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

Phase 2

Completed

• Conditions: Cervical Ripening; Induction of Labor
• Interventions: Drug: MVI 200

• Registration Number: NCT01283022
• Lead Sponsor: Ferring Pharmaceuticals

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-01-20
• Study First Submitted QC: 2011-01-24
• Study First Posted: 2011-01-25
• Study Start: 2011-05
• Primary Completion: 2011-07
• Study Completion: 2011-07
• Disposition First Submitted: 2012-07-16
• Disposition First Submitted QC: 2012-07-16
• Disposition First Posted: 2012-07-25
• Results First Submitted: 2014-01-24
• Status Verified: 2014-03
• Results First Submitted QC: 2014-03-10
• Last Update Submitted: 2014-03-10
• Results First Posted: 2014-04-14
• Last Update Posted: 2014-04-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 24

Inclusion Criteria

• Provide written informed consent;
• Pregnant women at ≥ 36 weeks 0 days inclusive gestation;
• Women aged 18 years or older;
• Candidate for pharmacologic induction of labor;
• Single, live vertex fetus;
• Baseline modified Bishop score ≤ 4;
• Parity ≤ 3 (parity is defined as one or more births live or dead after 24 weeks gestation);
• Body Mass Index (BMI) ≤ 50 at the time of entry to the study.

Exclusion Criteria

• Women with hemoglobin level < 10.0 grams per deciliter (g/dL) (confirmed within one week of study drug insertion);
• Women in active labor;
• Presence of uterine or cervical scar or uterine abnormality e.g., bicornate uterus. Biopsies, including cone biopsy of the cervix, are permitted;
• Administration of oxytocin or any cervical ripening or labor inducing agents (including mechanical methods) or a tocolytic drug within 7 days prior to enrollment. Magnesium sulfate is permitted if prescribed as treatment for pre-eclampsia or gestational hypertension;
• Severe pre-eclampsia marked by Hemolytic anemia, Elevated Liver enzymes, Low Platelet count (HELLP) syndrome, other end-organ affliction or Central Nervous System (CNS) findings other than mild headache;
• Fetal malpresentation;
• Diagnosed congenital anomalies, not including polydactyly;
• Any evidence of fetal compromise at baseline (e.g., non-reassuring fetal heart rate pattern or meconium staining);
• Amnioinfusion or other treatment of non-reassuring fetal status at any time prior to the induction attempt;
• Ruptured membranes ≥ 48 hours prior to the start of treatment;
• Suspected chorioamnionitis;
• Fever (oral or aural temperature > 37.5°C);
• Any condition in which vaginal delivery is contraindicated e.g., placenta previa or any unexplained genital bleeding at any time after 24 weeks during this pregnancy;
• Known or suspected allergy to misoprostol, other prostaglandins or any of the excipients;
• Any condition urgently requiring delivery;
• Unable to comply with the protocol.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
MVI 200	MVI 200	MVI 200 mcg vaginal insert

Primary Outcome Measures

Name	Time	Method
Time of Maximum Plasma Concentration (Tmax) of Misoprostol After Insertion	From study drug insertion 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.
Maximum Plasma Concentration (Cmax) of Misoprostol up to 1 Hour Post Study Drug Removal	From study drug insertion 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.

Secondary Outcome Measures

Name	Time	Method
Rate of Adverse Events.	From study drug administration to hospital discharge (approximately 48-72 hours).	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.

Trial Locations

Locations (1)

Huntington Memorial Hospital; 🇺🇸 Pasadena, California, United States