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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Takeda
ClinicalTrials.gov Identifier:
NCT01452685
First received: August 31, 2011
Last updated: May 7, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention Phase
Endometriosis
Drug: Placebo
Drug: TAK-385
Drug: Leuprorelin acetate
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II, Multicenter, Long-term Extension Study to Compare the Safety and Efficacy of TAK-385 (10, 20, and 40 mg) Following Oral Administration for 12 Weeks or More in the Treatment of Endometriosis

Resource links provided by NLM:


Further study details as provided by Takeda:

Primary Outcome Measures:
  • Bone Mineral Density [ Time Frame: Up to Week 24. ] [ Designated as safety issue: Yes ]
    Measured by Dual-energy X-ray absorptiometry (DXA)

  • Treatment-emergent Adverse Events [ Time Frame: Up to Week 16 ] [ Designated as safety issue: Yes ]
    Treatment-emergent adverse events are defined as any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through the last visit (Week 16)

  • Vital Signs [ Time Frame: Up to Week 24 ] [ Designated as safety issue: Yes ]
    Vital signs will include body temperature, sitting blood pressure and pulse (bpm).

  • Body Weight [ Time Frame: Up to Week 24 ] [ Designated as safety issue: Yes ]
  • Electrocardiograms [ Time Frame: Up to Week 24. ] [ Designated as safety issue: Yes ]
  • Laboratory Values [ Time Frame: Up to Week 24 ] [ Designated as safety issue: Yes ]
  • Serum NTx [ Time Frame: Up to Week 24 ] [ Designated as safety issue: Yes ]
    NTx is one of the biochemical bone metabolism markers

  • Serum BAP [ Time Frame: Up to Week 24 ] [ Designated as safety issue: Yes ]
    BAP is one of the biochemical bone metabolism markers


Secondary Outcome Measures:
  • Visual Analogue Scale (VAS) Score for Pelvic Pain [ Time Frame: Up to Week 24 ] [ Designated as safety issue: No ]
    Pelvic pain will be assessed using the VAS as pain evaluation scale

  • VAS Score for Dyspareunia [ Time Frame: Up to Week 24 ] [ Designated as safety issue: No ]
    Dyspareunia will be assessed using the VAS as pain evaluation scale


Enrollment: 397
Study Start Date: March 2012
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo Drug: Placebo
TAK-385 placebo-matching tablets, orally, once daily and leuprorelin acetate placebo injection, subcutaneously, once every 4 weeks for up to 12 weeks.
Experimental: TAK-385 10 mg QD Drug: TAK-385
TAK-385 10 mg, tablets, orally, once daily and leuprorelin acetate placebo injection, subcutaneously, once every 4 weeks for up to 12 weeks.
Experimental: TAK-385 20 mg QD Drug: TAK-385
TAK-385 20 mg, tablets orally, once daily and leuprorelin acetate placebo injection, subcutaneously, once every 4 weeks for up to 12 weeks.
Experimental: TAK-385 40 mg QD Drug: TAK-385
TAK-385 40 mg, tablets, orally, once daily and leuprorelin acetate placebo injection, subcutaneously, once every 4 weeks for up to 12 weeks.
Leuplin Drug: Leuprorelin acetate
TAK-385 placebo-matching tablets, orally, once daily and leuprorelin acetate 3.75 mg injection, subcutaneously, once every 4 weeks for up to 12 weeks
Other Name: Leuplin

Detailed 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).

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01452685

  Show 69 Study Locations
Sponsors and Collaborators
Takeda
Investigators
Study Director: VP Clinical Science Strategy Takeda
  More Information

No publications provided

Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT01452685     History of Changes
Other Study ID Numbers: TAK-385/OCT-101, U1111-1123-6973, JapicCTI-11589
Study First Received: August 31, 2011
Last Updated: May 7, 2014
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Takeda:
Drug Therapy

Additional relevant MeSH terms:
Endometriosis
Genital Diseases, Female
Leuprolide
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Antineoplastic Agents, Hormonal
Antineoplastic Agents

ClinicalTrials.gov processed this record on September 22, 2014