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New pill could ease endometriosis pain without needles

NCT ID NCT07015268

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This Phase 3 trial tests an oral drug called KLH-2109 for pelvic pain in 288 women with endometriosis. Participants receive either KLH-2109 or a standard injection (leuprorelin acetate) for 12 weeks. The goal is to see if the new pill works as well as the injection in reducing daily pain scores.

What this could mean

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

Active substance
KLH-2109 (oral tablet)
What this could lead to
If successful, KLH-2109 could offer a new oral option to ease pelvic pain from endometriosis, potentially with fewer side effects than current injections.
What could go wrong
This is a mid-stage trial with 288 participants, so results may not apply to everyone. The drug is compared to an existing treatment, and it may not prove as effective or could have unexpected side effects.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 288 people

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

Started

Jun 2025

Expected to finish

Nov 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 years and older

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: Premenopausal women aged 18 years or older (at the time of consent) with endometriosis who meet any of the following inclusion criteria.: * A diagnosis of endometriosis by laparotomy or laparoscopy within 5 years before the start of the screening period; * Ovarian chocolate cyst confirmed by MRI performed within 1 year before the start of the screening period or ultrasonography (transvaginal, transabdominal, or transrectal) carried out at the start of the screening period; or * Any of induration of the pouch of Douglas, limitation of uterine mobility, and pelvic tenderness based on the result of pelvic/rectal examination at the start of the screening period and a diagnosis of clinical endometriosis Exclusion Criteria: 1. Patients with undiagnosed abnormal genital bleeding 2. Patients with abnormal uterine bleeding or anovulatory bleeding judged to be severe by the principal investigator or subinvestigator 3. Patients with concomitant chronic abdominal pain not attributable to endometriosis (such as irritable bowel syndrome \[IBS\] and interstitial cystitis) 4. Patients with concomitant pelvic inflammatory disease or a history of pelvic inflammatory disease within 8 weeks before obtaining informed consent

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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.

Contacts and locations

Locations

  • Research Site

    Multiple Locations, Japan

More trials for these conditions

Other studies related to the condition(s) this trial covers.