| Primary | Volume of Mother's Own Milk (MoM) | Measured by weight in grams converted to volume in milliliters (mL) | The trial was prematurely terminated due to slow recruitment. Data (if collected) are not presented in order to protect the privacy of the trial participant(s). | Posted | | | | | | Daily days 1 to 14 | | | | ID | Title | Description |
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| OG000 | Merotocin (a Selective Oxytocin-receptor Agonist) | 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). | | OG001 | Placebo | Placebo: Placebo nasal spray, 2 sprays with 1 spray in each nostril administered 6 to 8 times/day (Day 1 to Day 14). |
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| Secondary | Time to First Occurrence of Daily Volume of MoM ≥ 500 mL | | The trial was prematurely terminated due to slow recruitment. Data (if collected) are not presented in order to protect the privacy of the trial participant(s). | Posted | | | | | | From randomization (Day 1) to Day 14 | | | | ID | Title | Description |
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| OG000 | Merotocin (a Selective Oxytocin-receptor Agonist) | 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). | | OG001 | Placebo | Placebo: Placebo nasal spray, 2 sprays with 1 spray in each nostril administered 6 to 8 times/day (Day 1 to Day 14). |
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| Secondary | Time to First Occurrence of Daily Volume of MoM ≥ 750 mL | | The trial was prematurely terminated due to slow recruitment. Data (if collected) are not presented in order to protect the privacy of the trial participant(s). | Posted | | | | | | From randomization (Day 1) to Day 14 | | | | ID | Title | Description |
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| OG000 | Merotocin (a Selective Oxytocin-receptor Agonist) | 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). | | OG001 | Placebo | Placebo: Placebo nasal spray, 2 sprays with 1 spray in each nostril administered 6 to 8 times/day (Day 1 to Day 14). |
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| Secondary | Proportion of Participants With a Daily Volume of MoM ≥ 500 mL | Measured by weight in grams converted to volume in milliliters (mL) | The trial was prematurely terminated due to slow recruitment. Data (if collected) are not presented in order to protect the privacy of the trial participant(s). | Posted | | | | | | Days 1 to 14 | | | | ID | Title | Description |
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| OG000 | Merotocin (a Selective Oxytocin-receptor Agonist) | 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). | | OG001 | Placebo | Placebo: Placebo nasal spray, 2 sprays with 1 spray in each nostril administered 6 to 8 times/day (Day 1 to Day 14). |
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| Secondary | Proportion of Participants With a Daily Volume of MoM ≥ 750 mL | Measured by weight in grams converted to volume in milliliters (mL) | The trial was prematurely terminated due to slow recruitment. Data (if collected) are not presented in order to protect the privacy of the trial participant(s). | Posted | | | | | | Days 1 to 14 | | | | ID | Title | Description |
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| OG000 | Merotocin (a Selective Oxytocin-receptor Agonist) | 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). | | OG001 | Placebo | Placebo: Placebo nasal spray, 2 sprays with 1 spray in each nostril administered 6 to 8 times/day (Day 1 to Day 14). |
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| Secondary | Volume of MoM | Measured by weight in grams converted to volume in milliliters (mL) | The trial was prematurely terminated due to slow recruitment. Data (if collected) are not presented in order to protect the privacy of the trial participant(s). | Posted | | | | | | Days 15 to 17 | | | | ID | Title | Description |
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| OG000 | Merotocin (a Selective Oxytocin-receptor Agonist) | 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). | | OG001 | Placebo | Placebo: Placebo nasal spray, 2 sprays with 1 spray in each nostril administered 6 to 8 times/day (Day 1 to Day 14). |
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| Secondary | Volume of MoM Fed to the Infant | Measured by weight in grams converted to volume in milliliters (mL) | The trial was prematurely terminated due to slow recruitment. Data (if collected) are not presented in order to protect the privacy of the trial participant(s). | Posted | | | | | | Days 1 to 14 | | | | ID | Title | Description |
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| OG000 | Merotocin (a Selective Oxytocin-receptor Agonist) | 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). | | OG001 | Placebo | Placebo: Placebo nasal spray, 2 sprays with 1 spray in each nostril administered 6 to 8 times/day (Day 1 to Day 14). |
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| Secondary | Volume of Formula/Donor Milk Fed to the Infant | Measured by weight in grams converted to volume in milliliters (mL) | The trial was prematurely terminated due to slow recruitment. Data (if collected) are not presented in order to protect the privacy of the trial participant(s). | Posted | | | | | | Days 1 to 14 | | | | ID | Title | Description |
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| OG000 | Merotocin (a Selective Oxytocin-receptor Agonist) | 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). | | OG001 | Placebo | Placebo: Placebo nasal spray, 2 sprays with 1 spray in each nostril administered 6 to 8 times/day (Day 1 to Day 14). |
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| Secondary | Merotocin Concentration in Milk | | The trial was prematurely terminated due to slow recruitment. Data (if collected) are not presented in order to protect the privacy of the trial participant(s). | Posted | | | | | | Day 3 | | | | ID | Title | Description |
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| OG000 | Merotocin (a Selective Oxytocin-receptor Agonist) | 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). | | OG001 | Placebo | Placebo: Placebo nasal spray, 2 sprays with 1 spray in each nostril administered 6 to 8 times/day (Day 1 to Day 14). |
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| Secondary | Merotocin Concentration in Milk | | The trial was prematurely terminated due to slow recruitment. Data (if collected) are not presented in order to protect the privacy of the trial participant(s). | Posted | | | | | | Day 10 | | | | ID | Title | Description |
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| OG000 | Merotocin (a Selective Oxytocin-receptor Agonist) | 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). | | OG001 | Placebo | Placebo: Placebo nasal spray, 2 sprays with 1 spray in each nostril administered 6 to 8 times/day (Day 1 to Day 14). |
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| Secondary | Change in Infant Body Weight | | The trial was prematurely terminated due to slow recruitment. Data (if collected) are not presented in order to protect the privacy of the trial participant(s). | Posted | | | | | | From baseline (Day 1) to Day 14 | | | | ID | Title | Description |
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| OG000 | Merotocin (a Selective Oxytocin-receptor Agonist) | 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). | | OG001 | Placebo | Placebo: Placebo nasal spray, 2 sprays with 1 spray in each nostril administered 6 to 8 times/day (Day 1 to Day 14). |
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| Secondary | Frequency of Adverse Events (AEs) in Maternal Participants | | | Posted | | Count of Participants | | Participants | | From Screening (0-144 hours of delivery) up to Day 18 | | | | ID | Title | Description |
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| OG000 | Merotocin (a Selective Oxytocin-receptor Agonist) | 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). | | OG001 | Placebo | Placebo: Placebo nasal spray, 2 sprays with 1 spray in each nostril administered 6 to 8 times/day (Day 1 to Day 14). |
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| Secondary | Intensity of AEs in Maternal Participants | | | Posted | | Number | | Severe Adverse Events | | From Screening (0-144 hours of delivery) up to Day 18 | | | | ID | Title | Description |
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| OG000 | Merotocin (a Selective Oxytocin-receptor Agonist) | 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). | | OG001 | Placebo | Placebo: Placebo nasal spray, 2 sprays with 1 spray in each nostril administered 6 to 8 times/day (Day 1 to Day 14). |
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| Secondary | Frequency of AEs in Infants | | | Posted | | Count of Participants | | Participants | | From screening until milk expressed Days 1-14 is consumed/discarded or infant discharged from neonatal intensive care unit (NICU), whichever occurs last. | | | | ID | Title | Description |
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| OG000 | Merotocin (a Selective Oxytocin-receptor Agonist) | 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). | | OG001 | Placebo | Placebo: Placebo nasal spray, 2 sprays with 1 spray in each nostril administered 6 to 8 times/day (Day 1 to Day 14). |
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| Secondary | Intensity of AEs in Infants | | | Posted | | Number | | Adverse Events | | From screening until milk expressed Days 1-14 is consumed/discarded or infant discharged from neonatal intensive care unit (NICU), whichever occurs last. | | | | ID | Title | Description |
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| OG000 | Merotocin (a Selective Oxytocin-receptor Agonist) | 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). | | OG001 | Placebo | Placebo: Placebo nasal spray, 2 sprays with 1 spray in each nostril administered 6 to 8 times/day (Day 1 to Day 14). |
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| Secondary | Changes in Routine Safety Laboratory Parameters in Maternal Participants | | | Posted | | Count of Participants | | Participants | | From screening up to Day 15 | | | | ID | Title | Description |
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| OG000 | Merotocin (a Selective Oxytocin-receptor Agonist) | 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). | | OG001 | Placebo | Placebo: Placebo nasal spray, 2 sprays with 1 spray in each nostril administered 6 to 8 times/day (Day 1 to Day 14). |
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| Secondary | Proportion of Maternal Participants With Markedly Abnormal Changes in Laboratory Values | | | Posted | | Count of Participants | | Participants | | From screening up to Day 15 | | | | ID | Title | Description |
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| OG000 | Merotocin (a Selective Oxytocin-receptor Agonist) | 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). | | OG001 | Placebo | Placebo: Placebo nasal spray, 2 sprays with 1 spray in each nostril administered 6 to 8 times/day (Day 1 to Day 14). |
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