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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


Phase 2
20 Years
N/A
Not Enrolling
Female
Uterine Fibroids

Thank you

Trial Information

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


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.


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)

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Decrease in menstrual blood loss

Outcome Description:

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

Outcome Time Frame:

Week 12 (one menstrual cycle)

Safety Issue:

No

Principal Investigator

Senior Director

Investigator Role:

Study Director

Investigator Affiliation:

Takeda Pharmaceutical Company Limited

Authority:

Japan: Ministry of Health, Labor and Welfare

Study ID:

TAK-385/CCT-001

NCT ID:

NCT01452659

Start Date:

October 2011

Completion Date:

September 2012

Related Keywords:

  • Uterine Fibroids
  • Drug Therapy
  • Leiomyoma
  • Myofibroma

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