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Clinical Trials/NCT00828711
NCT00828711CompletedPhase 2

A Multicenter, Randomized, Double-Blind, Dose-Ranging, Phase II Study to Assess the Efficacy and Safety of the 100, 150 and 200 mcg Misoprostol Vaginal Insert for Women Requiring Cervical Ripening and Induction of Labor

Ferring Pharmaceuticals11 sites in 1 country374 target enrollmentStarted: April 2009Last updated:
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Conditions
Interventions

Trial Snapshot

Phase
Phase 2
Status
Completed
Enrollment
374
Locations
11
Primary Endpoint
Proportion of Women Delivering Vaginally
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

The purpose of this study is to assess the efficacy and safety of the 100, 150 and 200 mcg Misoprostol Vaginal Insert (MVI 100, MVI 150 and MVI 200) for women requiring cervical ripening and induction of labor.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
No

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

  • •Nulliparous women participating in the pharmacokinetic (PK) arm of the study: women with hemoglobin level < 11.0 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 fetal abnormalities;
  • •Any evidence of fetal compromise at baseline (e.g., non-reassuring fetal heart rate pattern or meconium staining);
  • •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.

Arms & Interventions

MVI 100

Experimental

MVI 100 mcg vaginal insert

Intervention: MVI 100 (Drug)

MVI 150

Experimental

MVI 150 mcg vaginal insert

Intervention: MVI 150 (Drug)

MVI 200

Experimental

MVI 200 mcg vaginal insert

Intervention: MVI 200 (Drug)

Outcomes

Primary Outcomes

Proportion of Women Delivering Vaginally

Time Frame: Interval from study drug administration to 24 hours

Secondary Outcomes

  • Time to Vaginal Delivery(Interval from study drug administration to delivery (average 24 hours))
  • Rate of Adverse Events(From study drug administration to hospital discharge (approximately 48 - 72 hours))
  • Proportion of Cesarean Delivery(Interval from study drug administration to cesarean delivery (average 24 hours))
  • Cervical Ripening Using Composite Measure of Success(12 hours after insertion of drug)
  • Use of Oxytocin(At least 30 minutes after study drug removal)
  • Time of Maximum Plasma Concentration (Tmax), Maximum Plasma Concentration (Cmax), Area Under the Curve (AUC) and Terminal Half Life of Misoprostol Acid.(From study drug insertion up to 2 hours post study drug removal)
  • Time to Onset of Active Labor(Interval from study drug administration to active labor (average 12 hours))

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (11)

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