Trial Outcomes & Findings for Pharmacokinetic (PK) Study of the 200 Microgram (mcg) Misoprostol Vaginal Insert (MVI 200) in Women at Term Gestation (The MVI-PK Study) (NCT NCT01283022)

Last Updated: 2014-04-14

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

24 participants

Primary outcome timeframe

From study drug insertion up to 1 hour post study drug removal.

Results posted on

2014-04-14

Participant Flow

Pregnant women who required to be induced were recruited at 1 site in the US

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	24
Overall Study COMPLETED	24
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Pharmacokinetic (PK) Study of the 200 Microgram (mcg) Misoprostol Vaginal Insert (MVI 200) in Women at Term Gestation (The MVI-PK Study)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	MVI 200 n=24 Participants 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.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	24 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	28.0 years STANDARD_DEVIATION 6.33 • n=5 Participants
Sex: Female, Male Female	24 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Region of Enrollment United States	24 participants n=5 Participants

PRIMARY outcome

Timeframe: From study drug insertion up to 1 hour post study drug removal.

Population: The pharmacokinetic (PK) analysis included all 24 subjects from the Intention-to-Treat (ITT) population.

Outcome measures

Outcome measures
Measure	MVI 200 n=24 Participants 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.
Time of Maximum Plasma Concentration (Tmax) of Misoprostol After Insertion	4 hours Standard Deviation 2.09

PRIMARY outcome

Timeframe: From study drug insertion up to 1 hour post study drug removal

Population: The pharmacokinetic (PK) analysis included all 24 subjects from the Intention-to-Treat (ITT) population.

Outcome measures

Outcome measures
Measure	MVI 200 n=24 Participants 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.
Maximum Plasma Concentration (Cmax) of Misoprostol up to 1 Hour Post Study Drug Removal	45.8 pg/mL Standard Deviation 25.7

SECONDARY outcome

Timeframe: From study drug administration to hospital discharge (approximately 48-72 hours).

Population: The percentage of subjects with adverse events are presented for the Intrapartum (before delivery), postpartum (maternal) and neonatal periods.

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.

Outcome measures

Outcome measures
Measure	MVI 200 n=24 Participants 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.
Rate of Adverse Events. Subjects with Intrapartum Adverse Events	66.7 percentage of participants
Rate of Adverse Events. Subjects with Maternal Postpartum Adverse Events	8.3 percentage of participants
Rate of Adverse Events. Subjects with Neonatal Adverse Events	50.0 percentage of participants

Adverse Events

MVI 200

Serious events: 5 serious events

Other events: 16 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	MVI 200 n=24 participants at risk 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.
Congenital, familial and genetic disorders Cryptorchism *	4.2% 1/24 • Number of events 1 • 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.
Congenital, familial and genetic disorders Hydrocele *	4.2% 1/24 • Number of events 1 • 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.
Pregnancy, puerperium and perinatal conditions Abnormal labour affecting foetus +	4.2% 1/24 • Number of events 1 • 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.
Pregnancy, puerperium and perinatal conditions Foetal heart rate disorder +	8.3% 2/24 • Number of events 2 • 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.
Respiratory, thoracic and mediastinal disorders Infantile apnoeic attack *	4.2% 1/24 • Number of events 1 • 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.
Respiratory, thoracic and mediastinal disorders Neonatal respiratory distress syndrome *	4.2% 1/24 • Number of events 1 • 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.

Other adverse events

Other adverse events
Measure	MVI 200 n=24 participants at risk 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.
Pregnancy, puerperium and perinatal conditions Abnormal labour affecting foetus +	8.3% 2/24 • Number of events 3 • 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.
Pregnancy, puerperium and perinatal conditions Arrested labour +	20.8% 5/24 • Number of events 5 • 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.
Pregnancy, puerperium and perinatal conditions Foetal heart rate disorder +	20.8% 5/24 • Number of events 5 • 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.
Pregnancy, puerperium and perinatal conditions Meconium in amniotic fluid +	20.8% 5/24 • Number of events 5 • 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.
Pregnancy, puerperium and perinatal conditions Umbilical cord around neck *	16.7% 4/24 • Number of events 4 • 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.
Pregnancy, puerperium and perinatal conditions Uterine contractions abnormal +	8.3% 2/24 • Number of events 2 • 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.
Vascular disorders Hypotension +	12.5% 3/24 • Number of events 3 • 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.
Investigations Apgar score low *	8.3% 2/24 • Number of events 2 • 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.
Pregnancy, puerperium and perinatal conditions Caput succedaneum *	8.3% 2/24 • Number of events 2 • 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.
Pregnancy, puerperium and perinatal conditions Cephalohaematoma *	8.3% 2/24 • Number of events 2 • 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.
Surgical and medical procedures Infection prophylaxis *	12.5% 3/24 • Number of events 3 • 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.

Additional Information

Clinical Development Support

Ferring Pharmaceuticals

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee 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.
Publication restrictions are in place

Restriction type: OTHER