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Completed

NCT Number: NCT01452685

A Long-term Extension Study of TAK-385 in the Treatment of Endometriosis

The purpose of this study is to compare the long term safety and efficacy of TAK-385, once daily (QD) following continued administration in participants who completed a Phase II dose-finding study.

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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

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About this study

This study is a long-term extension study for evaluation of the safety and efficacy of TAK-385 following administration for 24 weeks (calculated from Visit 3 in the TAK-385/CCT-101 study) in participants from the Phase II dose-finding study (TAK-385/CCT-101 study).

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Participants who have completed TAK-385/CCT-101 study

Exclusion criteria

  • Participants who had an adverse event in TAK-385/CCT-101 study which makes continued administration of the study drug difficult
  • Participants who became unable to comply with the protocol due to onset of a new disease, symptom, finding, or aggravation of clinical laboratory findings
  • Participants in whom investigator deems that the study drug shows no efficacy based on the level of pain, menstruation status, and the status of analgesic drug intake in TAK-385/CCT-101 study, or that study continuation represents an unacceptable risk
  • Participants in whom investigator deems that study continuation is difficult due to the occurrence of low estrogen symptoms in TAK-385/CCT-101 study which were attributed to the pharmacological effects of the study drug taking into account the level and frequency of the adverse events etc. as well as the risk-benefit of participants.

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 3.75 mg injection, subcutaneously, once every 4 weeks for up to 12 weeks

Other names: Leuplin

Primary outcomes

  1. Bone Mineral Density

    Time frame: Up to Week 24.

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

  2. 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)

  3. Vital Signs

    Time frame: Up to Week 24

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

  4. Body Weight

    Time frame: Up to Week 24

  5. Electrocardiograms

    Time frame: Up to Week 24.

  6. Laboratory Values

    Time frame: Up to Week 24

  7. Serum NTx

    Time frame: Up to Week 24

    NTx is one of the biochemical bone metabolism markers

  8. Serum BAP

    Time frame: Up to Week 24

    BAP is one of the biochemical bone metabolism markers

Secondary outcomes

  1. Visual Analogue Scale (VAS) Score for Pelvic Pain

    Time frame: Up to Week 24

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

  2. VAS Score for Dyspareunia

    Time frame: Up to Week 24

    Dyspareunia will be assessed using the VAS as pain evaluation scale

Sponsors and collaborators

Lead sponsor

Takeda

Industry

Registry information

Official study title

A Phase II, Multicenter, Long-term Extension Study to Compare the Safety and Efficacy of TAK-385 (10, 20, and 40 mg) Following Oral Administration for 12 Weeks or More in the Treatment of Endometriosis

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Oct 17, 2011
Registry last updated
May 8, 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.

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