A Clinical Study of KLH-2109 in Patients With Endometriosis
Condition(s) studied
Investigational drug(s) / intervention(s)
KLH-2109: \- KLH-2109 tablet: Oral administration \- Leuprorelin acetate placebo: Subcutaneous administration
Leuprorelin acetate: \- KLH-2109 placebo tablet: Oral administration \- Leuprorelin acetate: Subcutaneous administration
Study summary
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.
Eligibility
Primary outcome measure(s)
- Change from baseline in the maximum NRS score for pelvic pain during 28 days prior to 12 weeks of the investigational product treatment — 12 weeks
NRS score for pelvic pain: The NRS score for pelvic pain is an integer scale of 0 to 10 in which the worst daily pain associated with endometriosis is scored as 0 for "no pain" and 10 for "the worst pain imaginable."
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Research Site | Multiple Locations | Japan |
More Kissei Pharmaceutical Co., Ltd. trials in Japan
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07015268 on ClinicalTrials.gov ↗ ← All trials in Japan