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

Endometriosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01458301
• Other study ID #: TAK-385/CCT-101
• Secondary ID: U1111-1123-6890J
• Status: Completed
• Phase: Phase 2
• First received: August 31, 2011
• Last updated: February 24, 2014
• Start date: October 2011
• Est. completion date: August 2013

Study information

• Verified date: February 2014
• Source: Takeda
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 487
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Endometriosis

Intervention

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.
• 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
• 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
• 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
• Leuprorelin acetate
TAK-385 placebo-matching tablets, orally, once daily and Leuprorelin acetate injection, subcutaneously, once every 4 weeks for up to 12 weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Takeda

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Score for pelvic pain as measured by the Visual Analogue Scale (VAS)	Pelvic pain will be assessed using the VAS as pain evaluation scale.	Week 12 (one menstrual cycle)	No
Secondary	VAS Score for Pelvic Pain	Pelvic pain will be assessed using the VAS as pain evaluation scale	Up to Week 12.	No
Secondary	VAS Score for Dyspareunia	Dyspareunia will be assessed using the VAS as pain evaluation scale	Up to Week 12.	No
Secondary	Bone Mineral Density	Measured by Dual-energy X-ray absorptiometry (DXA)	Up to Week 12.	Yes
Secondary	Treatment-emergent Adverse Events.	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)	Up to Week 16	Yes
Secondary	Vital Signs	Vital signs will include body temperature, sitting blood pressure and pulse (bpm).	Up to Week 12.	Yes
Secondary	Body Weight		Up to Week 12.	Yes
Secondary	Electrocardiograms.		Up to Week 12.	Yes
Secondary	Number of Participants with Markedly Abnormal Standard Safety Laboratory Values		Up to Week 24	Yes
Secondary	Serum NTx	NTx is one of the biochemical bone metabolism markers	Up to Week 12.	Yes
Secondary	Serum BAP	BAP is one of the biochemical bone metabolism markers	Up to Week 12.	Yes