A Long-term Extension Study of TAK-385 in the Treatment of Endometriosis

Takeda

Status and phase: Completed; Phase 2

Conditions: Endometriosis

Treatments: Drug: TAK-385; Drug: Leuprorelin acetate; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01452685

TAK-385/OCT-101

JapicCTI-11589 (Registry Identifier)

U1111-1123-6973 (Registry Identifier)

Details and patient eligibility

About

The purpose of this study is to compare the long term safety and efficacy of TAK-385, once daily (QD) following continued administration in participants who completed a Phase II dose-finding study.

Full description

This study is a long-term extension study for evaluation of the safety and efficacy of TAK-385 following administration for 24 weeks (calculated from Visit 3 in the TAK-385/CCT-101 study) in participants from the Phase II dose-finding study (TAK-385/CCT-101 study).

Enrollment: 397 patients

Sex: Female

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Participants who have completed TAK-385/CCT-101 study

Exclusion criteria

1. Participants who had an adverse event in TAK-385/CCT-101 study which makes continued administration of the study drug difficult
2. Participants who became unable to comply with the protocol due to onset of a new disease, symptom, finding, or aggravation of clinical laboratory findings
3. Participants in whom investigator deems that the study drug shows no efficacy based on the level of pain, menstruation status, and the status of analgesic drug intake in TAK-385/CCT-101 study, or that study continuation represents an unacceptable risk
4. Participants in whom investigator deems that study continuation is difficult due to the occurrence of low estrogen symptoms in TAK-385/CCT-101 study which were attributed to the pharmacological effects of the study drug taking into account the level and frequency of the adverse events etc. as well as the risk-benefit of participants.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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397 participants in 5 patient groups, including a placebo group

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo

TAK-385 10 mg QD

Experimental group

Treatment:

Drug: TAK-385

Drug: TAK-385

Drug: TAK-385

TAK-385 20 mg QD

Experimental group

Treatment:

Drug: TAK-385

Drug: TAK-385

Drug: TAK-385

TAK-385 40 mg QD

Experimental group

Treatment:

Drug: TAK-385

Drug: TAK-385

Drug: TAK-385

Leuplin

Other group

Treatment:

Drug: Leuprorelin acetate