NCT01395940

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of KLH-2109 in patients with endometriosis.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 14, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 18, 2011

Completed
Last Updated

October 30, 2013

Status Verified

October 1, 2013

First QC Date

July 14, 2011

Last Update Submit

October 29, 2013

Conditions

Endometriosis

Keywords

Gonadotropin-Releasing Hormone (GnRH) antagonist

Outcome Measures

Primary Outcomes (1)

  • The severity score of the pelvic pain

    8 weeks

Study Arms (2)

KLH-2109, lower dose

EXPERIMENTAL
Drug: KLH-2109

KLH-2109, higher dose

EXPERIMENTAL
Drug: KLH-2109

Interventions

KLH-2109DRUG
KLH-2109, lower dose

Eligibility Criteria

Age20 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Female patients with endometriosis

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Japan

Tokyo and Other Japanese City, Japan

Location

MeSH Terms

Conditions

Endometriosis

Interventions

linzagolix

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Officials

  • Katsumi Hontani

    Kissei Pharmaceutical Co., Ltd.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

July 14, 2011

First Posted

July 18, 2011

Last Updated

October 30, 2013

Record last verified: 2013-10

Locations

JP(1)