Efficacy and Safety of TAK-385 in the Treatment of Uterine Fibroids

NCT ID: NCT01452659

Last Updated: 2013-01-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 216 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-10-31
• Study Completion Date: 2012-09-30

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 uterine fibroids.

Detailed Description

This study is a Phase II, multicenter, randomized, double-blind, parallel-group, placebo-controlled for evaluation of the efficacy and safety of TAK-385 10, 20, and 40 mg (p.o.) following once daily administration for 12 weeks in women with uterine fibroids.

Conditions

Uterine Fibroids

Study Design

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

Study Groups

TAK-385 10 mg QD

Group Type: EXPERIMENTAL

TAK-385

Intervention Type: DRUG

TAK-385 10 mg, tablets, orally, once daily 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 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 for up to 12 weeks.

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

TAK-385 placebo-matching tablets, orally, once daily for up to 12 weeks.

Interventions

TAK-385

TAK-385 10 mg, tablets, orally, once daily for up to 12 weeks.

Intervention Type: DRUG

TAK-385

TAK-385 20 mg, tablets, orally, once daily for up to 12 weeks.

Intervention Type: DRUG

TAK-385

TAK-385 40 mg, tablets, orally, once daily for up to 12 weeks.

Intervention Type: DRUG

Placebo

TAK-385 placebo-matching tablets, orally, once daily for up to 12 weeks.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. The participant has been diagnosed with uterine fibroids and has never received surgical treatment for the myoma.

2. The participant is a premenopausal woman.

3. The participant has one or more measurable noncalcified myomas confirmed by transvaginal sonography.

4. The participant has experienced regular menstrual cycles

5. The participant is diagnosed as menorrhagia

Exclusion Criteria

1. Participants with a screening Hb <8 g/dL

2. Participants with a previous or current history of blood disorders

3. Participants with a known history of severe hypersensitivity or severe allergy to sanitary goods

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

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

6. Participants with a previous or current history of pelvic inflammatory disease

7. Participants with a positive PAP smear test result

8. Participants with a history of panhysterectomy or bilateral oophorectomy

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

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

11. 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

12. 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

13. Participants who have been treated with a bisphosphonate preparation

14. Participants with a previous or current history of severe hypersensitivity or severe allergy to drugs

15. Participants with non-diagnosable abnormal genital bleeding

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

17. Participants with clinically significant cardiovascular disease or uncontrollable hypertension

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

19. 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)

• 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

Chiba, Chiba, Japan

Itchihara-shi, Chiba, Japan

Matsuno-shi, Chiba, Japan

Matsuyama, Ehime, Japan

Nihama-shi, Ehime, Japan

Fukui-shi, Fukui, Japan

Fukuoka, Fukuoka, Japan

Iizuka-shi, Fukuoka, Japan

Yanagigawa-shi, Fukuoka, Japan

Mebashi-shi, Gunma, Japan

Ebetsu-shi, Hokkaido, Japan

Sapporo, Hokkaido, Japan

Amagasaki-shi, Hyōgo, Japan

Kobe, Hyōgo, Japan

Kamakura-shi, Kanagawa, Japan

Yokohama, Kanagawa, Japan

Ōita, Oita Prefecture, Japan

Ibaraki-shi, Osaka, Japan

Osaka, Osaka, Japan

Sakai-shi, Osaka, Japan

Tondabayashi-shi, Osaka, Japan

Chuo-ku, Tokyo, Japan

Itabashi-ku, Tokyo, Japan

Setagaya-ku, Tokyo, Japan

Shinagawa-ku, Tokyo, Japan

Suginami-ku, Tokyo, Japan

Toyama, Toyama, Japan

Countries

Japan

References

Hoshiai H, Seki Y, Kusumoto T, Kudou K, Tanimoto M. Relugolix for oral treatment of uterine leiomyomas: a dose-finding, randomized, controlled trial. BMC Womens Health. 2021 Oct 28;21(1):375. doi: 10.1186/s12905-021-01475-2.

Reference Type: DERIVED

PMID: 34711224 (View on PubMed)

Other Identifiers

U1111-1123-6815

Identifier Type: REGISTRY

Identifier Source: secondary_id

JapicCTI-111590

Identifier Type: REGISTRY

Identifier Source: secondary_id

TAK-385/CCT-001

Identifier Type: -

Identifier Source: org_study_id