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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Recruitment Status : Withdrawn (PK portion will be included in a future protocol)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

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.

Condition or disease Intervention/treatment Phase
Cervical Ripening Induction of Labor Drug: Misoprostol Vaginal Insert (MVI 100) Phase 2

Detailed Description:
PK study in women requiring cervical ripening.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 the National Library of Medicine

Drug Information available for: Misoprostol

Arm Intervention/treatment
Experimental: 1 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




Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. -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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00528255


Locations
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United States, Arizona
Paradise Valley Hospital
Phoenix, Arizona, United States, 85032
United States, California
Long Beach Memorial Hospital
Long Beach, California, United States, 90806
UCI Medical Center
Orange, California, United States, 92868
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
Ferring Pharmaceuticals
Investigators
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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
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Responsible Party: Ferring Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00528255    
Other Study ID Numbers: Miso-Obs-203
First Posted: September 12, 2007    Key Record Dates
Last Update Posted: June 18, 2012
Last Verified: June 2012
Keywords provided by Ferring Pharmaceuticals:
cervical ripening
induction of labor
Additional relevant MeSH terms:
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Misoprostol
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Anti-Ulcer Agents
Gastrointestinal Agents
Oxytocics