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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03840993
Recruitment Status : Active, not recruiting
First Posted : February 15, 2019
Last Update Posted : June 8, 2021
Sponsor:
Information provided by (Responsible Party):
Mitsubishi Tanabe Pharma Development America, Inc.

Tracking Information
First Submitted Date  ICMJE February 4, 2019
First Posted Date  ICMJE February 15, 2019
Last Update Posted Date June 8, 2021
Actual Study Start Date  ICMJE January 15, 2019
Actual Primary Completion Date May 13, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 12, 2019)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 12, 2019)
  • 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 ]
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Efficacy Study of MT-2990 in Women With Endometriosis
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Endometrial Related Pain
Intervention  ICMJE
  • Drug: MT-2990
    IV
  • Drug: Placebo
    IV
Study Arms  ICMJE
  • Experimental: MT-2990
    MT-2990, IV, over 16 weeks
    Intervention: Drug: MT-2990
  • Placebo Comparator: Placebo
    Placebo, IV, over 16 weeks
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: February 12, 2019)
76
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 2021
Actual Primary Completion Date May 13, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Provide written informed consent to participate in this study
  • Agree to approximately 30-90 day washout interval of hormonal therapies, if applicable
  • Have a history of regular menstrual cycles
  • Have a body mass index < 45 kg/m^2 (inclusive)
  • Have documented surgical/laparoscopy diagnosis of endometriosis with 10 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.
  • Willing to remove a hormonal intrauterine device (IUD) at least 30 days prior to screening. (Non hormonal IUDs do not have to be removed)
  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 49 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03840993
Other Study ID Numbers  ICMJE MT-2990-A01
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Mitsubishi Tanabe Pharma Development America, Inc.
Study Sponsor  ICMJE Mitsubishi Tanabe Pharma Development America, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Head of Clinical Development, Mitsubishi Tanabe Pharma Development America, Inc.
PRS Account Mitsubishi Tanabe Pharma Development America, Inc.
Verification Date June 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP