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

Takeda

Status and phase: Completed; Phase 2

Conditions: Uterine Fibroids

Treatments: Drug: TAK-385; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01452659

U1111-1123-6815 (Registry Identifier)

TAK-385/CCT-001

JapicCTI-111590 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 216 patients

Sex: Female

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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216 participants in 4 patient groups, including a placebo group

TAK-385 10 mg QD

Experimental group

Treatment:

Drug: TAK-385

Drug: TAK-385

Drug: TAK-385

TAK-385 20 mg QD

Experimental group

Treatment:

Drug: TAK-385

Drug: TAK-385

Drug: TAK-385

TAK-385 40 mg QD

Experimental group

Treatment:

Drug: TAK-385

Drug: TAK-385

Drug: TAK-385

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo