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Trial · Interventional

CompletedPhase 2Registry data

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

NCTNCT01452685 (opens ClinicalTrials.gov in a new tab)Other idTAK-385/OCT-101Other idU1111-1123-6973Other idJapicCTI-11589
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 2
Enrollment
397 participants (actual)
Sponsor
Takeda · Industry
Design
Randomized · Open label (no masking)
Countries
1 country

Japan

Start
Mar 2012
Primary completion
Dec 2013
Completion
Dec 2013
First posted
17 Oct 2011 (estimated)
Last update posted
8 May 2014 (estimated)
Conditions
Endometriosis

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
201220132014
  1. Ph 2

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

    NCT01452685

    Mar 2012 to Dec 2013

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • PlaceboDrug
  • TAK-385Drug
  • TAK-385Drug
  • TAK-385Drug
  • Leuprorelin acetateDrug

Arms5

  • Placebo comparator

    Placebo

  • Experimental

    TAK-385 10 mg QD

  • Experimental

    TAK-385 20 mg QD

  • Experimental

    TAK-385 40 mg QD

  • Other

    Leuplin

Primary outcomes8

Outcomes the sponsor listed as primary.

  1. Bone Mineral Density

    Time frame · Up to Week 24.

    Registry description

    Measured by Dual-energy X-ray absorptiometry (DXA)

  2. Treatment-emergent Adverse Events

    Time frame · Up to Week 16

    Registry description

    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)

  3. Vital Signs

    Time frame · Up to Week 24

    Registry description

    Vital signs will include body temperature, sitting blood pressure and pulse (bpm).

  4. Body Weight

    Time frame · Up to Week 24

  5. Electrocardiograms

    Time frame · Up to Week 24.

  6. Laboratory Values

    Time frame · Up to Week 24

  7. Serum NTx

    Time frame · Up to Week 24

    Registry description

    NTx is one of the biochemical bone metabolism markers

  8. Serum BAP

    Time frame · Up to Week 24

    Registry description

    BAP is one of the biochemical bone metabolism markers

Secondary outcomes(2)

  1. Visual Analogue Scale (VAS) Score for Pelvic Pain

    Time frame · Up to Week 24

    Registry description

    Pelvic pain will be assessed using the VAS as pain evaluation scale

  2. VAS Score for Dyspareunia

    Time frame · Up to Week 24

    Registry description

    Dyspareunia will be assessed using the VAS as pain evaluation scale

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2021

5 results

Relugolix, an oral gonadotropin-releasing hormone (GnRH) receptor antagonist, in women with endometriosis-associated pain: phase 2 safety and efficacy 24-week results.

Osuga et al. 2021BMC women's healthcited by 33

PMID 34154590PMC8218467DOI 10.1186/s12905-021-01393-3PUB-34154590

CC BY5 results
Download PDFSee results (5)

Eligibility

Who could join, as posted.

Sex
Female
Age
from 20 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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.

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