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

Uterine Fibroids Clinical Trial

Official title:

A Phase II, Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled Study of the Efficacy and Safety of TAK-385 10, 20, and 40 mg (p.o.) in the Treatment of Uterine Fibroids

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01452659
• Other study ID #: TAK-385/CCT-001
• Secondary ID: U1111-1123-6815J
• Status: Completed
• Phase: Phase 2
• First received: August 31, 2011
• Last updated: January 17, 2013
• Start date: October 2011
• Est. completion date: September 2012

Study information

• Verified date: January 2013
• Source: Takeda
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 216
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years and older

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Leiomyoma
• Uterine Fibroids

Intervention

Drug:
• TAK-385
TAK-385 10 mg, tablets, orally, once daily for up to 12 weeks.
• TAK-385
TAK-385 20 mg, tablets, orally, once daily for up to 12 weeks.
• TAK-385
TAK-385 40 mg, tablets, orally, once daily for up to 12 weeks.
• Placebo
TAK-385 placebo-matching tablets, orally, once daily for up to 12 weeks.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Takeda

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Decrease in menstrual blood loss	Blood loss will be assessed using the Pictorial Blood Loss Assessment Chart (PBAC).	Week 12 (one menstrual cycle)	No
Secondary	Decrease in menstrual blood loss	Blood loss will be assessed using PBAC	Up to Week 6	No
Secondary	Decrease in menstrual blood loss	Blood loss will be assessed using PBAC	Up to Week 12.	No
Secondary	Amenorrhea	Amenorrhea will be assessed using PBAC	Week 12 (one menstrual cycle).	No
Secondary	Amenorrhea	Amenorrhea will be assessed using PBAC	Up to Week 6.	No
Secondary	Amenorrhea	Amenorrhea will be assessed using PBAC	Up to Week 12.	No
Secondary	Change in menstrual blood loss	Change in menstrual blood loss measured by PBAC	Week 12 (one menstrual cycle)	No
Secondary	Myoma Volume		Up to Week 12.	No
Secondary	Uterine Volume		Up to Week 12.	No
Secondary	Hemoglobin Concentration in Blood		Up to Week 12.	No
Secondary	Pain Symptom	Measured by Numerical Rating Scale.	Up to Week 12.	No
Secondary	Other Clinical Symptoms	Assessed by clinical laboratory tests	Up to Week 12.	No
Secondary	Quality of Life (QOL) Score	QOL will be assessed using Uterine Fibroid Symptom and Quality of Life (UFS-QOL)	Up to Week 12.	No
Secondary	Bone Mineral Density	Measured by Dual-energy X-ray absorptiometry (DXA)	Up to Week 12.	Yes
Secondary	Treatment-emergent Adverse Events	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)	Up to Week 16.	Yes
Secondary	Vital Signs	Vital signs will include body temperature, sitting blood pressure, and pulse (bpm).	Up to Week 12.	Yes
Secondary	Body Weight		Up to Week 12.	Yes
Secondary	Electrocardiograms	Up to Week 12.		Yes
Secondary	Laboratory Values		Up to Week 12	Yes
Secondary	Serum NTx	NTx is one of the biochemical bone metabolism markers	Up to Week 12	Yes
Secondary	Serum BAP	BAP is one of the biochemical bone metabolism markers	Up to Week 12	Yes