A Placebo-Controlled, Phase 3 Study of Relugolix (TAK-385) 40 mg in the Treatment of Pain Symptoms Associated With Uterine Fibroids

NCT02655224 | Completed Phase 3 Results

• 3 other identifiers: TAK-385-3008U1111-1178-1086JapicCTI-163127
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 11

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of Relugolix (TAK-385) in patients having pain symptoms associated with uterine fibroids.

Conditions

Uterine Fibroids

Keywords

Drug Therapy

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With a Maximum NRS Score of 1 or Less During the 28 Days Before the Final Dose of Study Drug

  Pain symptoms were evaluated using the NRS score. NRS score is a self-reported instrument assessing pain from 0 to 10. Higher scores reflect greater level of pain. The percentage of participants with a score of 1 or less is reported.

  For 28 days before the final dose of study drug (up to Week 12)

Secondary Outcomes (12)

• Percentage of Participants With a Maximum NRS Score of 0 During the 28 Days Before the Final Dose of Study Drug

  For 28 days before the final dose of study drug (up to Week 12)

• Mean NRS Score During the 28 Days Before the Final Dose of Study Drug

  For 28 days before the final dose of study drug (up to Week 12)

• Percentage of Days Without Pain Symptoms (NRS = 0) During the 28 Days Before the Final Dose of Study Drug

  For 28 days before the final dose of study drug (up to Week 12)

• Percentage of Participants With Maximum NRS Score of 1 or Less From Day 1 to 28, From Day 29 to 56, and From Day 57 to 84

  Day 1 to 28, Day 29 to 56, and Day 57 to 84

• Percentage of Participants With a Maximum NRS Score of 0 From Day 1 to 28, From Day 29 to 56, and From Day 57 to 84

  Day 1 to 28, Day 29 to 56, and Day 57 to 84

Study Arms (2)

Relugolix 40 mg

EXPERIMENTAL

Relugolix placebo-matching tablet, orally, once daily before breakfast for 3 to 6 weeks in the run-in period, followed by relugolix 40 mg, tablet, orally once daily before breakfast for 12 weeks.

Drug: Relugolix

Placebo

PLACEBO COMPARATOR

Relugolix placebo-matching tablet, orally, once daily before breakfast for 3 to 6 weeks in the run-in period, followed by relugolix placebo-matching tablet, orally once daily before breakfast for 12 weeks.

Drug: Relugolix placebo

Interventions

Relugolix DRUG

Relugolix Tablets

Also known as: TAK-385

Relugolix 40 mg

Relugolix placebo DRUG

Relugolix placebo-matching tablets

Placebo

Eligibility Criteria

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

You may qualify if:

• In the opinion of the investigator or subinvestigator, the participant is capable of understanding and complying with protocol requirements.
• The participant signs and dates a written, informed consent form prior to the initiation of any study procedures.
• Prior to VISIT 1, the participant has a diagnosis of uterine fibroids confirmed by transvaginal ultrasound, abdominal ultrasound, magnetic resonance imaging (MRI), computed tomography (CT), or laparoscopy, and has never received any surgical treatment for the myoma (measurable noncalcified myoma with a longest diameter of ≥3 cm).
• The participant is a premenopausal Japanese woman.
• The participant is aged 20 years or older on the day of signing and dating the informed consent form.
• The participant has 1 or more measurable noncalcified myomas with a longest diameter of ≥3 cm confirmed by transvaginal ultrasound.
• The participant has experienced 1 or more regular menstrual cycles (25 to 38 days) immediately prior to VISIT 1 and that should include menstrual bleeding for at least 3 consecutive days.
• The participant who is sexually active with a nonsterilized male partner agrees to use routinely adequate contraception from signing of informed consent throughout the study.
• The participant has a maximum Numerical Rating Scale (NRS) score of ≥4 during 1 menstrual cycle just before VISIT 3.
• The participant has pain symptoms associated with uterine fibroids for at least 2 days during 1 menstrual cycle just before VISIT 3.

You may not qualify if:

• The participant has received any investigational compound within 24 weeks prior to the start of the administration of the study drug for the day of first menstruation after VISIT 1.
• The participant has received relugolix (including placebo) in a previous clinical study.
• The participant is an immediate family member or study site employee, or is in a dependent relationship with a study site employee who is involved in conduct of this study (eg, spouse, parent, child, or sibling) or may consent under duress.
• The participant has lower abdominal pain due to irritable bowel syndrome or severe interstitial cystitis.
• The participant has a current history of thyroid gland disorder with irregular menstruation, or has a potential for irregular menstruation due to thyroid gland disorder, as determined by the investigator or subinvestigator.
• The participant has a previous or current history of pelvic inflammatory disease within 8 weeks prior to VISIT 1.
• The participant has a positive Pap smear test result obtained within 1 year prior to VISIT 1 (if there are no previous test results, those who were judged positive in the test conducted before VISIT 2).
• The participant has a history of panhysterectomy or bilateral oophorectomy.
• The participant has had markedly abnormal uterine bleeding or anovulatory bleeding, as determined by the investigator or subinvestigator.
• The participant has a malignant tumor or a history of a malignant tumor within 5 years prior to VISIT 1.
• The participant has been treated with selective estrogen receptor modulators (SERMs) (excluding drugs for external use and dietary supplements) within 4 weeks prior to VISIT 2.
• The participant has been treated with any of the following drugs within 8 weeks prior to VISIT 2: oral contraceptive or sex hormone preparations (norethindrone, norethisterone, medroxyprogesterone, estrogen, or other progestins), and within 16 weeks prior to VISIT 2: gonadotropin-releasing hormone (GnRH) analogues, dienogest, danazol, or aromatase inhibitors (for 1- and 3-month sustained-release preparations, within 20 and 28 weeks prior to VISIT 2, respectively).
• The participant has a previous or current history of severe hypersensitivity or severe allergies to drugs.
• The participant has nondiagnosable abnormal genital bleeding.
• Female participant who is pregnant, lactating, or intending to become pregnant or to donate ova prior to the signing of informed consent, during the study period, or within 1 month after the end of the study.

Sponsors & Collaborators

• Takeda: lead

Study Sites (11)

Unknown Facility

Matsudo, Chiba, Japan

Location

Unknown Facility

Ebetsu, Hokkaido, Japan

Location

Unknown Facility

Sapporo, Hokkaido, Japan

Location

Unknown Facility

Nishinomiya, Hyōgo, Japan

Location

Unknown Facility

Ibaraki, Osaka, Japan

Location

Unknown Facility

Sakai, Osaka, Japan

Location

Unknown Facility

Bunkyo-ku, Tokyo, Japan

Location

Unknown Facility

Minato-ku, Tokyo, Japan

Location

Unknown Facility

Setagaya-ku, Tokyo, Japan

Location

Unknown Facility

Kagoshima, Japan

Location

Unknown Facility

Osaka, Japan

Location

Related Publications (1)

• Osuga Y, Enya K, Kudou K, Hoshiai H. Relugolix, a novel oral gonadotropin-releasing hormone antagonist, in the treatment of pain symptoms associated with uterine fibroids: a randomized, placebo-controlled, phase 3 study in Japanese women. Fertil Steril. 2019 Nov;112(5):922-929.e2. doi: 10.1016/j.fertnstert.2019.07.013. Epub 2019 Oct 6.

  PMID: 31594635 DERIVED

MeSH Terms

Conditions

Leiomyoma

Interventions

relugolix

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Medical Director
• Organization: Takeda

trialdisclosures@takeda.com

+1-877-825-3327

Study Officials

• Study Director

  Takeda

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• 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: January 12, 2016
• First Posted: January 13, 2016
• Study Start: March 26, 2016
• Primary Completion: May 16, 2017
• Study Completion: May 19, 2017
• Last Updated: March 22, 2019
• Results First Posted: March 22, 2019

Record last verified: 2018-12

Locations

JP (11)