Merotocin in Mothers With Inadequate Milk Production and Infants Delivered Prematurely (MERMAID)

A Randomized, Double-blind, Placebo-controlled, Multicenter Trial Exploring the Efficacy and Safety of Intra-nasal Administration of Merotocin in Increasing Milk Production in Maternal Subjects With Preterm Delivery and Inadequate Milk Production

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

Study Overview

• Status: Terminated
• Conditions: Preterm Delivery; Inadequate Milk Production
• Intervention / Treatment: Drug: Merotocin; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 4
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Global Clinical Compliance; Phone Number: 1-888-FERRING (1-888-337-7464); Email: MedqueriesUS@ferring.com

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06520
      • Ferring Investigational Site
  • Indiana
    • South Bend, Indiana, United States, 46601
      • Ferring Investigational Site
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • Ferring Investigational Site
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Ferring Investigational Site
  • New York
    • Valhalla, New York, United States, 10595
      • Ferring Investigational Site
  • North Carolina
    • Raleigh, North Carolina, United States, 27610
      • Ferring Investigational Site
  • Ohio
    • Cincinnati, Ohio, United States, 45229
      • Ferring Investigational Site
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Ferring Investigational Site
  • Texas
    • Houston, Texas, United States, 77030
      • Ferring Investigational Site
    • San Antonio, Texas, United States, 78229
      • Ferring Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 44 years (Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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).
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Volume of Mother's Own Milk (MoM)	Measured by weight in grams converted to volume in milliliters (mL)	Daily days 1 to 14

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Volume of MoM	Measured by weight in grams converted to volume in milliliters (mL)	Days 15 to 17
Time to First Occurrence of Daily Volume of MoM ≥ 500 mL	Number of days	From randomization (Day 1) to Day 14
Time to First Occurrence of Daily Volume of MoM ≥ 750 mL	Number of days	From randomization (Day 1) to Day 14
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
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
Volume of MoM Fed to the Infant	Measured by weight in grams converted to volume in milliliters (mL)	Days 1 to 14
Volume of Formula/Donor Milk Fed to the Infant	Measured by weight in grams converted to volume in milliliters (mL)	Days 1 to 14
Merotocin Concentration in Milk		Day 3
Merotocin Concentration in Milk		Day 10
Change in Infant Body Weight		From baseline (Day 1) to Day 14
Frequency of Adverse Events (AEs) in Maternal Participants		From Screening (0-144 hours of delivery) up to Day 18
Intensity of AEs in Maternal Participants		From Screening (0-144 hours of delivery) up to Day 18
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.
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.
Changes in Routine Safety Laboratory Parameters in Maternal Participants		From screening up to Day 15
Proportion of Maternal Participants With Markedly Abnormal Changes in Laboratory Values		From screening up to Day 15

Collaborators and Investigators

• Sponsor: Ferring Pharmaceuticals
• Investigators: Study Director: Global Clinical Compliance, Ferring Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Actual): May 28, 2021
• Primary Completion (Actual): November 11, 2022
• Study Completion (Actual): November 11, 2022

Study Registration Dates

• First Submitted: August 26, 2015
• First Submitted That Met QC Criteria: September 8, 2015
• First Posted (Estimated): September 9, 2015

Study Record Updates

• Last Update Posted (Estimated): February 7, 2024
• Last Update Submitted That Met QC Criteria: January 15, 2024
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: Inadequate Milk Production
• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Premature Birth
• Other Study ID Numbers: 000050

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No