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Trial record 7 of 21 for:    relugolix

Clinical Study to Evaluate Efficacy and Safety of TAK-385 40 mg Compared With Leuprorelin in Patients With Endometriosis

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ClinicalTrials.gov Identifier: NCT03931915
Recruitment Status : Recruiting
First Posted : April 30, 2019
Last Update Posted : July 1, 2019
Sponsor:
Information provided by (Responsible Party):
ASKA Pharmaceutical Co., Ltd.

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.

Condition or disease Intervention/treatment Phase
Endometriosis Drug: TAK-385 Drug: Leuprorelin acetate Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 320 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase III Clinical Study to Evaluate Efficacy and Safety of TAK-385 40 mg Compared With Leuprorelin in Patients With Endometriosis
Actual Study Start Date : May 8, 2019
Estimated Primary Completion Date : March 31, 2021
Estimated Study Completion Date : March 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endometriosis

Arm Intervention/treatment
Experimental: TAK-385
TAK-385 40 mg administered orally once daily before breakfast + Leuprorelin placebo administered subcutaneously once every 4 weeks
Drug: TAK-385
TAK-385 40 mg tablets + Leuprorelin acetate placebo injection
Other Name: relugolix

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
Drug: Leuprorelin acetate
TAK-385 placebo tablets + Leuprorelin acetate 1.88 mg / 3.75 mg injection




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. VAS score for dyspareunia [ Time Frame: Up to Week 24 ]
    Dyspareunia will be assessed using the VAS (0 - 100) as pain evaluation scale

  9. 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

  10. Adverse event [ Time Frame: Up to Week 28 ]
  11. Bone mineral density [ Time Frame: Up to Week 24 ]
  12. Serum concentrations of NTx (N-telopeptide) [ Time Frame: Up to Week 24 ]
  13. Serum concentrations of BAP (Bone alkaline phosphatase) [ Time Frame: Up to Week 24 ]
  14. Period from the last dose of study drug to return of menstrual cycles [ Time Frame: From Week 24 to Week 28 ]


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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03931915


Contacts
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Contact: ASKA pharmaceutical Co., Ltd. Clinical Development Dept. +81-3-5484-8333 aska-clinical@aska-pharma.co.jp

Locations
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Japan
Chubu Rosai Hospital Recruiting
Aichi, Japan
Meitetsu Hospital Recruiting
Aichi, Japan
Aiiku Ladies Clinic Recruiting
Chiba, Japan
Chiba Aoba Municipal Hospital Recruiting
Chiba, Japan
Tokyo Bay Urayasu Ichikawa Medical Center Recruiting
Chiba, Japan
Tsujinaka Hospital Kashiwanoha Recruiting
Chiba, Japan
Fujito Clinic Recruiting
Hiroshima, Japan
Hashimoto Clinic Recruiting
Hokkaido, Japan
Tokeidai Memorial Clinic Recruiting
Hokkaido, Japan
Yoshio Obstetrics Gynecology Hospital Recruiting
Hokkaido, Japan
Shinsuma Hospital Recruiting
Hyogo, Japan
Kagawa Prefectural Central Hospital Recruiting
Kagawa, Japan
Takamatsu Red Cross Hospital Recruiting
Kagawa, Japan
Fujisawa City Hospital Recruiting
Kanagawa, Japan
Rinkan Clinic Recruiting
Kanagawa, Japan
Second Kawasaki Saiwai Clinic Recruiting
Kanagawa, Japan
Tawada Ladies Clinic Recruiting
Kanagawa, Japan
Japanese Red Cross Kumamoto Hospital Recruiting
Kumamoto, Japan
Kurashiki Medical Clinic Recruiting
Okayama, Japan
Chayamachi Ladies Clinic Recruiting
Osaka, Japan
Hayakawa Clinic Recruiting
Osaka, Japan
Minami-Morimachi Ladies Clinic Recruiting
Osaka, Japan
Nomura Clinic Nanba Recruiting
Osaka, Japan
Rikako Ladies Clinic Recruiting
Osaka, Japan
Tanabe Ladies Clinic Recruiting
Osaka, Japan
Yoshimura Ladies Clinic Recruiting
Osaka, Japan
Dantsuka Clinic Recruiting
Saitama, Japan
Kashiwazaki Ladies Clinic Recruiting
Saitama, Japan
Maruyama Memorial General Hospital Recruiting
Saitama, Japan
Kusatsu General Hospital Recruiting
Shiga, Japan
Akasaka-Mitsuke Miyazaki Clinic Recruiting
Tokyo, Japan
Ginza Yoshida Hospital Recruiting
Tokyo, Japan
Hamada Hospital Recruiting
Tokyo, Japan
Ikebukuro Metroporitan Clinic Recruiting
Tokyo, Japan
NS Clinic Recruiting
Tokyo, Japan
Sei Women's Clinic Recruiting
Tokyo, Japan
Seijo Kinoshita Hospital Recruiting
Tokyo, Japan
Shimamura Memorial Hospital Recruiting
Tokyo, Japan
Toranomon Women's Clinic Recruiting
Tokyo, Japan
Yokokura Clinic Recruiting
Tokyo, Japan
Yukawa Women's Clinic Recruiting
Tokyo, Japan
Sponsors and Collaborators
ASKA Pharmaceutical Co., Ltd.

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Responsible Party: ASKA Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT03931915     History of Changes
Other Study ID Numbers: TAK-385/3-A
First Posted: April 30, 2019    Key Record Dates
Last Update Posted: July 1, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

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