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

NCT01452659 | Completed Phase 2

• 3 other identifiers: TAK-385/CCT-001U1111-1123-6815JapicCTI-111590
• Study Type: interventional
• Target: 216
• Locations: 1 country
• Sites: 27

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.

Conditions

Uterine Fibroids

Keywords

Drug Therapy

Outcome Measures

Primary Outcomes (1)

• Decrease in menstrual blood loss

  Blood loss will be assessed using the Pictorial Blood Loss Assessment Chart (PBAC).

  Week 12 (one menstrual cycle)

Secondary Outcomes (20)

• Decrease in menstrual blood loss

  Up to Week 6

• Decrease in menstrual blood loss

  Up to Week 12.

• Amenorrhea

  Week 12 (one menstrual cycle).

• Amenorrhea

  Up to Week 6.

• Amenorrhea

  Up to Week 12.

Study Arms (4)

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

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

TAK-385 DRUG

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

TAK-385 10 mg QD

Placebo DRUG

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

Placebo

Eligibility Criteria

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

You may qualify if:

• The participant has been diagnosed with uterine fibroids and has never received surgical treatment for the myoma.
• The participant is a premenopausal woman.
• The participant has one or more measurable noncalcified myomas confirmed by transvaginal sonography.
• The participant has experienced regular menstrual cycles
• The participant is diagnosed as menorrhagia

You may not qualify if:

• Participants with a screening Hb \<8 g/dL
• Participants with a previous or current history of blood disorders
• Participants with a known history of severe hypersensitivity or severe allergy to sanitary goods
• 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 a previous or current history of pelvic inflammatory disease
• Participants with a positive PAP smear test result
• 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 a bisphosphonate preparation
• Participants with a previous or current history of severe hypersensitivity or severe allergy to drugs
• Participants with non-diagnosable abnormal genital bleeding

Sponsors & Collaborators

• Takeda: lead

Study Sites (27)

Unknown Facility

Chiba, Chiba, Japan

Location

Unknown Facility

Itchihara-shi, Chiba, Japan

Location

Unknown Facility

Matsuno-shi, Chiba, Japan

Location

Unknown Facility

Matsuyama, Ehime, Japan

Location

Unknown Facility

Nihama-shi, Ehime, Japan

Location

Unknown Facility

Fukui-shi, Fukui, Japan

Location

Unknown Facility

Fukuoka, Fukuoka, Japan

Location

Unknown Facility

Iizuka-shi, Fukuoka, Japan

Location

Unknown Facility

Yanagigawa-shi, Fukuoka, Japan

Location

Unknown Facility

Mebashi-shi, Gunma, Japan

Location

Unknown Facility

Ebetsu-shi, Hokkaido, Japan

Location

Unknown Facility

Sapporo, Hokkaido, Japan

Location

Unknown Facility

Amagasaki-shi, Hyōgo, Japan

Location

Unknown Facility

Kobe, Hyōgo, Japan

Location

Unknown Facility

Kamakura-shi, Kanagawa, Japan

Location

Unknown Facility

Yokohama, Kanagawa, Japan

Location

Unknown Facility

Ōita, Oita Prefecture, Japan

Location

Unknown Facility

Ibaraki-shi, Osaka, Japan

Location

Unknown Facility

Osaka, Osaka, Japan

Location

Unknown Facility

Sakai-shi, Osaka, Japan

Location

Unknown Facility

Tondabayashi-shi, Osaka, Japan

Location

Unknown Facility

Chuo-ku, Tokyo, Japan

Location

Unknown Facility

Itabashi-ku, Tokyo, Japan

Location

Unknown Facility

Setagaya-ku, Tokyo, Japan

Location

Unknown Facility

Shinagawa-ku, Tokyo, Japan

Location

Unknown Facility

Suginami-ku, Tokyo, Japan

Location

Unknown Facility

Toyama, Toyama, Japan

Location

Related Publications (1)

• 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.

  PMID: 34711224 DERIVED

MeSH Terms

Conditions

Leiomyoma

Interventions

relugolix

Condition Hierarchy (Ancestors)

Neoplasms, Muscle Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

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 17, 2011
• Study Start: October 1, 2011
• Primary Completion: September 1, 2012
• Study Completion: September 1, 2012
• Last Updated: January 21, 2013

Record last verified: 2013-01

Locations

JP (27)