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Trial record 21 of 21 for:    relugolix

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01452685
Recruitment Status : Completed
First Posted : October 17, 2011
Last Update Posted : May 8, 2014
Sponsor:
Information provided by (Responsible Party):
Takeda

Tracking Information
First Submitted Date  ICMJE August 31, 2011
First Posted Date  ICMJE October 17, 2011
Last Update Posted Date May 8, 2014
Study Start Date  ICMJE March 2012
Actual Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 12, 2011)
  • Bone Mineral Density [ Time Frame: Up to Week 24. ]
    Measured by Dual-energy X-ray absorptiometry (DXA)
  • Treatment-emergent Adverse Events [ Time Frame: Up to Week 16 ]
    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 ]
    Vital signs will include body temperature, sitting blood pressure and pulse (bpm).
  • Body Weight [ Time Frame: Up to Week 24 ]
  • Electrocardiograms [ Time Frame: Up to Week 24. ]
  • Laboratory Values [ Time Frame: Up to Week 24 ]
  • Serum NTx [ Time Frame: Up to Week 24 ]
    NTx is one of the biochemical bone metabolism markers
  • Serum BAP [ Time Frame: Up to Week 24 ]
    BAP is one of the biochemical bone metabolism markers
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 12, 2011)
  • Visual Analogue Scale (VAS) Score for Pelvic Pain [ Time Frame: Up to Week 24 ]
    Pelvic pain will be assessed using the VAS as pain evaluation scale
  • VAS Score for Dyspareunia [ Time Frame: Up to Week 24 ]
    Dyspareunia will be assessed using the VAS as pain evaluation scale
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Long-term Extension Study of TAK-385 in the Treatment of Endometriosis
Official Title  ICMJE 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
Brief Summary 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.
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).
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Endometriosis
Intervention  ICMJE
  • 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.
  • 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.
  • 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.
  • 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.
  • 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
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
  • Experimental: TAK-385 10 mg QD
    Intervention: Drug: TAK-385
  • Experimental: TAK-385 20 mg QD
    Intervention: Drug: TAK-385
  • Experimental: TAK-385 40 mg QD
    Intervention: Drug: TAK-385
  • Leuplin
    Intervention: Drug: Leuprorelin acetate
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 7, 2014)
397
Original Estimated Enrollment  ICMJE
 (submitted: October 12, 2011)
450
Actual Study Completion Date  ICMJE December 2013
Actual Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 20 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01452685
Other Study ID Numbers  ICMJE TAK-385/OCT-101
U1111-1123-6973 ( Registry Identifier: WHO )
JapicCTI-11589 ( Registry Identifier: JapicCTI )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Takeda
Study Sponsor  ICMJE Takeda
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: VP Clinical Science Strategy Takeda
PRS Account Takeda
Verification Date May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP