Merotocin in Mothers With Inadequate Milk Production and Infants Delivered Prematurely

Purpose

Induction and support of lactation in women with preterm delivery and inadequate milk production.

Conditions

  • Preterm Delivery
  • Inadequate Milk Production

Eligibility

Eligible Ages
Between 18 Years and 44 Years
Eligible Genders
Female
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Delivered at the hospital system associated with the trial center - Delivered preterm singleton gestational age 24 weeks + 0 days to 34 weeks + 2 days - Willing to express milk at least 5 times every 24 hours during the observation period and 6 to 8 times every 24 hours during the treatment and post-treatment follow up - Produced < 200 mL milk in 24 hours prior to randomization - Delivered 96 to 192 (+4) hours prior to randomization

Exclusion Criteria

  • Pre-pregnancy body mass index (BMI) > 50 kg/m^2 - Mastitis - History of breast trauma, breast surgery, nipple piercing - Prolactin-releasing pituitary tumor, history of Sheehan's syndrome, pituitary surgery/radiation therapy - Pre-pregnancy insulin-dependent diabetes mellitus, polycystic ovarian syndrome. Note: gestational diabetes is allowed (also when requiring the use of insulin for treatment) - Unstable thyroid disease - Moderate or severe renal or hepatic impairment - Mental illness - Significant nasal congestion or mucous production - Use of anti-psychotic drugs within past 12 months

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Merotocin (a selective oxytocin-receptor agonist)
  • Drug: Merotocin
    Merotocin nasal spray 400 μg/dose, 2 sprays with 1 spray in each nostril administered 6 to 8 times/day (Day 1 to Day 14).
    Other names:
    • FE 202767
Placebo Comparator
Placebo
  • Drug: Placebo
    Placebo nasal spray, 2 sprays with 1 spray in each nostril administered 6 to 8 times/day (Day 1 to Day 14).

More Details

Status
Terminated
Sponsor
Ferring Pharmaceuticals

Study Contact