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

January 15, 2024 updated by: Ferring Pharmaceuticals

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

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
4

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Volume of Mother's Own Milk (MoM)
Time Frame: Daily days 1 to 14
Measured by weight in grams converted to volume in milliliters (mL)
Daily days 1 to 14

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Volume of MoM
Time Frame: Days 15 to 17
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
Time Frame: From randomization (Day 1) to Day 14
Number of days
From randomization (Day 1) to Day 14
Time to First Occurrence of Daily Volume of MoM ≥ 750 mL
Time Frame: From randomization (Day 1) to Day 14
Number of days
From randomization (Day 1) to Day 14
Proportion of Participants With a Daily Volume of MoM ≥ 500 mL
Time Frame: Days 1 to 14
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
Time Frame: Days 1 to 14
Measured by weight in grams converted to volume in milliliters (mL)
Days 1 to 14
Volume of MoM Fed to the Infant
Time Frame: Days 1 to 14
Measured by weight in grams converted to volume in milliliters (mL)
Days 1 to 14
Volume of Formula/Donor Milk Fed to the Infant
Time Frame: Days 1 to 14
Measured by weight in grams converted to volume in milliliters (mL)
Days 1 to 14
Merotocin Concentration in Milk
Time Frame: Day 3
Day 3
Merotocin Concentration in Milk
Time Frame: Day 10
Day 10
Change in Infant Body Weight
Time Frame: From baseline (Day 1) to Day 14
From baseline (Day 1) to Day 14
Frequency of Adverse Events (AEs) in Maternal Participants
Time Frame: From Screening (0-144 hours of delivery) up to Day 18
From Screening (0-144 hours of delivery) up to Day 18
Intensity of AEs in Maternal Participants
Time Frame: From Screening (0-144 hours of delivery) up to Day 18
From Screening (0-144 hours of delivery) up to Day 18
Frequency of AEs in Infants
Time Frame: From screening until milk expressed Days 1-14 is consumed/discarded or infant discharged from neonatal intensive care unit (NICU), whichever occurs last.
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
Time Frame: From screening until milk expressed Days 1-14 is consumed/discarded or infant discharged from neonatal intensive care unit (NICU), whichever occurs last.
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
Time Frame: From screening up to Day 15
From screening up to Day 15
Proportion of Maternal Participants With Markedly Abnormal Changes in Laboratory Values
Time Frame: From screening up to Day 15
From screening up to Day 15

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ferring Pharmaceuticals

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Global Clinical Compliance, Ferring Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 28, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 11, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 11, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 26, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 8, 2015

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 9, 2015

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 7, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 15, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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