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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02545127
Other study ID # 000050
Secondary ID
Status Terminated
Phase Phase 2
First received
Last updated
Start date May 28, 2021
Est. completion date November 11, 2022

Study information

Verified date November 2022
Source Ferring Pharmaceuticals
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Recruitment information / eligibility

Status Terminated
Enrollment 4
Est. completion date November 11, 2022
Est. primary completion date November 11, 2022
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 44 Years
Eligibility 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


Intervention

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).
Placebo
Placebo nasal spray, 2 sprays with 1 spray in each nostril administered 6 to 8 times/day (Day 1 to Day 14).

Locations

Country Name City State
United States Ferring Investigational Site Baltimore Maryland
United States Ferring Investigational Site Boston Massachusetts
United States Ferring Investigational Site Charleston South Carolina
United States Ferring Investigational Site Cincinnati Ohio
United States Ferring Investigational Site Houston Texas
United States Ferring Investigational Site New Haven Connecticut
United States Ferring Investigational Site Raleigh North Carolina
United States Ferring Investigational Site San Antonio Texas
United States Ferring Investigational Site South Bend Indiana
United States Ferring Investigational Site Valhalla New York

Sponsors (1)

Lead Sponsor Collaborator
Ferring Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Volume of Mother's Own Milk (MoM) Measured by weight in grams converted to volume in milliliters (mL) Daily days 1 to 14
Secondary Time to First Occurrence of Daily Volume of MoM = 500 mL Number of days From randomization (Day 1) to Day 14
Secondary Time to First Occurrence of Daily Volume of MoM = 750 mL Number of days From randomization (Day 1) to Day 14
Secondary Proportion of Participants With a Daily Volume of MoM = 500 mL Measured by weight in grams converted to volume in milliliters (mL) Days 1 to 14
Secondary Proportion of Participants With a Daily Volume of MoM = 750 mL Measured by weight in grams converted to volume in milliliters (mL) Days 1 to 14
Secondary Volume of MoM Measured by weight in grams converted to volume in milliliters (mL) Days 15 to 17
Secondary Volume of MoM Fed to the Infant Measured by weight in grams converted to volume in milliliters (mL) Days 1 to 14
Secondary Volume of Formula/Donor Milk Fed to the Infant Measured by weight in grams converted to volume in milliliters (mL) Days 1 to 14
Secondary Merotocin Concentration in Milk Day 3
Secondary Merotocin Concentration in Milk Day 10
Secondary Change in Infant Body Weight From baseline (Day 1) to Day 14
Secondary Frequency of Adverse Events (AEs) in Maternal Participants From Screening (0-144 hours of delivery) up to Day 18
Secondary Intensity of AEs in Maternal Participants From Screening (0-144 hours of delivery) up to Day 18
Secondary Frequency of AEs in Infants From screening until milk expressed Days 1-14 is consumed/discarded or infant discharged from neonatal intensive care unit (NICU), whichever occurs last.
Secondary Intensity of AEs in Infants From screening until milk expressed Days 1-14 is consumed/discarded or infant discharged from neonatal intensive care unit (NICU), whichever occurs last.
Secondary Changes in Routine Safety Laboratory Parameters in Maternal Participants From screening up to Day 15
Secondary Proportion of Maternal Participants With Markedly Abnormal Changes in Laboratory Values From screening up to Day 15
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