Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT07015268

A Clinical Study of KLH-2109 in Patients With Endometriosis

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Conditions

Endometriosis Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Research Site

Multiple Locations, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • Patients with undiagnosed abnormal genital bleeding
  • Patients with abnormal uterine bleeding or anovulatory bleeding judged to be severe by the principal investigator or subinvestigator
  • 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

Treatment and study plan

KLH-2109

Drug
  • KLH-2109 tablet: Oral administration
  • Leuprorelin acetate placebo: Subcutaneous administration

Leuprorelin Acetate

Drug
  • KLH-2109 placebo tablet: Oral administration
  • Leuprorelin acetate: Subcutaneous administration

Primary outcomes

  1. Change from baseline in the maximum NRS score for pelvic pain during 28 days prior to 12 weeks of the investigational product treatment

    Time frame: 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 outcomes

  1. Change from baseline in and actual values of the maximum NRS score for pelvic pain every 28 days

    Time frame: 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."

  2. Change from baseline in and actual values of the maximum severity score for pelvic pain every 28 days

    Time frame: 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.

  3. Change from baseline in and actual values of severity score for temporary pain at each evaluation time point

    Time frame: 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".

  4. Change from baseline in and actual values of severity score of objective findings at each evaluation time point

    Time frame: 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".

  5. Percent change from baseline in and actual values of ovarian chocolate cyst volume at each evaluation time point

    Time frame: 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.

  6. Change from baseline in and actual values of EHP-30 domain score at each evaluation time point

    Time frame: 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.

  7. Incidence of adverse events and treatment-related adverse events

    Time frame: Up to 24 weeks

  8. Percent change from baseline in bone mineral density at each evaluation time point

    Time frame: Up to 24 weeks

  9. Change from baseline in T-score at each evaluation time point

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Kissei Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

Phase III Confirmatory Study of KLH-2109 in Patients With Endometriosis

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jun 11, 2025
Registry last updated
Mar 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.