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

NCT ID: NCT01458301

Last Updated: 2014-02-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 487 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-10-31
• Study Completion Date: 2013-08-31

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.

Detailed Description

This Phase II, multicenter, double-blind, randomized, parallel-group, placebo-controlled study will evaluate the efficacy and safety of 3 dose levels (10, 20, and 40 mg) of TAK-385 following oral administration for 12 weeks in women with endometriosis.

Conditions

Endometriosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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

TAK-385 10 mg QD

Group Type: EXPERIMENTAL

TAK-385

Intervention Type: 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 20 mg QD

Group Type: EXPERIMENTAL

TAK-385

Intervention Type: DRUG

TAK-385 20 mg, tablets, orally, once daily and Leuprorelin acetate placebo injection, subcutaneously, once every 4 weeks for up to 12 weeks

TAK-385 40 mg QD

Group Type: EXPERIMENTAL

TAK-385

Intervention Type: DRUG

TAK-385 40 mg, tablets, orally, once daily and Leuprorelin acetate placebo injection, subcutaneously, once every 4 weeks for up to 12 weeks

Leuplin

Group Type: OTHER

Leuprorelin acetate

Intervention Type: DRUG

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

Interventions

Placebo

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

Intervention Type: DRUG

TAK-385

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

Intervention Type: DRUG

TAK-385

TAK-385 20 mg, tablets, orally, once daily and Leuprorelin acetate placebo injection, subcutaneously, once every 4 weeks for up to 12 weeks

Intervention Type: DRUG

TAK-385

TAK-385 40 mg, tablets, orally, once daily and Leuprorelin acetate placebo injection, subcutaneously, once every 4 weeks for up to 12 weeks

Intervention Type: DRUG

Leuprorelin acetate

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

Intervention Type: DRUG

Other Intervention Names

Leuplin

Eligibility Criteria

Inclusion Criteria

1. Premenopausal women

2. The participants must have dysmenorrhea and pelvic pain associated with endometriosis.

3. The participant has experienced a regular menstrual cycle.

4. The participant has been diagnosed with endometriosis by method a), b), or c).

• Laparotomy
• Laparoscopy
• Chocolate cyst of the ovary confirmed by MRI

Exclusion Criteria

1. Participants diagnosed with measurable uterine fibroids with the longest diameter of 3 cm or larger

2. Participants with lower abdominal pain due to irritable bowel syndrome or severe interstitial cystitis

3. Participants with a previous or current history of thyroid dysfunction

4. Participants with current or previous history of pelvic inflammatory disease

5. Participants with positive PAP smear test result conducted

6. Participants with a history of panhysterectomy or bilateral oophorectomy

7. Participants judged by investigator to have marked abnormal uterine bleeding or anovulatory bleeding

8. Participants with a previous or current history of a malignant tumor

9. 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

10. 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

11. Participants who have been treated with bisphosphonate preparation

12. 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

13. Participants with non-diagnosable abnormal genital bleeding

14. Participants with a previous or current history of osteoporosis, bone mass loss, or other metabolic bone diseases

15. Participants with clinically significant cardiovascular disease or uncontrollable hypertension

16. Participants judged by investigator to be inappropriate to participate in this study based on the 12-lead electrocardiogram (ECG) findings

17. Participants with active liver disease or jaundice, or with alanine aminotransferase (ALT), aspartate aminotransferase (AST), or total bilirubin > 1.5 times the upper limit of normal (ULN) in the clinical laboratory tests

• Minimum Eligible Age: 20 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Takeda

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Senior Director

Role: STUDY_DIRECTOR

Takeda

Locations

Nagoya, Aichi-ken, Japan

Chiba, Chiba, Japan

Funabashi-shi, Chiba, Japan

Ichihara-shi, Chiba, Japan

Yachiyo-shi, Chiba, Japan

Nihama-shi, Ehime, Japan

Fukui-shi, Fukui, Japan

Fukuoka, Fukuoka, Japan

Iizuka-shi, Fukuoka, Japan

Kitakyushu-shi, Fukuoka, Japan

Onga-gun, Fukuoka, Japan

Yanagawa-shi, Fukuoka, Japan

Koriyama-shi, Fukushima, Japan

Takayama-shi, Gifu, Japan

Takasaki-shi, Gunma, Japan

Hirosima-shi, Hiroshima, Japan

Ebetsu-shi, Hokkaido, Japan

Ishikari-shi, Hokkaido, Japan

Sapporo, Hokkaido, Japan

Amagasaki-shi, Hyōgo, Japan

Kako-gun, Hyōgo, Japan

Kawanishi-shi, Hyōgo, Japan

Kobe, Hyōgo, Japan

Kanazawa, Ishikawa-ken, Japan

Marugame-shi, Kagawa-ken, Japan

Kagoshima, Kagoshima-ken, Japan

Hiratsuka-shi, Kanagawa, Japan

Kamakura-shi, Kanagawa, Japan

Kawasaki-shi, Kanagawa, Japan

Yamato-shi, Kanagawa, Japan

Yokohama, Kanagawa, Japan

Nankoku-shi, Kochi, Japan

Kumamoto, Kumamoto, Japan

Kyoto, Kyoto, Japan

Sendai, Miyagi, Japan

Matsumoto-shi, Nagano, Japan

Nagano, Nagano, Japan

Suzaka-shi, Nagano, Japan

Nara, Nara, Japan

Ōita, Oita Prefecture, Japan

Kurashiki-shi, Okayama-ken, Japan

Okayama, Okayama-ken, Japan

Hirakata-shi, Osaka, Japan

Ibaraki-shi, Osaka, Japan

Ikeda-shi, Osaka, Japan

Osaka, Osaka, Japan

Sakai-shi, Osaka, Japan

Suita-shi, Osaka, Japan

Tondabayashi-shi, Osaka, Japan

Toyonaka-shi, Osaka, Japan

Iruma-shi, Saitama, Japan

Kusatsu-shi, Shiga, Japan

Hamamatsu, Shizuoka, Japan

Numazu-shi, Shizuoka, Japan

Yaizu-shi, Shizuoka, Japan

Komatsushima-shi, Tokushima, Japan

Naruto-shi, Tokushima, Japan

Bunkyo-ku, Tokyo, Japan

Chiyoda-ku, Tokyo, Japan

Chuo-ku, Tokyo, Japan

Itabashi-ku, Tokyo, Japan

Machida-shi, Tokyo, Japan

Minato-ku, Tokyo, Japan

Ohta-ku, Tokyo, Japan

Setagaya-ku, Tokyo, Japan

Shinagawa-ku, Tokyo, Japan

Suginami-ku, Tokyo, Japan

Toyama, Toyama, Japan

Yamaguchi, Yamaguchi, Japan

Countries

Japan

References

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.

Reference Type: DERIVED

PMID: 32912633 (View on PubMed)

Other Identifiers

U1111-1123-6890

Identifier Type: REGISTRY

Identifier Source: secondary_id

JapicCTI-111588

Identifier Type: REGISTRY

Identifier Source: secondary_id

TAK-385/CCT-101

Identifier Type: -

Identifier Source: org_study_id