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

  • STATUS
    Recruiting
  • End date
    Aug 26, 2021
  • participants needed
    76
  • sponsor
    Mitsubishi Tanabe Pharma Development America, Inc.
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Updated on 26 January 2021
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Investigator
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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.

Details
Condition Endometrial Related Pain
Treatment Placebo, MT-2990
Clinical Study IdentifierNCT03840993
SponsorMitsubishi Tanabe Pharma Development America, Inc.
Last Modified on26 January 2021

Eligibility

 Yes No Not Sure

Inclusion Criteria

Is your age between 18 yrs and 49 yrs?
Are you female?
Do you have Endometrial Related Pain?
Do you have any of these conditions: Do you have Endometrial Related Pain??
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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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