Status:
COMPLETED
Efficacy and Safety of TAK-385 in the Treatment of Endometriosis
Lead Sponsor:
Takeda
Conditions:
Endometriosis
Eligibility:
FEMALE
20+ years
Phase:
PHASE2
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 endometriosis.
Detailed Description
This Phase II, multicenter, double-blind, randomized, parallel-group, placebo-controlled study will evaluate the efficacy and safety of 3 dose levels (10, 20, and 40 mg) of TAK-385 following oral admi...
Eligibility Criteria
Inclusion
- Premenopausal women
- The participants must have dysmenorrhea and pelvic pain associated with endometriosis.
- The participant has experienced a regular menstrual cycle.
- The participant has been diagnosed with endometriosis by method a), b), or c).
- Laparotomy
- Laparoscopy
- Chocolate cyst of the ovary confirmed by MRI
Exclusion
- Participants diagnosed with measurable uterine fibroids with the longest diameter of 3 cm or larger
- Participants with lower abdominal pain due to irritable bowel syndrome or severe interstitial cystitis
- Participants with a previous or current history of thyroid dysfunction
- Participants with current or previous history of pelvic inflammatory disease
- Participants with positive PAP smear test result conducted
- Participants with a history of panhysterectomy or bilateral oophorectomy
- Participants judged by investigator to have marked abnormal uterine bleeding or anovulatory bleeding
- Participants with a previous or current history of a malignant tumor
- 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
- 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
- Participants who have been treated with bisphosphonate preparation
- Participants with a previous or current history of hypersensitivity or allergy to Leuplin, synthetic LH-RH, LH-RH derivatives, gelatin-containing formulations or food containing gelatin, or have a previous or current history of severe hypersensitivity or severe allergy to other drugs
- Participants with non-diagnosable abnormal genital bleeding
- Participants with a previous or current history of osteoporosis, bone mass loss, or other metabolic bone diseases
- Participants with clinically significant cardiovascular disease or uncontrollable hypertension
- Participants judged by investigator to be inappropriate to participate in this study based on the 12-lead electrocardiogram (ECG) findings
- 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) in the clinical laboratory tests
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2013
Estimated Enrollment :
487 Patients enrolled
Trial Details
Trial ID
NCT01458301
Start Date
October 1 2011
End Date
August 1 2013
Last Update
February 25 2014
Active Locations (69)
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1
Nagoya, Aichi-ken, Japan
2
Chiba, Chiba, Japan
3
Funabashi-shi, Chiba, Japan
4
Ichihara-shi, Chiba, Japan