Trial Exploring the Efficacy and Safety of FE 202767

Inclusion Criteria:

- Provided informed consent for the maternal subject and parental consent for the
infant(s), prior to any trial activity

- Is a maternal subject aged 18 to 44 years

- Delivered at the hospital associated with the trial centre

- Had at least 1 and no more than 2 live-born infants from the current delivery

- Delivered preterm at gestational week 24/0 to 31/6

- Attempted initial milk expression within 12 hours of delivery

- Is willing to express milk 6 to 8 times daily, including at least once during the
night and with no more than 5 hours between milk expression sessions, for up to 23
days during observation, treatment, and follow-up periods

- After the first 24 hours following delivery, attempted milk expression at least 3
times every 24 hours at each consecutive 24-hour interval

- Is willing to refrain from sexual intercourse during the trial

- Has been instructed to express milk 6 to 8 times daily, including at least once
during the night and with no more than 5 hours between milk expression sessions

- Attempted milk expression using the breast pump at least 5 times every 24 hours
during the observation period; note that subjects who entered the observation period
soon after delivery will not be excluded if they pumped less frequently in the first
48 hours after delivery, as long as they have met inclusion criteria 6 and 8

- Accurately recorded timing of milk expression after providing informed consent

- Produced <200 mL milk at the 24-hour baseline interval towards the end of the
observation period, i.e. within 24 hours prior to the last milk expression session
using the breast pump before randomisation

- Delivered 96 to 144 hours prior to randomisation

Exclusion Criteria:

- Has morbidity (chronic or temporary) or other condition or situation that would cause
her to be unable to comply with the protocol or be unable to attend all trial visits

- Has mastitis

- Had known breast trauma, previous breast surgery (including breast augmentation or
breast reduction) or nipple piercing

- Has known prolactin-releasing pituitary tumour, a history of Sheehan's syndrome, or
had previous pituitary surgery or radiation therapy

- Has any known maternally driven contraindication to breast-feeding

- Has severe cardiovascular disease (e.g., uncontrolled hypertension, severe
arrhythmias, or Grade 3-4 New York Heart Association cardiac failure)

- Has pre-pregnancy insulin-dependent diabetes mellitus, polycystic ovarian syndrome,
or any other condition that would impact lactation in the opinion of the investigator

- Has unstable thyroid disease, i.e., has required dose adjustment of thyroid
replacement or anti-thyroid medication in the 12 months prior to delivery

- Has known moderate or severe renal or hepatic impairment

- Has used or is currently using any of the following concomitant medications:

- Atypical anti-psychotic drugs during the previous 12 months (e.g., aripiprazole
[Abilify®], asenapine maleate [Saphris®], clozapine [Clozaril®], iloperidone
[Fanapt®], lurasidone [Latuda®], olanzapine [Zyprexa®], olanzapine/fluoxetine
[Symbyax®], paliperidone [Invega®], quetiapine [Seroquel®], and risperidone
[Risperdal®])

- Any non-registered investigational drugs from 90 days prior to delivery or
within 5 half-lives of the drugs, whichever is longer

- Any hormonal contraception at any point following delivery

- Any pharmacologic or complementary (e.g., herbal) galactagogue therapy at any
point following delivery, including but not limited to oxytocin, prolactin,
metoclopramide, domperidone, sulpiride, fenugreek, shatavari, torbangun, milk
thistle

- Any concomitant medication that could impact lactation (e.g., medications with
an anti-dopamine effect, such as phenothiazine and haloperidol; other
neuroleptics, such as sulpiride and risperidone; the high blood pressure
medication α-methyldopa; and medications used to stimulate intestinal
peristalsis, domperidone, and metoclopramide) at any point following delivery

- Current use of oral steroids at any dose or inhaled steroids at doses >600
µg/day

- Had postpartum haemorrhage of >1500 mL

- Has used or is currently using any of the following concomitant medications:

- Prostaglandins at any point after providing informed consent

- Any current intra-nasally administered concomitant medications

- Methergine from 12 hours prior to randomisation