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

• Status: Completed
• Trial end date: 2011-07-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ferring Pharmaceuticals
• Treatments: Misoprostol

Criteria

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.