enrollment listed as 20

What this phase means

Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are HHK001, or Enantone. The registry lists allocation as randomized. 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.

They plan to enroll about 20 people at 2 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

A Phase Ia Clinical Trial to Compare Pharmacokinetics, Pharmacodynamics, Safety and Preliminary Efficacy of HHK001 Versus Enantone in Patients With Endometriosis

Interventions: HHK001, Enantone

Primary outcome (registry wording): Concentrations of leuprorelin acetate

Who it is for (from inclusion criteria)

  • Ages 18 Years to 45 Years
  • Women only
  • 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

Public study contact (from the registry)

Liang Li

+86 15800440760

liliang@hhkmed.cn

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

2 listed

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NCT04567771 · Official ClinicalTrials.gov record · Mayo Clinic

RecruitingNot a traditional drug phaseChandler, Arizona
Not a traditional drug phase: Observational study, no intervention for Endometriosis

The goal of this watch-and-measure (no experimental treatment required) study is to determine the clinical validity of a deep neural network algorithm that utilizes protein biomarker detection of Endometriosis - "EndoCheck" - as an "aid in diagnosis" for endometriosis and to show validity as a diagnostic test

NCT05245695 · Official ClinicalTrials.gov record · Aspira Women's Health

FAQ about this NCT record

Is NCT07755956 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT07755956?

Phase 1. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT07755956?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary