Phase 2 Completed N=24 Basic Science

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

Cervical Ripening · Induction of Labor

Source: ClinicalTrials.gov NCT01283022 ↗

Enrolled (actual)

Serious AEs

20.8%

Results posted

Apr 2014

Primary outcomePrimary: Time of Maximum Plasma Concentration (Tmax) of Misoprostol After Insertion — 4 hours

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Time of Maximum Plasma Concentration (Tmax) of Misoprostol After Insertion	4	—
PRIMARY Maximum Plasma Concentration (Cmax) of Misoprostol up to 1 Hour Post Study Drug Removal	45.8	—
SECONDARY Rate of Adverse Events.	66.7; 8.3; 50.0	—

Eligibility 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 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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01283022). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.