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Safety and Efficacy Study of MT-2990 in Women With Endometriosis

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ClinicalTrials.gov Identifier: NCT03840993
Recruitment Status : Recruiting
First Posted : February 15, 2019
Last Update Posted : February 15, 2019
Sponsor:
Information provided by (Responsible Party):
Mitsubishi Tanabe Pharma Development America, Inc.

Brief Summary:
The purpose of this study is to assess the safety and efficacy of MT-2990 for treatment of moderate to severe endometriosis-related pain in women with surgically diagnosed endometriosis.

Condition or disease Intervention/treatment Phase
Endometrial Related Pain Drug: MT-2990 Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 76 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2, Randomized, Double-blind, Placebo-controlled Study to Assess the Safety and Efficacy of MT-2990 in Women With Endometriosis Experiencing Endometrial Related Pain
Actual Study Start Date : January 15, 2019
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : May 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endometriosis

Arm Intervention/treatment
Experimental: MT-2990
MT-2990, IV, over 16 weeks
Drug: MT-2990
IV

Placebo Comparator: Placebo
Placebo, IV, over 16 weeks
Drug: Placebo
IV




Primary Outcome Measures :
  1. Mean change from Baseline to Week 16 in nonmenstrual pelvic pain using a pain scale ranges from 0 (none) to 3 (severe) [ Time Frame: Baseline to Week 16 ]

Secondary Outcome Measures :
  1. Mean change from Baseline to Week 16 in dysmenorrhea using a pain scale ranges from 0 (none) to 3 (severe) [ Time Frame: Baseline to Week 16 ]
  2. Mean change from Baseline to Week 16 in dyspareunia using a pain scale ranges from 0 (none) to 3 (severe) [ Time Frame: Baseline to Week 16 ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 49 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Provide written informed consent to participate in this study
  • Agree to approximately 90-day washout interval of hormonal therapies, if applicable
  • Have a history of regular menstrual cycles
  • Have a body mass index < 40 kg/m^2 (inclusive)
  • Have documented surgical/laparoscopy diagnosis of endometriosis with 5 years
  • Agree to use 2 forms of nonhormonal contraception throughout the study
  • In the Investigator's opinion, subject is able to understand the nature of the study and any risk involved in participation, and is willing to cooperate and comply with the protocol restrictions and requirements including transvaginal ultrasound.
  • Have moderate to severe endometrial related pain

Exclusion Criteria:

  • Subject is pregnant, breast feeding, or planning a pregnancy.
  • Subject is < 6 months postpartum, postabortion, or post-pregnancy.
  • Have an intrauterine device (IUD). If IUD is removed and subject completes Washout period, subject will be eligible for study participation
  • AST, ALT, or total bilirubin ≥ 2.0 × upper limit of normal (ULN) above the reference range
  • Have immunosuppression due to underlying medical condition
  • QTcF or QTcB ≥ 450 msec or clinically important abnormal findings on the ECG
  • Subject is not up-to-date on breast screening according to current guidelines.
  • Has a surgical history of hysterectomy, bilateral oophorectomy and any other recent major surgery
  • Subject is required more than 2 weeks of continuous use of prohibited long-acting narcotic or immediate release narcotic for treatment of endometriosis-associated pain.
  • Have chronic pelvic pain for nonendometriosis related causes, which require systemic pharmaceutical chronic therapy for pain
  • Have other chronic pain syndrome which require chronic analgesic or other chronic therapy
  • Have a clinically significant gynecologic condition identified on the TVU (e.g., complex ovarian cyst > 3 cm or simple ovarian cyst > 5 cm, clinically significant endometrial pathology, single fibroid ≥ 4 cm or multiple (> 4) fibroids that measure ≥ 2 cm or symptomatic submucosal fibroid of any size
  • Have a current history of undiagnosed abnormal genital bleeding

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03840993


Contacts
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Contact: Clinical Trials Information Desk, to prevent miscommunication, please email: information@mt-pharma-us.com

Locations
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United States, California
Northern California Research Corporation Recruiting
Sacramento, California, United States, 95821
United States, Florida
Future Care Solution Recruiting
Miami, Florida, United States, 33165
United States, Idaho
Advanced Clinical Research - Idaho Recruiting
Boise, Idaho, United States, 83642
United States, Washington
Northwest Clinical Research Center Recruiting
Bellevue, Washington, United States, 98007
Sponsors and Collaborators
Mitsubishi Tanabe Pharma Development America, Inc.
Investigators
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Study Director: Head of Clinical Development, Mitsubishi Tanabe Pharma Development America, Inc.

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Responsible Party: Mitsubishi Tanabe Pharma Development America, Inc.
ClinicalTrials.gov Identifier: NCT03840993     History of Changes
Other Study ID Numbers: MT-2990-A01
First Posted: February 15, 2019    Key Record Dates
Last Update Posted: February 15, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Mitsubishi Tanabe Pharma Development America, Inc.:
Endometriosis

Additional relevant MeSH terms:
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Endometriosis
Genital Diseases, Female