Endometriosis
Conditions
Brief 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.
Interventions
DRUGKLH-2109
\- KLH-2109 tablet: Oral administration \- Leuprorelin acetate placebo: Subcutaneous administration
DRUGLeuprorelin acetate
\- KLH-2109 placebo tablet: Oral administration \- Leuprorelin acetate: Subcutaneous administration
Sponsors
Kissei Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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." |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in and actual values of the maximum NRS score for pelvic pain every 28 days | Up to 24 weeks | The NRS score for pelvic pain is an integer scale of 0 to 10 in which the worst daily pain associated with endometriosis will be scored as 0 for "no pain" and 10 for "the worst pain imaginable." |
| Change from baseline in and actual values of the maximum severity score for pelvic pain every 28 days | Up to 24 weeks | The severity of pelvic pain will be assessed on a five-point scale, based on the most severe pain experienced during the day: as score 0 for "None: No pain", score 1 for "Very mild: Not bothersome, score 2 "Mild: Concerned but tolerable (not requiring analgesics), score 3 for "Moderate: Unbearable (requiring analgesics), and score 4 for "Severe: Intolerable despite the use of analgesics. |
| Change from baseline in and actual values of severity score for temporary pain at each evaluation time point | Up to 24 weeks | Pain in bowel movement will be assessed on a five-point scale: as score 0 for "None: No pain", score 1 for "Very mild: Not bothersome", score 2 "Mild: Concerned but tolerable", score 3 for "Moderate: Unbearable to continuously receive stimulation causing the pain", and score 4 for "Severe: Intolerable unless stimulation causing the pain is immediately discontinued". Pain during a pelvic examination will be assessed on a four-point scale: as score 0 for "None: No findings", score 1 for "Mild: Pelvic tenderness", score 2 for "Moderate: Between Mild and Severe", and score 3 for "Severe: Severe pelvic tenderness". Dyspareunia will be assessed on a five-point scale: as score 0 for "None: No pain", score 1 for "Very mild: Not bothersome", score 2 for "Mild: Feeling pain but tolerable", score 3 for "Moderate: Severe pain and discontinuation due to pain", and score 4 for "Severe: Unbearable severe pain and avoidance of sexual intercourse from the beginning". |
| Change from baseline in and actual values of severity score of objective findings at each evaluation time point | Up to 24 weeks | * The severity of the induration of the pouch of Douglas will be assessed on a four-point scale: as score 0 for "None: No findings", score 1 for "Mild: Presence of a small finger-sized induration", score 2 for "Moderate: Between Mild and Severe", and score 3 for "Complete occlusion of the pouch of Douglas with no elasticity". * The severity of the limitation of uterine mobility will be assessed on a four-point scale: as score 0 for "None: No findings", score 1 for "Mild: Limited mobility ", score 2 for "Moderate: Severely limited mobility", and score 3 for "Severely limited mobility, no movement at all". |
| Percent change from baseline in and actual values of ovarian chocolate cyst volume at each evaluation time point | Up to 24 weeks | The presence or absence of ovarian chocolate cyst in both ovaries will be determined by ultrasonography (transvaginal, transabdominal, or transrectal) and the long and short axes of all ovarian chocolate cysts (unit, mm) will be measured. |
| Change from baseline in and actual values of EHP-30 domain score at each evaluation time point | Up to 24 weeks | The EHP-30 is a questionnaire rating scale of 30 items related to QOL in patients with endometriosis on a 5-point scale: "Never", "rarely", "sometimes", "often" and "always". The subjects themselves will evaluate their QOL for the prior month using the EHP-30 questionnaire form and record the results of their assessment in the questionnaire form. |
| Incidence of adverse events and treatment-related adverse events | Up to 24 weeks | — |
| Percent change from baseline in bone mineral density at each evaluation time point | Up to 24 weeks | — |
| Change from baseline in T-score at each evaluation time point | Up to 24 weeks | The "T-score" is an important indicator used in bone density tests. It shows how much an individual's bone density deviates from the average value of young adults (YAM: Young Adult Mean) in terms of standard deviations (SD). Specifically, it is evaluated as follows: * -1.0 or above: Normal * Between -1.0 and -2.5: Low bone mass (osteopenia) * -2.5 or below: Osteoporosis |
Countries
Japan
Contacts
STUDY_DIRECTORYoshitaka Shimizu
Kissei Pharmaceutical Co., Ltd.
Outcome results
None listed