Placebo-controlled Proof of Concept Study of Epelsiban in Women With Adenomyosis

Exclusion Criteria

• •A female subject will not be eligible for inclusion in this study if any of the following criteria apply:
• •Abnormal gynecological examination other than adenomyosis and/or breast examination requiring intervention within six months of study start
• •Abnormal endometrial biopsy within six months of starting study treatment.
• •History of an endometrial ablation within 12 months of starting study treatment.
• •Uterine artery embolization within six months of starting study treatment.
• •Prior major uterine procedures or any other significant uterine abnormalities on MRI (previous caesarean section, dilation and curettage, and diagnostic hysteroscopy are permitted).
• •Confirmed rectovaginal endometriosis in women who have undergone a prior laparoscopy.
• •Active pelvic infection or current use of an intrauterine device within three months of screening.
• •Women with a history of transfusion for heavy menstrual bleeding within the past 2 years or history of postpartum hemorrhage.
• •Any uterine dimension \>20 centimeter (cm).
• •Other major causes of heavy menstrual bleeding -
• •Use within 3 months or anticipated use of medications that modify reproductive function
• •Use or anticipated use of the following drugs: anticoagulants aminocaproic acid ,or any other medications that affect menstrual bleeding such as tranexamic acid.
• •Use of daily opioid pain medications other than with menses.
• •Hemoglobin \<8 grams (g)/deciliter.
• •History of bleeding disorder or known presence of acquired or inherited thrombophilia, (sickle cell trait individuals are not excluded).