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Trial · Interventional

CompletedPhase 2Registry data

Efficacy and Safety of TAK-385 in the Treatment of Endometriosis

NCTNCT01458301 (opens ClinicalTrials.gov in a new tab)Other idTAK-385/CCT-101Other idU1111-1123-6890Other idJapicCTI-111588
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 2
Enrollment
487 participants (actual)
Sponsor
Takeda · Industry
Design
Randomized · Quadruple masking
Countries
1 country

Japan

Start
Oct 2011
Primary completion
Aug 2013
Completion
Aug 2013
First posted
24 Oct 2011 (estimated)
Last update posted
25 Feb 2014 (estimated)
Conditions
Endometriosis

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2011201220132014
  1. Ph 2

    Efficacy and Safety of TAK-385 in the Treatment of Endometriosis

    NCT01458301

    Oct 2011 to Aug 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 determine the efficacy and safety of TAK-385, once daily (QD), for 12 weeks in women with endometriosis.

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 outcomes1

Outcomes the sponsor listed as primary.

  1. Score for pelvic pain as measured by the Visual Analogue Scale (VAS)

    Time frame · Week 12 (one menstrual cycle)

    Registry description

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

Secondary outcomes(10)

  1. VAS Score for Pelvic Pain

    Time frame · Up to Week 12.

    Registry description

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

  2. VAS Score for Dyspareunia

    Time frame · Up to Week 12.

    Registry description

    Dyspareunia will be assessed using the VAS as pain evaluation scale

  3. Bone Mineral Density

    Time frame · Up to Week 12.

    Registry description

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

  4. 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)

  5. Vital Signs

    Time frame · Up to Week 12.

    Registry description

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

  6. Body Weight

    Time frame · Up to Week 12.

  7. Electrocardiograms.

    Time frame · Up to Week 12.

  8. Number of Participants with Markedly Abnormal Standard Safety Laboratory Values

    Time frame · Up to Week 24

  9. Serum NTx

    Time frame · Up to Week 12.

    Registry description

    NTx is one of the biochemical bone metabolism markers

  10. Serum BAP

    Time frame · Up to Week 12.

    Registry description

    BAP is one of the biochemical bone metabolism markers

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

9 results

Relugolix, an oral gonadotropin-releasing hormone receptor antagonist, reduces endometriosis-associated pain in a dose-response manner: a randomized, double-blind, placebo-controlled study.

Osuga et al. 2021Fertility and sterilitycited by 67

PMID 32912633DOI 10.1016/j.fertnstert.2020.07.055PUB-32912633

Full text at the publisher9 results
Publisher pageSee results (9)

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. Premenopausal women 2. The participants must have dysmenorrhea and pelvic pain associated with endometriosis. 3. The participant has experienced a regular menstrual cycle. 4. The participant has been diagnosed with endometriosis by method a), b), or c). * Laparotomy * Laparoscopy * Chocolate cyst of the ovary confirmed by MRI Exclusion Criteria: 1. Participants diagnosed with measurable uterine fibroids with the longest diameter of 3 cm or larger 2. Participants with lower abdominal pain due to irritable bowel syndrome or severe interstitial cystitis 3. Participants with a previous or current history of thyroid dysfunction 4. Participants with current or previous history of pelvic inflammatory disease 5. Participants with positive PAP smear test result conducted 6. Participants with a history of panhysterectomy or bilateral oophorectomy 7. Participants judged by investigator to have marked abnormal uterine bleeding or anovulatory bleeding 8. Participants with a previous or current history of a malignant tumor 9. Participants who have been treated with any of the following drugs: anticoagulant drug, antiplatelet drug, tranexamic acid, selective estrogen receptor modulator (SERM), activated vitamin D, other vitamin D, calcitonin, ipriflavone, steroid hormone, vitamin K, teriparatide,or denosumab 10. Participants who have been treated with any of the following drugs: oral contraceptive and sex hormone preparation, gonadotropin-releasing hormone (GnRH) analogue, dienogest, danazol, or aromatase inhibitor 11. Participants who have been treated with bisphosphonate preparation 12. Participants with a previous or current history of hypersensitivity or allergy to Leuplin, synthetic LH-RH, LH-RH derivatives, gelatin-containing formulations or food containing gelatin, or have a previous or current history of severe hypersensitivity or severe allergy to other drugs 13. Participants with non-diagnosable abnormal genital bleeding 14. Participants with a previous or current history of osteoporosis, bone mass loss, or other metabolic bone diseases 15. Participants with clinically significant cardiovascular disease or uncontrollable hypertension 16. Participants judged by investigator to be inappropriate to participate in this study based on the 12-lead electrocardiogram (ECG) findings 17. Participants with active liver disease or jaundice, or with alanine aminotransferase (ALT), aspartate aminotransferase (AST), or total bilirubin \> 1.5 times the upper limit of normal (ULN) in the clinical laboratory tests

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