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

NCT03931915 | Completed Phase 3

• 1 other identifier: TAK-385/3-A
• Study Type: interventional
• Target: 335
• Locations: 1 country
• Sites: 41

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.

Conditions

Endometriosis

Outcome Measures

Primary Outcomes (1)

• Change of maximum Visual Analogue Scale (VAS) score for endometriosis associated pelvic pain

  Pelvic pain will be assessed using the VAS (0 - 100) as pain evaluation scale

  Baseline and the last 28 days of treatment period

Secondary Outcomes (14)

• Change of mean VAS score for endometriosis associated pelvic pain

  Baseline and the last 28 days of treatment period

• VAS score for endometriosis associated pelvic pain

  Up to Week 24

• Change of VAS score for endometriosis associated pelvic pain

  Baseline and up to Week 24

• VAS score for menstrual pain

  Up to Week 24

• Change of VAS score for menstrual pain

  Baseline and up to Week 24

Study Arms (2)

TAK-385

EXPERIMENTAL

TAK-385 40 mg administered orally once daily before breakfast + Leuprorelin placebo administered subcutaneously once every 4 weeks

Drug: TAK-385

Leuprorelin acetate

ACTIVE COMPARATOR

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

Interventions

TAK-385 DRUG

TAK-385 40 mg tablets + Leuprorelin acetate placebo injection

Also known as: relugolix

TAK-385

Leuprorelin acetate DRUG

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

Leuprorelin acetate

Eligibility Criteria

• Age: 20 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The participant is a premenopausal Japanese woman aged 20 years or older at the time consent is obtained.
• 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.
• 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.
• The participant must have maximum VAS score \> 30 for pelvic pain associated with endometriosis.
• 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).
• The participant agrees to use routinely adequate contraception from signing of informed consent throughout the duration of the study.

You may not qualify if:

• 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
• The participant has received TAK-385 (including placebo) in a previous clinical study.
• The participant has ovarian chocolate cyst of 10 cm or more and over 40 years old at the time imaging test is performed.
• The participant has a history of panhysterectomy or bilateral oophorectomy.
• The participant has had markedly abnormal uterine bleeding or anovulatory bleeding, as determined by the investigator or subinvestigator.
• The participant has nondiagnosable abnormal genital bleeding.
• 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.
• The participant has uterine fibroid requiring treatment.
• The participant has lower abdominal pain due to irritable bowel syndrome or severe interstitial cystitis.
• The participant has a previous or current history of pelvic inflammatory disease within 8 weeks.
• The participant has a previous or current history of osteoporosis, osteopenia, or other metabolic bone diseases.

Sponsors & Collaborators

• ASKA Pharmaceutical Co., Ltd.: lead

Study Sites (41)

Chubu Rosai Hospital

Aichi, Japan

Location

Meitetsu Hospital

Aichi, Japan

Location

Aiiku Ladies Clinic

Chiba, Japan

Location

Chiba Aoba Municipal Hospital

Chiba, Japan

Location

Tokyo Bay Urayasu Ichikawa Medical Center

Chiba, Japan

Location

Tsujinaka Hospital Kashiwanoha

Chiba, Japan

Location

Fujito Clinic

Hiroshima, Japan

Location

Hashimoto Clinic

Hokkaido, Japan

Location

Tokeidai Memorial Hospital

Hokkaido, Japan

Location

Yoshio Obstetrics Gynecology Hospital

Hokkaido, Japan

Location

Shinsuma Hospital

Hyōgo, Japan

Location

Kagawa Prefectural Central Hospital

Kagawa, Japan

Location

Takamatsu Red Cross Hospital

Kagawa, Japan

Location

Fujisawa City Hospital

Kanagawa, Japan

Location

Rinkan Clinic

Kanagawa, Japan

Location

Second Kawasaki Saiwai Clinic

Kanagawa, Japan

Location

Tawada Ladies Clinic

Kanagawa, Japan

Location

Japanese Red Cross Kumamoto Hospital

Kumamoto, Japan

Location

Kurashiki Medical Clinic

Okayama, Japan

Location

Chayamachi Ladies Clinic

Osaka, Japan

Location

Hayakawa Clinic

Osaka, Japan

Location

Minami-Morimachi Ladies Clinic

Osaka, Japan

Location

Nomura Clinic Nanba

Osaka, Japan

Location

Rikako Ladies Clinic

Osaka, Japan

Location

Tanabe Ladies Clinic

Osaka, Japan

Location

Yoshimura Ladies Clinic

Osaka, Japan

Location

Dantsuka Clinic

Saitama, Japan

Location

Kashiwazaki Ladies Clinic

Saitama, Japan

Location

Maruyama Memorial General Hospital

Saitama, Japan

Location

Kusatsu General Hospital

Shiga, Japan

Location

Akasaka-Mitsuke Miyazaki Clinic

Tokyo, Japan

Location

Ginza Yoshida Hospital

Tokyo, Japan

Location

Hamada Hospital

Tokyo, Japan

Location

Ikebukuro Metroporitan Clinic

Tokyo, Japan

Location

NS Clinic

Tokyo, Japan

Location

Sei Women's Clinic

Tokyo, Japan

Location

Seijo Kinoshita Hospital

Tokyo, Japan

Location

Shimamura Memorial Hospital

Tokyo, Japan

Location

Toranomon Women's Clinic

Tokyo, Japan

Location

Yokokura Clinic

Tokyo, Japan

Location

Yukawa Women's Clinic

Tokyo, Japan

Location

Related Publications (1)

• Harada T, Osuga Y, Suzuki Y, Fujisawa M, Fukui M, Kitawaki J. Relugolix, an oral gonadotropin-releasing hormone receptor antagonist, reduces endometriosis-associated pain compared with leuprorelin in Japanese women: a phase 3, randomized, double-blind, noninferiority study. Fertil Steril. 2022 Mar;117(3):583-592. doi: 10.1016/j.fertnstert.2021.11.013. Epub 2021 Dec 8.

  PMID: 34895700 DERIVED

MeSH Terms

Conditions

Endometriosis

Interventions

relugolix; Leuprolide

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Gonadotropin-Releasing Hormone; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2019
• First Posted: April 30, 2019
• Study Start: May 8, 2019
• Primary Completion: June 12, 2020
• Study Completion: September 28, 2020
• Last Updated: December 11, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

JP (41)