Endometriosis

This study is currently active

Northern California Research is conducting a study for Endometriosis, the presence of endometrial glands and stroma outside of the uterine cavity. With this a large percentage of women suffer from moderate to severe pelvic pain. This investigational medication is to determine the benefit of decreasing pelvic pain.

  • Study length is 7 months with 10 visits.
  • Age requirement: 18-50 having regular menstrual cycles and experience pain associated with cycles.
  • Must have a diagnosis of endometriosis by way of surgical visualization by laparoscopy or laparotomy performed within 10 years.
  • Agrees to contraception during the trial. Tests being performed at no cost:
    • Labs, ECG’s, Ultrasound, Pap, EMB, physical exams, DEXA and study medication.
  • Compensation up to $1025 for completed clinic visits.
The purpose of this study is to determine the benefit and safety of relugolix 40 mg once daily, co-administered with low-dose estradiol and norethindrone acetate compared with placebo for 24 weeks, on dysmenorrhea and on nonmenstrual pelvic pain.

Eligible patients, including women randomized to placebo, will be offered the opportunity to enroll in a 28-week open label extension study where patients will receive relugolix co-administered with low-dose estradiol and norethindrone acetate. Patients who do not enroll into the extension study will have a Follow-Up visit approximately 30 days after the patient’s last dose of study drug.

Key Inclusion Criteria:

  1. Is a premenopausal female aged 18 to 50 years old (inclusive) on the day of signing of the informed consent form.
  2. Has agreed to use only study-specified analgesic medications during the study and is not known to be intolerant to these.
  3. Has a diagnosis of endometriosis with surgical visualization of endometriosis via laparoscopy or laparotomy performed within 10 years prior to signing the informed consent form.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03204331

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