Efficacy and Safety of TAK-385 in the Treatment of Endometriosis - Full Text View

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:

MedlinePlus related topics: Endometriosis Pelvic Pain

Drug Information available for: Leuprorelin Leuprolide acetate

U.S. FDA Resources

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

Estimated Enrollment:	495
Study Start Date:	October 2011
Estimated Primary Completion Date:	April 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:

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 Criteria:

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

Contacts and Locations

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

Contacts

Contact: Takeda Study Registration Call Center

800-778-2860

medicalinformation@tpna.com

Show 69 Study Locations

Sponsors and Collaborators

Takeda Pharmaceutical Company Limited

Investigators

Study Director:

Senior Director

Takeda Pharmaceutical Company Limited

More Information

No publications provided

Responsible Party:	Takeda ( Takeda Pharmaceutical Company Limited )
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:	January 17, 2013
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Keywords provided by Takeda:

Drug Therapy

Additional relevant MeSH terms:

Endometriosis
Genital Diseases, Female
Leuprolide
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses

Pharmacologic Actions
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on June 18, 2013