Pharmacokinetics and Safety of the 100 Mcg Misoprostol Vaginal Insert (MVI 100) - Full Text View

Sponsor:	Cytokine PharmaSciences
Information provided by:	Cytokine PharmaSciences
ClinicalTrials.gov Identifier:	NCT00528255

Purpose

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.

Condition	Intervention	Phase
Cervical Ripening Induction of Labor	Drug: Misoprostol Vaginal Insert (MVI 100)	Phase II

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

Resource links provided by NLM:

Drug Information available for: Misoprostol

U.S. FDA Resources

Further study details as provided by Cytokine PharmaSciences:

Primary Outcome 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 ] [ Designated as safety issue: No ]

Secondary Outcome 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 ] [ Designated as safety issue: No ]

Estimated Enrollment:

15

Arms	Assigned Interventions
1: Experimental	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.

Detailed Description:

PK study in women requiring cervical ripening.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00528255

Locations

United States, Arizona
Paradise Valley Hospital
Phoenix, Arizona, United States, 85032
United States, California
UCI Medical Center
Orange, California, United States, 92868
Long Beach Memorial Hospital
Long Beach, California, United States, 90806
Santa Clara Valley Medical Center
San Jose, California, United States, 95128
United States, Pennsylvania
Temple University Hospital
Philadelphia, Pennsylvania, United States, 19140
United States, Utah
Jordan Valley Hospital
West Jordan, Utah, United States, 84088

Sponsors and Collaborators

Cytokine PharmaSciences

Investigators

Principal Investigator:	Steven Wininger, MD	Precision Trials
Principal Investigator:	Arlen Jarrett, MD	South Valley Women's Research
Principal Investigator:	Deborah Wing, MD	UCI Medical Center/Long Beach Memorial Hospital
Principal Investigator:	Raymond Brown, MD	Temple University Hospital
Principal Investigator:	James Byrne, MD	Santa Clara Valley Health & Hospital System

More Information

No publications provided

Responsible Party:	Cytokine PharmaSciences ( Barbara Powers )
Study ID Numbers:	Miso-Obs-203
Study First Received:	September 10, 2007
Last Updated:	November 12, 2009
ClinicalTrials.gov Identifier:	NCT00528255 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Cytokine PharmaSciences:

cervical ripening
induction of labor

Additional relevant MeSH terms:

Oxytocics
Therapeutic Uses
Anti-Ulcer Agents
Physiological Effects of Drugs
Abortifacient Agents

Misoprostol
Gastrointestinal Agents
Reproductive Control Agents
Abortifacient Agents, Nonsteroidal
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 08, 2010