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

NCT01458301 | Completed Phase 2

• 3 other identifiers: TAK-385/CCT-101U1111-1123-6890JapicCTI-111588
• Study Type: interventional
• Target: 487
• Locations: 1 country
• Sites: 69

Brief Summary

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.

Conditions

Endometriosis

Keywords

Drug Therapy

Outcome Measures

Primary Outcomes (1)

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

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

  Week 12 (one menstrual cycle)

Secondary Outcomes (10)

• VAS Score for Pelvic Pain

  Up to Week 12.

• VAS Score for Dyspareunia

  Up to Week 12.

• Bone Mineral Density

  Up to Week 12.

• Treatment-emergent Adverse Events.

  Up to Week 16

• Vital Signs

  Up to Week 12.

Study Arms (5)

Placebo

PLACEBO COMPARATOR

Drug: Placebo

TAK-385 10 mg QD

EXPERIMENTAL

Drug: TAK-385

TAK-385 20 mg QD

EXPERIMENTAL

Drug: TAK-385

TAK-385 40 mg QD

EXPERIMENTAL

Drug: TAK-385

Leuplin

OTHER

Drug: Leuprorelin acetate

Interventions

Placebo DRUG

TAK-385 placebo-matching tablets, orally, once daily and Leuprorelin acetate placebo injection, subcutaneously, once every 4 weeks for up to 12 weeks.

Placebo

TAK-385 DRUG

TAK-385 10 mg, tablets, orally, once daily and Leuprorelin acetate placebo injection, subcutaneously, once every 4 weeks for up to 12 weeks

TAK-385 10 mg QD

Leuprorelin acetate DRUG

TAK-385 placebo-matching tablets, orally, once daily and Leuprorelin acetate injection, subcutaneously, once every 4 weeks for up to 12 weeks

Also known as: Leuplin

Leuplin

Eligibility Criteria

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

You may qualify if:

• Premenopausal women
• The participants must have dysmenorrhea and pelvic pain associated with endometriosis.
• The participant has experienced a regular menstrual cycle.
• The participant has been diagnosed with endometriosis by method a), b), or c).
• Laparotomy
• Laparoscopy
• Chocolate cyst of the ovary confirmed by MRI

You may not qualify if:

• Participants diagnosed with measurable uterine fibroids with the longest diameter of 3 cm or larger
• Participants with lower abdominal pain due to irritable bowel syndrome or severe interstitial cystitis
• Participants with a previous or current history of thyroid dysfunction
• Participants with current or previous history of pelvic inflammatory disease
• Participants with positive PAP smear test result conducted
• Participants with a history of panhysterectomy or bilateral oophorectomy
• Participants judged by investigator to have marked abnormal uterine bleeding or anovulatory bleeding
• Participants with a previous or current history of a malignant tumor
• 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
• 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
• Participants who have been treated with bisphosphonate preparation
• 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
• Participants with non-diagnosable abnormal genital bleeding
• Participants with a previous or current history of osteoporosis, bone mass loss, or other metabolic bone diseases
• Participants with clinically significant cardiovascular disease or uncontrollable hypertension

Sponsors & Collaborators

• Takeda: lead

Study Sites (69)

Unknown Facility

Nagoya, Aichi-ken, Japan

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Chiba, Chiba, Japan

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Funabashi-shi, Chiba, Japan

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Ichihara-shi, Chiba, Japan

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Yachiyo-shi, Chiba, Japan

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Nihama-shi, Ehime, Japan

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Fukui-shi, Fukui, Japan

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Fukuoka, Fukuoka, Japan

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Iizuka-shi, Fukuoka, Japan

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Kitakyushu-shi, Fukuoka, Japan

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Onga-gun, Fukuoka, Japan

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Yanagawa-shi, Fukuoka, Japan

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Koriyama-shi, Fukushima, Japan

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Takayama-shi, Gifu, Japan

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Takasaki-shi, Gunma, Japan

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Hirosima-shi, Hiroshima, Japan

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Ebetsu-shi, Hokkaido, Japan

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Ishikari-shi, Hokkaido, Japan

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Sapporo, Hokkaido, Japan

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Amagasaki-shi, Hyōgo, Japan

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Kako-gun, Hyōgo, Japan

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Kawanishi-shi, Hyōgo, Japan

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Kobe, Hyōgo, Japan

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Kanazawa, Ishikawa-ken, Japan

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Marugame-shi, Kagawa-ken, Japan

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Kagoshima, Kagoshima-ken, Japan

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Hiratsuka-shi, Kanagawa, Japan

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Kamakura-shi, Kanagawa, Japan

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Kawasaki-shi, Kanagawa, Japan

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Yamato-shi, Kanagawa, Japan

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Yokohama, Kanagawa, Japan

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Nankoku-shi, Kochi, Japan

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Kumamoto, Kumamoto, Japan

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Kyoto, Kyoto, Japan

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Sendai, Miyagi, Japan

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Matsumoto-shi, Nagano, Japan

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Nagano, Nagano, Japan

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Suzaka-shi, Nagano, Japan

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Nara, Nara, Japan

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Ōita, Oita Prefecture, Japan

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Kurashiki-shi, Okayama-ken, Japan

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Okayama, Okayama-ken, Japan

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Hirakata-shi, Osaka, Japan

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Ibaraki-shi, Osaka, Japan

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Ikeda-shi, Osaka, Japan

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Osaka, Osaka, Japan

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Sakai-shi, Osaka, Japan

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Suita-shi, Osaka, Japan

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Tondabayashi-shi, Osaka, Japan

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Toyonaka-shi, Osaka, Japan

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Iruma-shi, Saitama, Japan

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Kusatsu-shi, Shiga, Japan

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Hamamatsu, Shizuoka, Japan

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Numazu-shi, Shizuoka, Japan

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Yaizu-shi, Shizuoka, Japan

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Komatsushima-shi, Tokushima, Japan

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Naruto-shi, Tokushima, Japan

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Bunkyo-ku, Tokyo, Japan

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Chiyoda-ku, Tokyo, Japan

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Chuo-ku, Tokyo, Japan

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Itabashi-ku, Tokyo, Japan

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Machida-shi, Tokyo, Japan

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Minato-ku, Tokyo, Japan

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Ohta-ku, Tokyo, Japan

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Setagaya-ku, Tokyo, Japan

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Shinagawa-ku, Tokyo, Japan

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Suginami-ku, Tokyo, Japan

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Toyama, Toyama, Japan

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Yamaguchi, Yamaguchi, Japan

Location

Related Publications (1)

• Osuga Y, Seki Y, Tanimoto M, Kusumoto T, Kudou K, Terakawa N. Relugolix, an oral gonadotropin-releasing hormone receptor antagonist, reduces endometriosis-associated pain in a dose-response manner: a randomized, double-blind, placebo-controlled study. Fertil Steril. 2021 Feb;115(2):397-405. doi: 10.1016/j.fertnstert.2020.07.055. Epub 2020 Sep 7.

  PMID: 32912633 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 Officials

• Senior Director

  Takeda

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• 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: August 31, 2011
• First Posted: October 24, 2011
• Study Start: October 1, 2011
• Primary Completion: August 1, 2013
• Study Completion: August 1, 2013
• Last Updated: February 25, 2014

Record last verified: 2014-02

Locations

JP (69)