Skip to main content
OpenTrials
Completed

NCT Number: NCT01458301

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Endometriosis Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Urogenital Diseases

Age range

20 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Nagoya, Aichi-ken, Japan

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Placebo

Drug

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

Drug

TAK-385 10 mg, tablets, orally, once daily and Leuprorelin acetate placebo injection, subcutaneously, once every 4 weeks for up to 12 weeks

Leuprorelin Acetate

Drug

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

Other names: Leuplin

Primary outcomes

  1. Score for pelvic pain as measured by the Visual Analogue Scale (VAS)

    Time frame: Week 12 (one menstrual cycle)

    Pelvic pain will be assessed using the VAS as pain evaluation scale.

Secondary outcomes

  1. VAS Score for Pelvic Pain

    Time frame: Up to Week 12.

    Pelvic pain will be assessed using the VAS as pain evaluation scale

  2. VAS Score for Dyspareunia

    Time frame: Up to Week 12.

    Dyspareunia will be assessed using the VAS as pain evaluation scale

  3. Bone Mineral Density

    Time frame: Up to Week 12.

    Measured by Dual-energy X-ray absorptiometry (DXA)

  4. 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)

  5. Vital Signs

    Time frame: Up to Week 12.

    Vital signs will include body temperature, sitting blood pressure and pulse (bpm).

  6. Body Weight

    Time frame: Up to Week 12.

  7. Electrocardiograms.

    Time frame: Up to Week 12.

  8. Number of Participants with Markedly Abnormal Standard Safety Laboratory Values

    Time frame: Up to Week 24

  9. Serum NTx

    Time frame: Up to Week 12.

    NTx is one of the biochemical bone metabolism markers

  10. Serum BAP

    Time frame: Up to Week 12.

    BAP is one of the biochemical bone metabolism markers

Sponsors and collaborators

Lead sponsor

Takeda

Industry

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Oct 24, 2011
Registry last updated
Feb 25, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.