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Clinical Study to Evaluate Efficacy and Safety of TAK-385 40 mg Compared With Leuprorelin in Patients With 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: NCT03931915
Recruitment Status : Active, not recruiting
First Posted : April 30, 2019
Last Update Posted : July 9, 2020
Sponsor:
Information provided by (Responsible Party):
ASKA Pharmaceutical Co., Ltd.

Tracking Information
First Submitted Date  ICMJE April 24, 2019
First Posted Date  ICMJE April 30, 2019
Last Update Posted Date July 9, 2020
Actual Study Start Date  ICMJE May 8, 2019
Estimated Primary Completion Date March 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 26, 2019)
Change of maximum Visual Analogue Scale (VAS) score for endometriosis associated pelvic pain [ Time Frame: Baseline and the last 28 days of treatment period ]
Pelvic pain will be assessed using the VAS (0 - 100) as pain evaluation scale
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 26, 2019)
  • Change of mean VAS score for endometriosis associated pelvic pain [ Time Frame: Baseline and the last 28 days of treatment period ]
    Pelvic pain will be assessed using the VAS (0 - 100) as pain evaluation scale
  • VAS score for endometriosis associated pelvic pain [ Time Frame: Up to Week 24 ]
    Pelvic pain will be assessed using the VAS (0 - 100) as pain evaluation scale
  • Change of VAS score for endometriosis associated pelvic pain [ Time Frame: Baseline and up to Week 24 ]
    Pelvic pain will be assessed using the VAS (0 - 100) as pain evaluation scale
  • VAS score for menstrual pain [ Time Frame: Up to Week 24 ]
    Menstrual pain will be assessed using the VAS (0 - 100) as pain evaluation scale
  • Change of VAS score for menstrual pain [ Time Frame: Baseline and up to Week 24 ]
    Menstrual pain will be assessed using the VAS (0 - 100) as pain evaluation scale
  • VAS score for endometriosis associated pelvic pain outside the menstruation period [ Time Frame: Up to Week 24 ]
    Pelvic pain outside the menstruation period will be assessed using the VAS (0 - 100) as pain evaluation scale
  • Change of VAS score for endometriosis associated pelvic pain outside the menstruation period [ Time Frame: Baseline and up to Week 24 ]
    Pelvic pain outside the menstruation period will be assessed using the VAS (0 - 100) as pain evaluation scale
  • VAS score for dyspareunia [ Time Frame: Up to Week 24 ]
    Dyspareunia will be assessed using the VAS (0 - 100) as pain evaluation scale
  • Change of VAS score for dyspareunia [ Time Frame: Baseline and up to Week 24 ]
    Dyspareunia will be assessed using the VAS (0 - 100) as pain evaluation scale
  • Adverse event [ Time Frame: Up to Week 28 ]
  • Bone mineral density [ Time Frame: Up to Week 24 ]
  • Serum concentrations of NTx (N-telopeptide) [ Time Frame: Up to Week 24 ]
  • Serum concentrations of BAP (Bone alkaline phosphatase) [ Time Frame: Up to Week 24 ]
  • Period from the last dose of study drug to return of menstrual cycles [ Time Frame: From Week 24 to Week 28 ]
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 Clinical Study to Evaluate Efficacy and Safety of TAK-385 40 mg Compared With Leuprorelin in Patients With Endometriosis
Official Title  ICMJE Phase III Clinical Study to Evaluate Efficacy and Safety of TAK-385 40 mg Compared With Leuprorelin in Patients With Endometriosis
Brief Summary The objective is to evaluate the efficacy and safety of TAK-385 40 mg orally administrated once daily for 24 weeks compared with Leuprorelin [once/4 weeks, 3.75 or 1.88 mg subcutaneously (SC)/time] in patients with endometriosis.
Detailed Description This study is a phase III, multicenter, randomized, double-blind, parallel-group study to investigate the efficacy and safety of TAK-385 40 mg once daily compared with leuprorelin (once/4 weeks, 3.75 or 1.88 mg SC/time) in premenopausal subjects ≥ 20 years of age with endometriosis. 320 women with endometriosis will be enrolled in the study. This study consists of screening of approximately 1 to 6 weeks, run-in of approximately 3 to 6 weeks, treatment of 24 weeks, and follow-up of 4 weeks. After signing the informed consent form, subjects should record their symptoms in the electronic patient diary every day. During run-in period, daily data will be collected in the electronic patient diary for calculation of the baseline values for the efficacy evaluation.Following run-in period, subjects will receive investigational products (TAK-385 + leuprorelin placebo or TAK-385 placebo + leuprorelin) under double blind. During this study, subjects will visit the study center to undergo the designated examinations and evaluations at each visit. Safety will be assessed throughout the study by monitoring adverse events, vital signs, physical examinations, clinical laboratory tests, 12-lead electrocardiograms (ECG), and assessments of bone mineral density.Subjects will visit the study center to undergo the designated examinations and evaluations at 28 days after final administration.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Endometriosis
Intervention  ICMJE
  • Drug: TAK-385
    TAK-385 40 mg tablets + Leuprorelin acetate placebo injection
    Other Name: relugolix
  • Drug: Leuprorelin acetate
    TAK-385 placebo tablets + Leuprorelin acetate 1.88 mg / 3.75 mg injection
Study Arms  ICMJE
  • Experimental: TAK-385
    TAK-385 40 mg administered orally once daily before breakfast + Leuprorelin placebo administered subcutaneously once every 4 weeks
    Intervention: Drug: TAK-385
  • Active Comparator: Leuprorelin acetate
    TAK-385 placebo administered orally once daily before breakfast + Leuprorelin acetate 1.88 mg / 3.75 mg administered subcutaneously once every 4 weeks
    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 Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: April 26, 2019)
320
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 31, 2021
Estimated Primary Completion Date March 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. The participant is a premenopausal Japanese woman aged 20 years or older at the time consent is obtained.
  2. The participant with endometriosis that falls under one of the following. However, in case of recurrence after surgery, it must be diagnosed again by either of the following.

    • The participant who has been diagnosed with endometriosis by Laparotomy or Laparoscopy.
    • The participant who has been confirmed ovarian chocolate cyst by Magnetic Resonance Imaging (MRI) or ultrasonic examination (vaginal, transabdominal or rectal).
    • The participant who has been diagnosed with clinical endometriosis and has the symptom of either induration of Douglas cavum, restriction of uterine mobility or pelvic tenderness confirmed by internal or rectal examination.
  3. The participant must have dysmenorrhea or pelvic pain associated with endometriosis, of which either 1 or both should be at least "moderate" as determined by the investigator or subinvestigator using the B&B scale.
  4. The participant must have maximum VAS score > 30 for pelvic pain associated with endometriosis.
  5. The participant has experienced regular menstrual cycles (25 to 38 days) that should include menstrual bleeding of at least 3 consecutive days (at least 3 regular menstrual cycles to be confirmed).
  6. The participant agrees to use routinely adequate contraception from signing of informed consent throughout the duration of the study.

Exclusion Criteria:

  1. The participant has the following drug usage:

    • Use of the following drugs within 24 weeks:bisphosphonate preparation or other investigational agent
    • Use of the following drugs within 16 weeks (for 1-, 3- and 6-month sustained-release preparations, within 20, 28 and 40 weeks, respectively): gonadotropin-releasing hormone (GnRH) analogues, danazol, or aromatase inhibitors.
    • Use of the following drugs within 8 weeks:dienogest, oral contraceptive or sex hormone preparations (norethindrone, norethisterone, medroxyprogesterone, estrogen, or other progestins, etc.)
    • Use of the following drugs (excluding drugs for external use and supplements) within 4 weeks :anti-coagulant drugs, anti-platelet drugs, tranexamic acid, selective estrogen receptor modulators, activated vitamin D preparations, other vitamin D preparations, calcitonin, ipriflavone, steroid hormones, vitamin K preparations, teriparatide, or denosumab
  2. The participant has received TAK-385 (including placebo) in a previous clinical study.
  3. The participant has ovarian chocolate cyst of 10 cm or more and over 40 years old at the time imaging test is performed.
  4. The participant has a history of panhysterectomy or bilateral oophorectomy.
  5. The participant has had markedly abnormal uterine bleeding or anovulatory bleeding, as determined by the investigator or subinvestigator.
  6. The participant has nondiagnosable abnormal genital bleeding.
  7. The participant has a current history of thyroid gland disorder with irregular menstruation, or has a potential for irregular menstruation due to thyroid gland disorder, as determined by the investigator or subinvestigator.
  8. The participant has uterine fibroid requiring treatment.
  9. The participant has lower abdominal pain due to irritable bowel syndrome or severe interstitial cystitis.
  10. The participant has a previous or current history of pelvic inflammatory disease within 8 weeks.
  11. The participant has a previous or current history of osteoporosis, osteopenia, or other metabolic bone diseases.
  12. The participant has a positive cervical cytology result [other than Negative for Intraepithelial Lesion or Malignancy (NILM) in accordance with the 2014 Bethesda system]. However, the following participant may participate in this study; Atypical Squamous Cells of Undetermined Significance (ASC-US) and negative by high-risk Human Papillomavirus (HPV) test. And furthermore, regarding the participant with negative cervical cytology result conducted within 1 year, she may participate in this study without additional test.
  13. The participant has a malignant tumor or a history of a malignant tumor within 5 years.
  14. The participant has clinically significant cardiovascular disease or uncontrollable hypertension.
  15. The participant is inappropriate for participation in this study based on 12-lead ECG findings, as determined by the investigator or subinvestigator.
  16. The participant has active liver disease or jaundice, or has Alanine aminotransferase (ALT), Aspartate aminotransferase (AST) or total bilirubin > 1.5 times the upper limit of normal in the clinical laboratory tests.
  17. The participant has previous or current history of diseases considered to be inappropriate for participation in this study, including severe hepatic impairment, jaundice, renal impairment, cardiovascular disease, endocrine system disease, metabolic disorder, pulmonary disease, gastrointestinal disease, neural disease, urological disease, immune disease, or mental disorder (especially depression-like symptoms) or suicide attempt resulting from a mental disorder.
  18. The participant has a previous or current history of hypersensitivity to GnRH analogues, or has a previous or current history of severe hypersensitivity to other drugs.
  19. The participant is pregnant, lactating, or intending to become pregnant or to donate ova between the signing date of informed consent and 1 month after the end of the study.
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 NCT03931915
Other Study ID Numbers  ICMJE TAK-385/3-A
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party ASKA Pharmaceutical Co., Ltd.
Study Sponsor  ICMJE ASKA Pharmaceutical Co., Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account ASKA Pharmaceutical Co., Ltd.
Verification Date July 2020

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