NCT01533532

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
100

participants targeted

Target at P50-P75 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

February 12, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 15, 2012

Completed
Last Updated

May 30, 2014

Status Verified

May 1, 2014

First QC Date

February 12, 2012

Last Update Submit

May 29, 2014

Conditions

Endometriosis

Keywords

Gonadotropin-Releasing Hormone (GnRH) antagonist

Outcome Measures

Primary Outcomes (1)

  • The severity score of the pelvic pain

    12 weeks

Study Arms (4)

KLH-2109, low dose

EXPERIMENTAL
Drug: KLH-2109

KLH-2109, medium dose

EXPERIMENTAL
Drug: KLH-2109

KLH-2109, high dose

EXPERIMENTAL
Drug: KLH-2109

placebo

PLACEBO COMPARATOR
Drug: placebo

Interventions

KLH-2109DRUG
KLH-2109, low dose
placeboDRUG
placebo

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

  • Tatsuro Takei

    Clinical Development Dept.,Kissei Pharmaceutical Co., Ltd.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 12, 2012

First Posted

February 15, 2012

Last Updated

May 30, 2014

Record last verified: 2014-05

Locations

JP(1)