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Trial record 2 of 4 for:    CLARA Ferring

Pharmacokinetics and Safety of the 100 Mcg Misoprostol Vaginal Insert (MVI 100) (Miso-Obs-203)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00528255
Recruitment Status : Withdrawn (PK portion will be included in a future protocol)
First Posted : September 12, 2007
Last Update Posted : June 18, 2012
Sponsor:
Information provided by (Responsible Party):
Ferring Pharmaceuticals

Tracking Information
First Submitted Date  ICMJE September 10, 2007
First Posted Date  ICMJE September 12, 2007
Last Update Posted Date June 18, 2012
Study Start Date  ICMJE Not Provided
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: September 10, 2007)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 11, 2008)
-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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: September 10, 2007)
-The levels of misoprostol acid in plasma at time of removal, and 30 and 60 minutes post removal. -Assess all adverse events.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pharmacokinetics and Safety of the 100 Mcg Misoprostol Vaginal Insert (MVI 100)
Official Title  ICMJE 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
Brief Summary 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.
Detailed Description PK study in women requiring cervical ripening.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Cervical Ripening
  • Induction of Labor
Intervention  ICMJE 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.
Other Name: Cervical ripener
Study Arms  ICMJE Experimental: 1
Intervention: Drug: Misoprostol Vaginal Insert (MVI 100)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: June 15, 2012)
0
Original Estimated Enrollment  ICMJE
 (submitted: September 10, 2007)
15
Study Completion Date  ICMJE Not Provided
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00528255
Other Study ID Numbers  ICMJE Miso-Obs-203
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ferring Pharmaceuticals
Study Sponsor  ICMJE Ferring Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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 Medical Center
PRS Account Ferring Pharmaceuticals
Verification Date June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP