Late Phase II Clinical Study of KLH-2109 in Patients With Endometriosis

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02778919

Enrollment

Unknown

Registered

2016-05-20

Start date

2016-05-09

Completion date

2018-03-23

Last updated

2019-06-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endometriosis

Keywords

Endometriosis

Brief summary

The purpose of this study is to evaluate the efficacy, safety, and dose-response relationship of KLH-2109 compared to placebo in Japanese patients with endometriosis.

Interventions

DRUGLeuprorelin acetate

DRUGKLH-2109

DRUGPlacebo

Eligibility

Sex/Gender

FEMALE

Age

20 Years to No maximum

Healthy volunteers

Inclusion criteria

* Female patients with endometriosis

Exclusion criteria

* Patients with clinically significant hepatic, renal, or cardiovascular dysfunction

Design outcomes

Primary

Measure	Time frame
Change of average Numerical Rating Scale (NRS) score of pelvic pain	12 weeks

Secondary

Measure	Time frame
Incidences of adverse events	24 weeks

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026