M18 969 – Endometriosis
- A premenopausal female between 18 and 49 years of age at the time of Screening
- > 39 years of age at entry into Screening must have a normal mammogram (BI-RADS classification 1 to 3 or equivalent)
- must have menstrual cycle lengths of 21 to 35 days for 3 consecutive months prior to Screening.
- must not be breastfeeding, be pregnant, or planning a pregnancy until completion of study participation.
- must be > 6 months post-part um, post-abortion, post-pregnancy, and post-lactation at the time of entry into the Screening Period.
- 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.
- 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.
- 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.
- 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)
- No osteoporosis or other metabolic bone disease, or any condition that would interfere with obtaining adequate DXA measurements.
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