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Miami Clinical Research

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Miami Clinical Research
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  • Phase 2 Extension Study Evaluating Relugolix in Women with Endometriosis-Associated Pain

    Relugolix is an oral, once-daily, small molecule gonadotropin-releasing hormone (GnRH) receptor antagonist and has been evaluated in over 1,300 study participants in Phase 1 and multiple large controlled Phase 2 clinical trials. In these trials, relugolix was generally well tolerated and suppressed estrogen and progesterone levels in women and testosterone levels in men. Common side effects of relugolix are consistent with its mechanism of action in lowering these sex hormones.

    Myovant Sciences has an exclusive, worldwide license (excluding Japan and certain other Asian countries) to develop and commercialize relugolix. Myovant is developing relugolix as an oral, once-daily, GnRH receptor antagonist for heavy menstrual bleeding associated with uterine fibroids, endometriosis-associated pain, and advanced prostate cancer.

    About Endometriosis

    Endometriosis is a disease in which tissue that normally lines the uterus is found outside the uterine cavity, commonly in...

  • Phase 2 Data for Relugolix in Women with Heavy Menstrual Bleeding and Uterine Fibroids

    Phase 2 Study Results

    Relugolix demonstrated statistical significance over placebo in the primary endpoint of the proportion of subjects who had reduction in menstrual blood loss from a score of at least 120 required at study entry to less than 10 from Week 6 through Week 12 on the Pictorial Blood Loss Assessment Chart (PBAC). Relugolix decreased menstrual blood loss in a dose-dependent manner with the highest proportion of responses [84%, 95% confidence interval (74% to 93%) vs. placebo] in the relugolix 40-mg group.

    In the relugolix 40-mg group, 73% of women achieved amenorrhea (i.e. a PBAC score of 0, representing no menstrual blood loss) from Week 6 through Week 12. No women in the placebo group achieved amenorrhea. At Week 12, the 40-mg group demonstrated an absolute reduction in myoma and uterine volumes of approximately 50% from baseline compared to placebo. By Week 12, there was an increase in hemoglobin levels in the relugolix 20- and 40-mg groups compared to...

Information

Demographic Data

  • SITE INFORMATION 
  • Start year clinical research2012
  • Phases of clinical studiesPhase I, Phase II, Phase III, Phase IV
  • Types of studiesBiologics, Drugs, Medical Devices, Nutraceuticals, Vaccines
  • PopulationsInfant 0-1yr, Child 2-10 yrs, Adolescent 11-17 yrs, Adult 18-64 yrs, Senior 65 yrs and over
  • SPECIFIC SITE INFORMATION 
  • Type of sitePart of a practice
  • # of employees involved in research35
  • # of investigators8
  • Number of studies last year35
  • Days openMonday, Tuesday, Wednesday, Thursday, Friday, Saturday
  • Extended office hoursYes
  • Overnight facilitiesYes
  • Dry iceYes
  • Blinded pharmacistYes
  • Dedicated monitoring spaceYes
  • Internet access for the monitorYes
  • Onsite laboratoryYes
  • Central laboratoryYes
  • Infusion capabilityYes
  • Shipping optionsFedEx, UPS, DHL, Other
  • REGULATORY INFORMATION 
  • Contact for regulatory documentsDebbie Shannon
  • Regulatory phone number9545936649
  • # of days to turn around regulatory documentsone week
  • Type of IRB used by this siteCentral
  • Appropriate storage facilities for productYes
  • Able to appropriately store Schedule II drugsYes
  • FINANCIAL INFORMATION 
  • # days to turn around budget and contract7 business days