New pill could ease endometriosis pain without needles
NCT ID NCT07015268
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.
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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.
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- Can AI learn to spot endometriosis and fibroids on ultrasound?