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

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ClinicalTrials.gov Identifier: NCT01452659
Recruitment Status : Completed
First Posted : October 17, 2011
Last Update Posted : January 21, 2013
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Uterine Fibroids Drug: TAK-385 Drug: Placebo Phase 2

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 216 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Study Start Date : October 2011
Actual Primary Completion Date : September 2012
Actual Study Completion Date : September 2012

Arm Intervention/treatment
Experimental: TAK-385 10 mg QD Drug: TAK-385
TAK-385 10 mg, tablets, orally, once daily for up to 12 weeks.

Experimental: TAK-385 20 mg QD Drug: TAK-385
TAK-385 20 mg, tablets, orally, once daily for up to 12 weeks.

Experimental: TAK-385 40 mg QD Drug: TAK-385
TAK-385 40 mg, tablets, orally, once daily for up to 12 weeks.

Placebo Comparator: Placebo Drug: Placebo
TAK-385 placebo-matching tablets, orally, once daily for up to 12 weeks.




Primary Outcome Measures :
  1. Decrease in menstrual blood loss [ Time Frame: Week 12 (one menstrual cycle) ]
    Blood loss will be assessed using the Pictorial Blood Loss Assessment Chart (PBAC).


Secondary Outcome Measures :
  1. Decrease in menstrual blood loss [ Time Frame: Up to Week 6 ]
    Blood loss will be assessed using PBAC

  2. Decrease in menstrual blood loss [ Time Frame: Up to Week 12. ]
    Blood loss will be assessed using PBAC

  3. Amenorrhea [ Time Frame: Week 12 (one menstrual cycle). ]
    Amenorrhea will be assessed using PBAC

  4. Amenorrhea [ Time Frame: Up to Week 6. ]
    Amenorrhea will be assessed using PBAC

  5. Amenorrhea [ Time Frame: Up to Week 12. ]
    Amenorrhea will be assessed using PBAC

  6. Change in menstrual blood loss [ Time Frame: Week 12 (one menstrual cycle) ]
    Change in menstrual blood loss measured by PBAC

  7. Myoma Volume [ Time Frame: Up to Week 12. ]
  8. Uterine Volume [ Time Frame: Up to Week 12. ]
  9. Hemoglobin Concentration in Blood [ Time Frame: Up to Week 12. ]
  10. Pain Symptom [ Time Frame: Up to Week 12. ]
    Measured by Numerical Rating Scale.

  11. Other Clinical Symptoms [ Time Frame: Up to Week 12. ]
    Assessed by clinical laboratory tests

  12. Quality of Life (QOL) Score [ Time Frame: Up to Week 12. ]
    QOL will be assessed using Uterine Fibroid Symptom and Quality of Life (UFS-QOL)

  13. Bone Mineral Density [ Time Frame: Up to Week 12. ]
    Measured by Dual-energy X-ray absorptiometry (DXA)

  14. Treatment-emergent Adverse Events [ Time Frame: 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)

  15. Vital Signs [ Time Frame: Up to Week 12. ]
    Vital signs will include body temperature, sitting blood pressure, and pulse (bpm).

  16. Body Weight [ Time Frame: Up to Week 12. ]
  17. Electrocardiograms
    Up to Week 12.

  18. Laboratory Values [ Time Frame: Up to Week 12 ]
  19. Serum NTx [ Time Frame: Up to Week 12 ]
    NTx is one of the biochemical bone metabolism markers

  20. Serum BAP [ Time Frame: Up to Week 12 ]
    BAP is one of the biochemical bone metabolism markers



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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01452659


Locations
Japan
Chiba-shi, Chiba, Japan
Itchihara-shi, Chiba, Japan
Matsuno-shi, Chiba, Japan
Matsuyama-shi, Ehime, Japan
Nihama-shi, Ehime, Japan
Fukui-shi, Fukui, Japan
Fukuoka-shi, Fukuoka, Japan
Iizuka-shi, Fukuoka, Japan
Yanagigawa-shi, Fukuoka, Japan
Mebashi-shi, Gunma, Japan
Ebetsu-shi, Hokkaido, Japan
Sapporo-shi, Hokkaido, Japan
Amagasaki-shi, Hyogo, Japan
Kobe-shi, Hyogo, Japan
Kamakura-shi, Kanagawa, Japan
Yokohama-shi, Kanagawa, Japan
Oita-shi, Oita, Japan
Ibaraki-shi, Osaka, Japan
Osaka-shi, Osaka, Japan
Sakai-shi, Osaka, Japan
Tondabayashi-shi, Osaka, Japan
Chuo-ku, Tokyo, Japan
Itabashi-ku, Tokyo, Japan
Setagaya-ku, Tokyo, Japan
Shinagawa-ku, Tokyo, Japan
Suginami-ku, Tokyo, Japan
Toyama-shi, Toyama, Japan
Sponsors and Collaborators
Takeda
Investigators
Study Director: Senior Director Takeda

Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT01452659     History of Changes
Other Study ID Numbers: TAK-385/CCT-001
U1111-1123-6815 ( Registry Identifier: WHO )
JapicCTI-111590 ( Registry Identifier: JapicCTI )
First Posted: October 17, 2011    Key Record Dates
Last Update Posted: January 21, 2013
Last Verified: January 2013

Keywords provided by Takeda:
Drug Therapy

Additional relevant MeSH terms:
Leiomyoma
Myofibroma
Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Connective Tissue
Connective Tissue Diseases