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The purpose of this study is to determine the pharmacokinetics (PK) of misoprostol acid for the MVI 200 in women requiring cervical ripening and induction of labor.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MVI 200 | Experimental | MVI 200 mcg vaginal insert |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MVI 200 | Drug | Dose reservoir of 200 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 200 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request. |
| Measure | Description | Time Frame |
|---|---|---|
| Time of Maximum Plasma Concentration (Tmax) of Misoprostol After Insertion | The timepoints over which the pharmacokinetic measurements were assessed, and deemed as accurate and appropriate, were as follows: 0 hours (baseline), 0.5,1, 2, 4, 6, 8, 10 and 14 hours after insertion of the study drug, immediately prior to removal of the study drug and 0.5 and 1 hour after removal of the study drug. The 10 hour and 14 hour blood samples were obtained if the subject still had the study drug in place at those timepoints. | From study drug insertion up to 1 hour post study drug removal. |
| Maximum Plasma Concentration (Cmax) of Misoprostol up to 1 Hour Post Study Drug Removal | The timepoints over which the pharmacokinetic measurements were assessed, and deemed as accurate and appropriate, were as follows: 0 hours (baseline), 0.5,1, 2, 4, 6, 8, 10 and 14 hours after insertion of the study drug, immediately prior to removal of the study drug and 0.5 and 1 hour after removal of the study drug. The 10 hour and 14 hour blood samples were obtained if the subject still had the study drug in place at those timepoints. | From study drug insertion up to 1 hour post study drug removal |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Adverse Events. | All adverse events were rated by the Investigator as mild, moderate or severe and classified as having no relationship, possible relationship or a probable relationship to the study drug. These assessments were deemed as accurate and appropriate for the reporting of all serious and non serious adverse events. | From study drug administration to hospital discharge (approximately 48-72 hours). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Development Support | Ferring Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Huntington Memorial Hospital | Pasadena | California | 91105 | United States |
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Pregnant women who required to be induced were recruited at 1 site in the US
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| ID | Title | Description |
|---|---|---|
| FG000 | MVI 200 | MVI 200 : Dose reservoir of 200 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 200 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | MVI 200 | MVI 200 : Dose reservoir of 200 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 200 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Time of Maximum Plasma Concentration (Tmax) of Misoprostol After Insertion | The timepoints over which the pharmacokinetic measurements were assessed, and deemed as accurate and appropriate, were as follows: 0 hours (baseline), 0.5,1, 2, 4, 6, 8, 10 and 14 hours after insertion of the study drug, immediately prior to removal of the study drug and 0.5 and 1 hour after removal of the study drug. The 10 hour and 14 hour blood samples were obtained if the subject still had the study drug in place at those timepoints. | The pharmacokinetic (PK) analysis included all 24 subjects from the Intention-to-Treat (ITT) population. | Posted | Median | Standard Deviation | hours | From study drug insertion up to 1 hour post study drug removal. |
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All adverse events were followed until resolution or for at least 30 days after discontinuation of study drug, whichever occurred first.
All adverse events occurring to the maternal-fetal unit (pre-delivery/ intrapartum), the mother (postpartum) or the neonate were recorded. Adverse events that resulted in a cesarean delivery were reported as serious adverse events as they were medically significant events that routinely prolonged the duration of hospitalization.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | MVI 200 | MVI 200 : Dose reservoir of 200 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 200 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cryptorchism * | Congenital, familial and genetic disorders | MedDRA (13.1) | Systematic Assessment | * Neonatal Event |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abnormal labour affecting foetus + | Pregnancy, puerperium and perinatal conditions | MedDRA (13.1) | Systematic Assessment | + Intrapartum Event |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Development Support | Ferring Pharmaceuticals | DK0-Disclosure@ferring.com |
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|
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Secondary | Rate of Adverse Events. | All adverse events were rated by the Investigator as mild, moderate or severe and classified as having no relationship, possible relationship or a probable relationship to the study drug. These assessments were deemed as accurate and appropriate for the reporting of all serious and non serious adverse events. | The percentage of subjects with adverse events are presented for the Intrapartum (before delivery), postpartum (maternal) and neonatal periods. | Posted | Number | percentage of participants | From study drug administration to hospital discharge (approximately 48-72 hours). |
|
|
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| Primary | Maximum Plasma Concentration (Cmax) of Misoprostol up to 1 Hour Post Study Drug Removal | The timepoints over which the pharmacokinetic measurements were assessed, and deemed as accurate and appropriate, were as follows: 0 hours (baseline), 0.5,1, 2, 4, 6, 8, 10 and 14 hours after insertion of the study drug, immediately prior to removal of the study drug and 0.5 and 1 hour after removal of the study drug. The 10 hour and 14 hour blood samples were obtained if the subject still had the study drug in place at those timepoints. | The pharmacokinetic (PK) analysis included all 24 subjects from the Intention-to-Treat (ITT) population. | Posted | Median | Standard Deviation | pg/mL | From study drug insertion up to 1 hour post study drug removal |
|
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| 5 |
| 24 |
| 16 |
| 24 |
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| Hydrocele * | Congenital, familial and genetic disorders | MedDRA (13.1) | Systematic Assessment | * Neonatal Event |
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| Abnormal labour affecting foetus + | Pregnancy, puerperium and perinatal conditions | MedDRA (13.1) | Systematic Assessment | + Intrapartum Event |
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| Foetal heart rate disorder + | Pregnancy, puerperium and perinatal conditions | MedDRA (13.1) | Systematic Assessment | + Intrapartum Event |
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| Infantile apnoeic attack * | Respiratory, thoracic and mediastinal disorders | MedDRA (13.1) | Systematic Assessment | * Neonatal Event |
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| Neonatal respiratory distress syndrome * | Respiratory, thoracic and mediastinal disorders | MedDRA (13.1) | Systematic Assessment | * Neonatal Event |
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| Arrested labour + | Pregnancy, puerperium and perinatal conditions | MedDRA (13.1) | Systematic Assessment | + Intrapartum Event |
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| Foetal heart rate disorder + | Pregnancy, puerperium and perinatal conditions | MedDRA (13.1) | Systematic Assessment | + Intrapartum Event |
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| Meconium in amniotic fluid + | Pregnancy, puerperium and perinatal conditions | MedDRA (13.1) | Systematic Assessment | + Intrapartum Event |
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| Umbilical cord around neck * | Pregnancy, puerperium and perinatal conditions | MedDRA (13.1) | Systematic Assessment | * Neonatal Event |
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| Uterine contractions abnormal + | Pregnancy, puerperium and perinatal conditions | MedDRA (13.1) | Systematic Assessment | + Intrapartum Event |
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| Hypotension + | Vascular disorders | MedDRA (13.1) | Systematic Assessment | + Intrapartum Event |
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| Apgar score low * | Investigations | MedDRA (13.1) | Systematic Assessment | * Neonatal Event |
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| Caput succedaneum * | Pregnancy, puerperium and perinatal conditions | MedDRA (13.1) | Systematic Assessment | * Neonatal Event |
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| Cephalohaematoma * | Pregnancy, puerperium and perinatal conditions | MedDRA (13.1) | Systematic Assessment | * Neonatal Event |
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| Infection prophylaxis * | Surgical and medical procedures | MedDRA (13.1) | Systematic Assessment | * Neonatal Event |
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Any abstract,presentation or manuscript proposed for publication must be submitted to the Sponsor for review at least 30 days prior to submission for any meeting or journal.If deemed necessary by the Sponsor for protection of proprietary information prior to patent filing,the Investigator agrees to a further delay of 60 days before any presentation or publication is submitted.Publications must be in a form that does not reveal technical information that is considered confidential or proprietary.
| Title | Measurements |
|---|---|
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