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Can a new formulation of an endometriosis drug match the standard?

NCT ID NCT07755956

Disease control Sponsor: Zhuhai Huahaikang Pharmaceutical Technology Co., Ltd. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 10, 2026 · Last updated Sep 03, 2026 · Updated 3 times

Summary

This trial compares HHK001, an investigational version of leuprorelin acetate, to Enantone, an approved treatment for endometriosis. Both contain the same active ingredient, but HHK001 uses an updated formulation. The study will enroll 30 women aged 18-45 with endometriosis, who will receive a single injection of either drug. Researchers will measure how the body absorbs each medicine, monitor side effects, and track changes in pain scores to see if HHK001 offers any advantages.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
leuprorelin acetate (HHK001, an investigational formulation)
What this could lead to
If HHK001 works as well as Enantone but with a better formulation, it could offer a new treatment option for endometriosis with similar benefits and possibly fewer side effects.
What could go wrong
This is an early-phase trial with only 30 participants, so results may not apply broadly. The drug may not match Enantone's effectiveness or safety, and side effects like hot flashes or bone density changes are possible.

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

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 30 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Mar 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 45 years

Sex

Female participants only

Healthy volunteers

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

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

endometriosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Endometriosis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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.

Contacts and locations

Locations

  • The Third Xiangya Hospital of Central South University

    RECRUITING

    Changsha, Hunan, 410013, China

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