Clinical trial: Placebo-controlled Proof of Concept Study of Epelsiban in Women With Adenomyosis (NCT02794467)

Eligibility criteria:
Inclusion Criteria:

          -  Eighteen to 55 years of age, inclusive

          -  Pre-menopausal with a history of regular menstrual cycles every 21-35 days and without
             intermenstrual bleeding heavier than spotting and staining.

          -  Females with adenomyosis confirmed on magnetic resonance imaging (MRI), - Females with
             heavy menstrual bleeding .

          -  Willing and able to collect all menstrual cycle by-products for each cycle from
             screening to follow up.

          -  Not pregnant as confirmed by a negative serum human chorionic gonadotropin

        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).
Female
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 55 Years

Patient description (medical language): A 43-year-old woman, gravida 3 para 3, comes to the clinic complaining of recently painful menstrual cycles.  The patient's last menstrual period was 2 weeks ago. Urine β-hCG is negative. Menarche was at age 12, and menstrual periods occur every 28 days and lasts for 5 days.  She is sexually active with her husband and does not have pain with intercourse. BMI is 23 kg/m2 and Vital signs are normal.  On physical examination, the uterus is uniformly enlarged and tender. She is candidate for hysterectomy with the diagnosis of adenomyosis.

Patient description (patient's own words): I'm 43, and I paid a visit to my doctor because my last few periods were insanely painful. My last periods were 2 weeks ago. I already had three pregnancies that gave me the three lovely children. I did a urine test to check for potential pregnancy, and it came back negative. I started to have my periods at the age of 12, and I have been pretty regular with periods every 28 days for 5 days. I'm sexually active with my husband and I do not have any pain when we have sex. My BMI is 23 and my vitals were normal. The doctor performed a physical exam and found that my uterus was tender and enlarged. She proposed me a hysterectomy and diagnosed me with adenomyosis.

Does the patient match the trial criteria? Contradiction