NCT07015268Active, not recruitingPhase 3
A Clinical Study of KLH-2109 in Patients With Endometriosis
Phase III Confirmatory Study of KLH-2109 in Patients With Endometriosis
Source: ClinicalTrials.gov · Last updated 2 Mar 2026
Brief summary (registry, in English)
To verify the non-inferiority of KLH-2109 to leuprorelin acetate in a double-blind manner in terms of efficacy in endometriosis patients with pelvic pain.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 288 (estimated)
- First submitted
- 3 Jun 2025
- Start date
- Jun 2025
- Primary completion date
- Nov 2027
- Lead sponsor
- Kissei Pharmaceutical Co., Ltd.
- Diseases
- Endometriosis
- NCT number
- NCT07015268
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 288
- From Jun 2025 to the primary completion date, Nov 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients with concomitant chronic abdominal pain not attributable to endometriosis (such as irritable bowel syndrome \[IBS\] and interstitial cystitis)
- Patients with concomitant pelvic inflammatory disease or a history of pelvic inflammatory disease within 8 weeks before obtaining informed consent
Other illness
- Patients with undiagnosed abnormal genital bleeding
- Patients with abnormal uterine bleeding or anovulatory bleeding judged to be severe by the principal investigator or subinvestigator
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| - Coordinator of this site? Confirm its status | Multiple Locations | Japan | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.