NCT02778919

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.

Trial Health

87
On Track

Trial Health Score

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

Timeline
Completed

Started May 2016

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

Study Start

First participant enrolled

May 9, 2016

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

May 18, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 20, 2016

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 23, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 23, 2018

Completed
Last Updated

June 4, 2019

Status Verified

June 1, 2019

Enrollment Period

1.9 years

First QC Date

May 18, 2016

Last Update Submit

June 3, 2019

Conditions

Endometriosis

Keywords

Endometriosis

Outcome Measures

Primary Outcomes (1)

  • Change of average Numerical Rating Scale (NRS) score of pelvic pain

    12 weeks

Secondary Outcomes (1)

  • Incidences of adverse events

    24 weeks

Study Arms (6)

KLH-2109, lowest dose

EXPERIMENTAL
Drug: KLH-2109Drug: Placebo

KLH-2109, low dose

EXPERIMENTAL
Drug: KLH-2109Drug: Placebo

KLH-2109, medium dose

EXPERIMENTAL
Drug: KLH-2109Drug: Placebo

KLH-2109, high dose

EXPERIMENTAL
Drug: KLH-2109

Placebo

PLACEBO COMPARATOR

First 12 week period; Placebo, Second 12 week period; randomize to one of the KLH-2109 dose levels

Drug: Placebo

Leuprorelin acetate

OTHER

Active reference

Drug: Leuprorelin acetate

Interventions

KLH-2109DRUG
KLH-2109, high doseKLH-2109, low doseKLH-2109, lowest doseKLH-2109, medium dose
PlaceboDRUG
KLH-2109, low doseKLH-2109, lowest doseKLH-2109, medium dosePlacebo
Leuprorelin acetateDRUG
Leuprorelin acetate

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)

Unknown Facility

Multiple Locations, Japan

Location

MeSH Terms

Conditions

Endometriosis

Interventions

linzagolixLeuprolide

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Gonadotropin-Releasing HormonePituitary Hormone-Releasing HormonesHypothalamic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsNeuropeptidesPeptidesAmino Acids, Peptides, and ProteinsOligopeptidesNerve Tissue ProteinsProteins

Study Design

Study Type
interventional
Phase
phase 2
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 18, 2016

First Posted

May 20, 2016

Study Start

May 9, 2016

Primary Completion

March 23, 2018

Study Completion

March 23, 2018

Last Updated

June 4, 2019

Record last verified: 2019-06

Locations

JP(1)