Endometriosis
Conditions
Interventions
KLH-2109 tablet or KLH-2109 tablet placebo will be orally administered. In addition, leuprorelin acetate or leuprorelin acetate placebo will be administered subcutaneously.
Sponsors
Shimizu Yoshitaka
Eligibility
Sex/Gender
Female
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in the maximum NRS score for pelvic pain during 28 days prior to 12 weeks of the investigational product treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| - Change from baseline in and actual values of the maximum NRS score for pelvic pain every 28 days - Change from baseline in and actual values of the maximum severity score for pelvic pain every 28 days - Change from baseline in and actual values of severity score for temporary pain at each evaluation time point - Change from baseline in and actual values of severity score of objective findings at each evaluation time point - Percent change from baseline in and actual values of ovarian chocolate cyst volume at each evaluation time point - Change from baseline in and actual values of EHP-30 domain score at each evaluation time point - Incidence of adverse events and treatment-related adverse events - Percent change from baseline in bone mineral density at each evaluation time point - Change from baseline in T-score at each evaluation time point | — |
Contacts
Public ContactYoshitaka Shimizu
Kissei Pharmaceutical Co., Ltd.
Outcome results
None listed