Preterm DeliveryPhase 2MERMAIDNCT02545127
Merotocin in Mothers With Inadequate Milk Production and Infants Delivered Prematurely
A Phase 2 study testing Merotocin in people with Preterm Delivery and Inadequate Milk Production, run by Ferring Pharmaceuticals at 10 sites in United States.
Trial summary
Induction and support of lactation in women with preterm delivery and inadequate milk production. Read more about this study
- Who is it for?
- Ages 18 to 44 years, women only
- Conditions the study is for
- Preterm Delivery, Inadequate Milk Production
- What is being tested?
- Merotocin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 4 participants
- Where
- 10 sitesUnited States
- Study dates
- 28 May 2021to 11 Nov 2022
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 44 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- Moderate or severe renal or hepatic impairment
- Mental illness
- Significant nasal congestion or mucous production
- Use of anti-psychotic drugs within past 12 months
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Ferring Investigational Site
Baltimore, Maryland, 21201
Ferring Investigational Site
Boston, Massachusetts, 02115
Ferring Investigational Site
Charleston, South Carolina, 29425
Ferring Investigational Site
Cincinnati, Ohio, 45229
Ferring Investigational Site
Houston, Texas, 77030
Ferring Investigational Site
New Haven, Connecticut, 06520
Ferring Investigational Site
Raleigh, North Carolina, 27610
Ferring Investigational Site
San Antonio, Texas, 78229
Ferring Investigational Site
South Bend, Indiana, 46601
Ferring Investigational Site
Valhalla, New York, 10595
About this study
Official title: 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.
- Conditions
- Preterm Delivery, Inadequate Milk Production
- Being tested
- Merotocin, Placebo
- Keywords
- Inadequate Milk Production
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MerotocinDrug
Also called FE 202767
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).
PlaceboDrug
Placebo nasal spray, 2 sprays with 1 spray in each nostril administered 6 to 8 times/day (Day 1 to Day 14).
| Study group | Role | What they receive |
|---|---|---|
| Merotocin (a selective oxytocin-receptor agonist) | Experimental | Not described Receives: Drug: Merotocin |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Volume of Mother's Own Milk (MoM)
Measured by weight in grams converted to volume in milliliters (mL)
Measured: Daily days 1 to 14
Secondary outcomes (16)
Time to First Occurrence of Daily Volume of MoM ≥ 500 mL
Number of days
Measured: From randomization (Day 1) to Day 14
Time to First Occurrence of Daily Volume of MoM ≥ 750 mL
Number of days
Measured: 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)
Measured: 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)
Measured: Days 1 to 14
Volume of MoM
Measured by weight in grams converted to volume in milliliters (mL)
Measured: Days 15 to 17
Volume of MoM Fed to the Infant
Measured by weight in grams converted to volume in milliliters (mL)
Measured: Days 1 to 14
Volume of Formula/Donor Milk Fed to the Infant
Measured by weight in grams converted to volume in milliliters (mL)
Measured: Days 1 to 14
Merotocin Concentration in Milk
Measured: Day 3
Merotocin Concentration in Milk
Measured: Day 10
Change in Infant Body Weight
Measured: From baseline (Day 1) to Day 14
Frequency of Adverse Events (AEs) in Maternal Participants
Measured: From Screening (0-144 hours of delivery) up to Day 18
Intensity of AEs in Maternal Participants
Measured: From Screening (0-144 hours of delivery) up to Day 18
Frequency of AEs in Infants
Measured: 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
Measured: 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
Measured: From screening up to Day 15
Proportion of Maternal Participants With Markedly Abnormal Changes in Laboratory Values
Measured: From screening up to Day 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2015 (estimated)
- Study start28 May 2021
- Primary completion11 Nov 2022
- Study completion11 Nov 2022
Why it stopped: The trial was prematurely terminated. Termination was not because of safety concerns but due to slow recruitment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Preterm DeliveryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ferring Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Global Clinical Compliance, Study director, Ferring Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02545127
- Sponsor's protocol ID
- 000050
- Acronym
- MERMAID
- Status last verified
- Nov 2022
- First submitted
- 26 Aug 2015
- Last updated
- 7 Feb 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT02545127
- Acronym / sponsor ID
- MERMAID / 000050
- Conditions
- Preterm Delivery, Inadequate Milk Production
- Keywords
- Inadequate Milk Production
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The trial was prematurely terminated. Termination was not because of safety concerns but due to slow recruitment.
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Ferring PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 28 May 2021 (actual)
- Primary completion
- 11 Nov 2022 (actual)
- Study completion
- 11 Nov 2022 (actual)
- First posted
- 9 Sep 2015 (estimated)
- Results
- Posted 7 Feb 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Induction and support of lactation in women with preterm delivery and inadequate milk production.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Merotocin (a selective oxytocin-receptor agonist) | Experimental | Drug: Merotocin |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 44 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (10 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MerotocinAlso: FE 202767Merotocin nasal spray 400 μg/dose, 2 sprays with 1 spray in each nostril administered 6 to 8 times/day (Day 1 to Day 14). | Drug | Merotocin (a selective oxytocin-receptor agonist) |
| PlaceboPlacebo nasal spray, 2 sprays with 1 spray in each nostril administered 6 to 8 times/day (Day 1 to Day 14). | Drug | Placebo |
Primary outcome
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)
16 secondary outcomes
Time to First Occurrence of Daily Volume of MoM ≥ 500 mL
Time frame: 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
Proportion of Participants With a Daily Volume of MoM ≥ 500 mL
Time frame: Days 1 to 14
Proportion of Participants With a Daily Volume of MoM ≥ 750 mL
Time frame: Days 1 to 14
Volume of MoM
Time frame: Days 15 to 17
Volume of MoM Fed to the Infant
Time frame: Days 1 to 14
Volume of Formula/Donor Milk Fed to the Infant
Time frame: Days 1 to 14
Merotocin Concentration in Milk
Time frame: Day 3
Merotocin Concentration in Milk
Time frame: Day 10
Change in Infant Body Weight
Time frame: 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
Intensity of AEs in Maternal Participants
Time frame: 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.
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.
Changes in Routine Safety Laboratory Parameters in Maternal Participants
Time frame: 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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Global Clinical Compliance study director
Ferring Pharmaceuticals
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Merotocin in people with Preterm Delivery and Inadequate Milk Production, run by Ferring Pharmaceuticals at 10 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 7 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Feb 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Volume of Mother's Own Milk (MoM) (time frame: Daily days 1 to 14). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2024.