Official Title: “A Multicenter, Open-Label, Phase II Study of the Pharmacokinetics and Safety of the100 Mcg Misoprostol Vaginal Insert (MVI 100) in Women Requiring Cervical Ripening and Induction of Labor”

This study will provide pharmacokinetic data for the MVI 100 (100 mcg) misoprostol vaginal insert when administered to nulliparous women at term gestation requiring cervical ripening and induction of labor.

Study Type: Interventional

Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Pharmacokinetics Study

Study Primary Completion Date: October 2007

PK study in women requiring cervical ripening.

Intervention(s) in this Clinical Trial

• Drug: Misoprostol Vaginal Insert (MVI 100)
  • The MVI 100 is misoprostol 100 mcg, formulated in a sustained release, nonbiodegradeable hydrogel polymer, with a polyester knit retrieval tape; IV oxytocin is permitted ad lib 30 minutes following removal of the MVI assuming no contraindications.

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1

Primary Measures

• The levels of misoprostol acid in plasma at time points 0 (baseline), 2, 4, 6, 8, 10 and 14 hours. Not all patients will have all in situ time points as the insert may be removed earlier for safety or efficacy reasons.
  • Time Frame: 24 Hours
    Safety Issue?: No

Secondary Measures

• -The levels of misoprostol acid in plasma at time of removal, and 30 and 60 minutes post removal. -Assess all adverse events.
  • Time Frame: 24h
    Safety Issue?: No

Inclusion Criteria:

• Pregnant women at ≥36 weeks 0 days inclusive gestation;
• Aged 18 years or older;
• Candidate for pharmacologic induction of labor;
• Singleton pregnancy;
• Baseline modified Bishop score <4 (see Appendix B);
• Nulliparous (nulliparous is defined as no previous births live or dead after 24 weeks gestation);
• Written informed consent.

Exclusion Criteria:

• Women with hemoglobin level < 11.0 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 pregnancy inducted hypertension;
• Severe pre-eclampsia marked by CNS findings, HELLP syndrome, or other end-organ affliction;
• Suspected or confirmed cephalopelvic disproportion and/or fetal malpresentation;
• Diagnosed fetal abnormalities;
• Suspected or confirmed intrauterine growth retardation (less than 10% estimated fetal weight for dates);
• Any evidence of fetal compromise at baseline (e.g., non-reassuring fetal heart rate pattern or meconium staining);
• Receipt of NSAID (including aspirin) within 4 hours of study treatment;
• Ruptured membranes ≥48 hours prior to the start of treatment or suspected chorioamnionitis;
• Fever (oral or aural temperature > 37.5C);
• 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, dinoprostone, other prostaglandins or any of the excipients;
• Any condition urgently requiring delivery;
• Unable to comply with the protocol.

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: Cytokine PharmaSciences

Overall Clinical Trial Officials and Contacts

Steven Wininger, MD Principal Investigator Precision Trials  

Information obtained from ClinicalTrials.gov on August 29, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00528255

Study ID Number: Miso-Obs-203

ClinicalTrials.gov Identifier: NCT00528255

Health Authority: United States: Food and Drug Administration