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

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).