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

Phase 2

Completed

• Conditions: Uterine Fibroids
• Interventions: Drug: TAK-385; Drug: Placebo

• Registration Number: NCT01452659
• Lead Sponsor: Takeda

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.

Study Timeline

• Study First Submitted: 2011-08-31
• Study Start: 2011-10
• Study First Submitted QC: 2011-10-12
• Study First Posted: 2011-10-17
• Primary Completion: 2012-09
• Study Completion: 2012-09
• Status Verified: 2013-01
• Last Update Submitted: 2013-01-17
• Last Update Posted: 2013-01-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 216

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

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TAK-385 10 mg QD	TAK-385	-
TAK-385 40 mg QD	TAK-385	-
Placebo	Placebo	-
TAK-385 20 mg QD	TAK-385	-

Primary Outcome Measures

Name	Time	Method
Decrease in menstrual blood loss	Week 12 (one menstrual cycle)	Blood loss will be assessed using the Pictorial Blood Loss Assessment Chart (PBAC).

Secondary Outcome Measures

Name	Time	Method
Bone Mineral Density	Up to Week 12.	Measured by Dual-energy X-ray absorptiometry (DXA)
Amenorrhea	Up to Week 12.	Amenorrhea will be assessed using PBAC
Hemoglobin Concentration in Blood	Up to Week 12.
Serum BAP	Up to Week 12	BAP is one of the biochemical bone metabolism markers
Pain Symptom	Up to Week 12.	Measured by Numerical Rating Scale.
Quality of Life (QOL) Score	Up to Week 12.	QOL will be assessed using Uterine Fibroid Symptom and Quality of Life (UFS-QOL)
Vital Signs	Up to Week 12.	Vital signs will include body temperature, sitting blood pressure, and pulse (bpm).
Electrocardiograms		Up to Week 12.
Myoma Volume	Up to Week 12.
Laboratory Values	Up to Week 12
Decrease in menstrual blood loss	Up to Week 12.	Blood loss will be assessed using PBAC
Uterine Volume	Up to Week 12.
Treatment-emergent Adverse Events	Up to Week 16.	Treatment-emergent adverse events are defined as any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through the last visit (Week 16)
Body Weight	Up to Week 12.
Change in menstrual blood loss	Week 12 (one menstrual cycle)	Change in menstrual blood loss measured by PBAC
Other Clinical Symptoms	Up to Week 12.	Assessed by clinical laboratory tests
Serum NTx	Up to Week 12	NTx is one of the biochemical bone metabolism markers