Trial · NCT07015268
A Clinical Study of KLH-2109 in Patients With Endometriosis
NCT07015268, Phase 3, Active not recruiting, Kissei Pharmaceutical Co., Ltd.
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Clinical Study of KLH-2109 in Patients With Endometriosis. Trials, record NCT07015268. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07015268
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Clinical Study of KLH-2109 in Patients With Endometriosis
- NCT number
- NCT07015268
- Status
- Active not recruiting
- Phases
- Phase 3
- Enrollment
- 288 participants, estimated
- Lead sponsor
- Kissei Pharmaceutical Co., Ltd.
- Conditions
- Endometriosis
- Interventions
- KLH-2109, Leuprorelin acetate
- First posted
- 2025-06-11
- Last updated
- 2026-03-02
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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 | 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." |
| Secondary | 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. |
| Secondary | 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". |
| Secondary | 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". |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | Incidence of adverse events and treatment-related adverse events | Up to 24 weeks | |
| Secondary | Percent change from baseline in bone mineral density at each evaluation time point | Up to 24 weeks | |
| Secondary | 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 |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07015268
GET https://conductscience.org/api/trials/v1/NCT07015268/registered