A Long-term Extension Study of TAK-385 in the Treatment of Endometriosis

NCT01452685 | Completed Phase 2

• 3 other identifiers: TAK-385/OCT-101U1111-1123-6973JapicCTI-11589
• Study Type: interventional
• Target: 397
• Locations: 1 country
• Sites: 69

Brief Summary

The purpose of this study is to compare the long term safety and efficacy of TAK-385, once daily (QD) following continued administration in participants who completed a Phase II dose-finding study.

Conditions

Endometriosis

Keywords

Drug Therapy

Outcome Measures

Primary Outcomes (8)

• Bone Mineral Density

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

  Up to Week 24.

• Treatment-emergent Adverse Events

  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)

  Up to Week 16

• Vital Signs

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

  Up to Week 24

• Body Weight

  Up to Week 24

• Electrocardiograms

  Up to Week 24.

• Laboratory Values

  Up to Week 24

• Serum NTx

  NTx is one of the biochemical bone metabolism markers

  Up to Week 24

• Serum BAP

  BAP is one of the biochemical bone metabolism markers

  Up to Week 24

Secondary Outcomes (2)

• Visual Analogue Scale (VAS) Score for Pelvic Pain

  Up to Week 24

• VAS Score for Dyspareunia

  Up to Week 24

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 3.75 mg 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:

• \. Participants who have completed TAK-385/CCT-101 study

You may not qualify if:

• Participants who had an adverse event in TAK-385/CCT-101 study which makes continued administration of the study drug difficult
• Participants who became unable to comply with the protocol due to onset of a new disease, symptom, finding, or aggravation of clinical laboratory findings
• Participants in whom investigator deems that the study drug shows no efficacy based on the level of pain, menstruation status, and the status of analgesic drug intake in TAK-385/CCT-101 study, or that study continuation represents an unacceptable risk
• Participants in whom investigator deems that study continuation is difficult due to the occurrence of low estrogen symptoms in TAK-385/CCT-101 study which were attributed to the pharmacological effects of the study drug taking into account the level and frequency of the adverse events etc. as well as the risk-benefit of participants.

Sponsors & Collaborators

• Takeda: lead

Study Sites (69)

Unknown Facility

Nagoya, Aichi-ken, Japan

Location

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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 (GnRH) receptor antagonist, in women with endometriosis-associated pain: phase 2 safety and efficacy 24-week results. BMC Womens Health. 2021 Jun 21;21(1):250. doi: 10.1186/s12905-021-01393-3.

  PMID: 34154590 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

• VP Clinical Science Strategy

  Takeda

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2011
• First Posted: October 17, 2011
• Study Start: March 1, 2012
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: May 8, 2014

Record last verified: 2014-05

Locations

JP (69)