PRECISION-E2: Teverelix in Women With Endometriosis - Pharmacodynamics, Safety and Precision Medicine Correlates

Korábbi kezelés

• Subject has breast fed in the previous six months
• Subject has a history of previous non-response to Gonadotropin-releasing hormone (GnRH) agonists, GnRH antagonists, Depot Medroxyprogesterone Acetate, or aromatase inhibitors as assessed by subject report of no improvement in dysmenorrhea or non-menstrual pelvic pain (subject report of partial response to or side effects from these agents is not exclusionary).
• Subject has chronic pelvic pain that is not caused by endometriosis that requires chronic analgesic or other chronic therapy, or that would interfere with the assessment of endometriosis related pain.
• Participated in another investigational study within 3 months before recruitment
• Use of the following medications prior to and during study participation:
  • Any other IMP (within 3 months of enrolment)
  • Herbal medications known to have anti-androgenic effects
  • Bethanechol chloride
  • Any other medication or herbal product that may affect hormone levels and might, therefore, confound interpretation of the study results (e.g. St. John's wort) (within 3 months of enrolment)

Más betegség

• Known clinically significant gynaecologic condition, PID, abnormal genital bleeding or uterine anomaly
• Subject has a history of osteoporosis or other metabolic bone disease

Laborértékek

• Has abnormal screening and/or baseline laboratory values that suggest a clinically significant underlying disease, or the following laboratory values:
  • Liver function test (aspartate aminotransferase \[ASAT/SGOT\], alanine aminotransferase \[ALAT/SGPT\]), exceeding \>2X the upper limit of the normal (ULN) range
  • Total bilirubin exceeding \>1.5X the upper limit of the normal (ULN) range
  • An estimated glomerular filtration rate (eGFR) \< 30 mL/min, based on creatinine clearance calculation by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation normalised to an average surface area of 1.73m2, at the screening visit.
• Has congenital long QT syndrome or ECG abnormalities at screening

Egyéb

• Subject is pregnant or breast feeding or is planning a pregnancy within the next 24 months or is less than 6 months postpartum, post-abortion, or post-pregnancy at the time of entry into the Screening Period.
• Bone mineral density by dual energy x-ray absorptiometry Z score of less than -2 at the lumbar spine, total hip or femoral neck
• BMI \<17 or \> 35

• Female between the ages of 19 and 50 (premenopausal)
• Has given written consent
• Clinical diagnosis of endometriosis (laparoscopy or imaging) performed within 5 years of Screening
• The participant must have dysmenorrhea or pelvic pain associated with endometriosis, of which either one or both should be at least "moderate" as determined by the investigator or sub-investigator using the B\&B scale.
• The participant must have maximum VAS score \> 30 for pelvic pain associated with endometriosis
• The participant has experienced a regular menstrual cycle (25 to 38 days) that should include menstrual bleeding of at least 3 consecutive days (at least 3 regular menstrual cycles to be confirmed)
• Agrees to practice contraception, which does not include any form of hormonal contraception during the entire study period:
  • Either by using double barrier contraception and in compliance with local guidelines,
  • or, is truly sexually abstinent, when this is in line with the preferred and usual lifestyle of the patient
• Is not expected to undergo gynaecological surgery or other surgical procedures for treatment of endometriosis (including ablation, shaving, or excision) during the study, including during the Follow-Up Period, and the participant does not desire such treatment during this time frame.
• Agree to continue to use only the analgesic medication permitted by the protocol during the Treatment and Follow-up Periods
• For patients who already participate or are willing to participate in the Emirati Genome Program (EGP, willing to participate in the Pharmacogenomic Study