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

Induction of Labor Clinical Trial

Official title:

A Multicenter, Open-Label, Phase II Study of the 200 mcg Misoprostol Vaginal Insert (MVI 200) to Obtain Pharmacokinetics in Women at Term Gestation (The MVI-PK Study)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01283022
• Other study ID #: Miso-Obs-205
• Status: Completed
• Phase: Phase 2
• First received: January 20, 2011
• Last updated: March 10, 2014
• Start date: May 2011
• Est. completion date: July 2011

Study information

• Verified date: March 2014
• Source: Ferring Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: July 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Cervical Ripening
• Induction of Labor

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
United States	Huntington Memorial Hospital	Pasadena	California

Sponsors (1)

Lead Sponsor	Collaborator
Ferring Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	From study drug insertion up to 1 hour post study drug removal.	No
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.	From study drug insertion up to 1 hour post study drug removal	No
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.	From study drug administration to hospital discharge (approximately 48-72 hours).	Yes