Merotocin for Inadequate Milk Production

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Inadequate Milk Production+2 More
Merotocin - Drug
Eligibility
18 - 65
Female
What conditions do you have?
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Study Summary

This trial looks at whether a drug can help women with preterm babies and low milk production to make more milk.

Eligible Conditions
  • Inadequate Milk Production
  • Preterm Delivery

Treatment Effectiveness

Study Objectives

1 Primary · 13 Secondary · Reporting Duration: From Screening (0-144 hours of delivery) up to Day 18

Day 1
Volume of mother's own milk (MoM)
Day 10
Merotocin concentration in milk
Days 1 to 14
Proportion of participants with a daily volume of MoM ≥ 500 mL
Proportion of participants with a daily volume of MoM ≥ 750 mL
Volume of MoM fed to the infant
Volume of formula/donor milk fed to the infant
Days 15 to 17
Volume of MoM
Day 18
Frequency and intensity of adverse events (AEs) in maternal participants
Day 14
Change in infant body weight
Day 14
Time to first occurrence of daily volume of MoM ≥ 500 mL
Time to first occurrence of daily volume of MoM ≥ 750 mL
Day 1
Frequency and intensity of AEs in infants
Day 15
Changes in routine safety laboratory parameters in maternal participants
Proportion of maternal participants with markedly abnormal changes in laboratory values

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

2 Treatment Groups

Merotocin (a selective oxytocin-receptor agonist)
1 of 2
Placebo
1 of 2

Experimental Treatment

Non-Treatment Group

100 Total Participants · 2 Treatment Groups

Primary Treatment: Merotocin · Has Placebo Group · Phase 2

Merotocin (a selective oxytocin-receptor agonist)
Drug
Experimental Group · 1 Intervention: Merotocin · Intervention Types: Drug
Placebo
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: from screening (0-144 hours of delivery) up to day 18

Who is running the clinical trial?

Ferring PharmaceuticalsLead Sponsor
301 Previous Clinical Trials
440,040 Total Patients Enrolled
Global Clinical ComplianceStudy DirectorFerring Pharmaceuticals
54 Previous Clinical Trials
357,059 Total Patients Enrolled

Eligibility Criteria

Age 18 - 65 · Female Participants · 5 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are 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.
You are producing less than 200 mL of milk in 24 hours prior to randomization.
You have delivered 96 to 192 hours of care to a child or adolescent aged 18 years or older.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 31st, 2021

Last Reviewed: November 3rd, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.