Efficacy and Safety of TAK-385 in the Treatment of Endometriosis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Takeda
ClinicalTrials.gov Identifier:
NCT01458301
First received: August 31, 2011
Last updated: February 24, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention Phase
Endometriosis
Drug: Placebo
Drug: TAK-385
Drug: Leuprorelin acetate
Phase 2

Study Type: 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
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 Endometriosis

Resource links provided by NLM:


Further study details as provided by Takeda:

Primary Outcome Measures:
  • Score for pelvic pain as measured by the Visual Analogue Scale (VAS) [ Time Frame: Week 12 (one menstrual cycle) ] [ Designated as safety issue: No ]
    Pelvic pain will be assessed using the VAS as pain evaluation scale.


Secondary Outcome Measures:
  • VAS Score for Pelvic Pain [ Time Frame: Up to Week 12. ] [ Designated as safety issue: No ]
    Pelvic pain will be assessed using the VAS as pain evaluation scale

  • VAS Score for Dyspareunia [ Time Frame: Up to Week 12. ] [ Designated as safety issue: No ]
    Dyspareunia will be assessed using the VAS as pain evaluation scale

  • Bone Mineral Density [ Time Frame: Up to Week 12. ] [ Designated as safety issue: Yes ]
    Measured by Dual-energy X-ray absorptiometry (DXA)

  • Treatment-emergent Adverse Events. [ Time Frame: Up to Week 16 ] [ Designated as safety issue: Yes ]
    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)

  • Vital Signs [ Time Frame: Up to Week 12. ] [ Designated as safety issue: Yes ]
    Vital signs will include body temperature, sitting blood pressure and pulse (bpm).

  • Body Weight [ Time Frame: Up to Week 12. ] [ Designated as safety issue: Yes ]
  • Electrocardiograms. [ Time Frame: Up to Week 12. ] [ Designated as safety issue: Yes ]
  • Number of Participants with Markedly Abnormal Standard Safety Laboratory Values [ Time Frame: Up to Week 24 ] [ Designated as safety issue: Yes ]
  • Serum NTx [ Time Frame: Up to Week 12. ] [ Designated as safety issue: Yes ]
    NTx is one of the biochemical bone metabolism markers

  • Serum BAP [ Time Frame: Up to Week 12. ] [ Designated as safety issue: Yes ]
    BAP is one of the biochemical bone metabolism markers


Enrollment: 487
Study Start Date: October 2011
Study Completion Date: August 2013
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo Drug: Placebo
TAK-385 placebo-matching tablets, orally, once daily and Leuprorelin acetate placebo injection, subcutaneously, once every 4 weeks for up to 12 weeks.
Experimental: TAK-385 10 mg QD Drug: TAK-385
TAK-385 10 mg, tablets, orally, once daily and Leuprorelin acetate placebo injection, subcutaneously, once every 4 weeks for up to 12 weeks
Experimental: TAK-385 20 mg QD Drug: TAK-385
TAK-385 20 mg, tablets, orally, once daily and Leuprorelin acetate placebo injection, subcutaneously, once every 4 weeks for up to 12 weeks
Experimental: TAK-385 40 mg QD Drug: TAK-385
TAK-385 40 mg, tablets, orally, once daily and Leuprorelin acetate placebo injection, subcutaneously, once every 4 weeks for up to 12 weeks
Leuplin Drug: Leuprorelin acetate
TAK-385 placebo-matching tablets, orally, once daily and Leuprorelin acetate injection, subcutaneously, once every 4 weeks for up to 12 weeks
Other Name: Leuplin

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 administration for 12 weeks in women with endometriosis.

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Premenopausal women
  2. The participants must have dysmenorrhea and pelvic pain associated with endometriosis.
  3. The participant has experienced a regular menstrual cycle.
  4. The participant has been diagnosed with endometriosis by method a), b), or c).

    • Laparotomy
    • Laparoscopy
    • Chocolate cyst of the ovary confirmed by MRI

Exclusion Criteria:

  1. Participants diagnosed with measurable uterine fibroids with the longest diameter of 3 cm or larger
  2. Participants with lower abdominal pain due to irritable bowel syndrome or severe interstitial cystitis
  3. Participants with a previous or current history of thyroid dysfunction
  4. Participants with current or previous history of pelvic inflammatory disease
  5. Participants with positive PAP smear test result conducted
  6. Participants with a history of panhysterectomy or bilateral oophorectomy
  7. Participants judged by investigator to have marked abnormal uterine bleeding or anovulatory bleeding
  8. Participants with a previous or current history of a malignant tumor
  9. 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
  10. 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
  11. Participants who have been treated with bisphosphonate preparation
  12. 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
  13. Participants with non-diagnosable abnormal genital bleeding
  14. Participants with a previous or current history of osteoporosis, bone mass loss, or other metabolic bone diseases
  15. Participants with clinically significant cardiovascular disease or uncontrollable hypertension
  16. Participants judged by investigator to be inappropriate to participate in this study based on the 12-lead electrocardiogram (ECG) findings
  17. 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01458301

  Show 69 Study Locations
Sponsors and Collaborators
Takeda
Investigators
Study Director: Senior Director Takeda
  More Information

No publications provided

Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT01458301     History of Changes
Other Study ID Numbers: TAK-385/CCT-101, U1111-1123-6890, JapicCTI-111588
Study First Received: August 31, 2011
Last Updated: February 24, 2014
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Takeda:
Drug Therapy

Additional relevant MeSH terms:
Endometriosis
Genital Diseases, Female
Leuprolide
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Antineoplastic Agents, Hormonal
Antineoplastic Agents

ClinicalTrials.gov processed this record on October 19, 2014