Merotocin in Mothers With Inadequate Milk Production and Infants Delivered Prematurely

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Preterm Delivery, Inadequate Milk Production

In brief

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

Key facts

Study ID

NCT02545127

Run by

Ferring Pharmaceuticals

People needed

4

Starts

2021-05-28

Expected to finish

2022-11-11

Last updated by the study team

2024-02-07

Who can join

Age: 18 and older, up to 44. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Ferring Investigational Site — New Haven, Connecticut, United States
• Ferring Investigational Site — South Bend, Indiana, United States
• Ferring Investigational Site — Baltimore, Maryland, United States
• Ferring Investigational Site — Boston, Massachusetts, United States
• Ferring Investigational Site — Valhalla, New York, United States
• Ferring Investigational Site — Raleigh, North Carolina, United States
• Ferring Investigational Site — Cincinnati, Ohio, United States
• Ferring Investigational Site — Charleston, South Carolina, United States
• Ferring Investigational Site — Houston, Texas, United States
• Ferring Investigational Site — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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