M18 969 – Endometriosis

Key Inclusion

  1.  A premenopausal female between 18 and 49 years of age at the time of Screening
  2.  > 39 years of age at entry into Screening must have a normal mammogram (BI-RADS   classification 1 to 3 or equivalent)
  3. must have menstrual cycle lengths of 21 to 35 days for 3 consecutive months prior to Screening.
  4. must not be breastfeeding, be pregnant, or planning a pregnancy until completion of study participation.
  5. must be > 6 months post-part um, post-abortion, post-pregnancy, and post-lactation at the time of entry into the Screening Period.
  6. has a documented diagnosis of endometriosis established by visualization (e.g., laparoscopy or laparotomy) or histology prior to entry into the Washout Period (if applicable) or Screening Period.

 

 

Key Exclusion

  1. No surgical history of:
  • Hysterectomy (with or without oophorectomy)
  • Bilateral oophorectomy
  • Major surgery (including laparotomy for endometriosis) within 3 months prior to the initial screening visit
  • Minor surgery (including laparoscopy for endometriosis) within 1 month prior to the initial Screening visit.
  1. Must not be using:
  • A copper intrauterine device (CU-IUD) or levonorgestrel intrauterine system (LNG-IUS) or progesterone-containing implant.
  • Systemic corticosteroids for > 14 days within 3 months prior to Screening or is likely to require use of systemic corticosteroids for > 7 days during study participation.
  • Cannabinoid/marijuana (recreational or medicinal) during Screening through the 3-month double-blind, placebo-controlled Treatment Period.
  • Moderate or strong inducers of cytochrome P450 3A (CYP3A) (e.g., phenobarbital, St. John’s Wort) within 1 month prior to Study Day 1.
  • Strong inhibitors of CYP3A (e.g., ketoconazole, clarithromycin) within 1 month prior to Day 1.
  1. No history or current condition/ diagnosis of:
  • Major psychiatric disorders (e.g., schizophrenia, bipolar disorder)
  • Major depression
  • Undiagnosed abnormal uterine, vaginal, or genital bleeding
  • Drug and/or alcohol abuse within 12 months prior to Screening that may affect the subject’s safety or data collection or may have an adverse effect on her study participation.
  • Any malignancy (including liver cancer, breast cancer, or other hormone-sensitive cancer), with or without systemic chemotherapy (except basal cell carcinoma of the skin)
  1. No osteoporosis or other metabolic bone disease, or any condition that would interfere with obtaining adequate DXA measurements.

 

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