Safety and Efficacy Study of MT-2990 in Women With Endometriosis (NCT03840993) | Clinical Trial Compass
CompletedPhase 2
Safety and Efficacy Study of MT-2990 in Women With Endometriosis
United States76 participantsStarted 2019-01-15
Plain-language 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.
Who can participate
Age range18 Years – 49 Years
SexFEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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)
* Aspartate aminotransferase (AST), alanine aminotransferase (ALT) , or total bilirubin ≥ 2.0 × upper limit of normal (ULN) above the reference range
* Have immunosuppression due to underlying medical condition
* Corrected QT interval using Fridericia's formula (QTcF) or Corrected QT interval using Bazett's formula (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 surg…
What they're measuring
1
Mean Change From Baseline to Week 16 in Nonmenstrual Pelvic Pain Using a Pain Scale Ranges From 0 (None) to 3 (Severe)