Pharmacokinetics and Safety of the 100 Mcg Misoprostol Vaginal Insert (MVI 100)

NCT00528255 | Withdrawn Phase 2

• 1 other identifier: Miso-Obs-203
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 6

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.

Conditions

Cervical Ripening; Induction of Labor

Keywords

cervical ripening; induction of labor

Outcome Measures

Primary Outcomes (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.

  24 Hours

Secondary Outcomes (1)

• -The levels of misoprostol acid in plasma at time of removal, and 30 and 60 minutes post removal. -Assess all adverse events.

  24h

Study Arms (1)

1

EXPERIMENTAL

Drug: Misoprostol Vaginal Insert (MVI 100)

Interventions

Misoprostol Vaginal Insert (MVI 100) DRUG

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.

Also known as: Cervical ripener

1

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Ferring Pharmaceuticals: lead

Study Sites (6)

Paradise Valley Hospital

Phoenix, Arizona, 85032, United States

Location

Long Beach Memorial Hospital

Long Beach, California, 90806, United States

Location

UCI Medical Center

Orange, California, 92868, United States

Location

Santa Clara Valley Medical Center

San Jose, California, 95128, United States

Location

Temple University Hospital

Philadelphia, Pennsylvania, 19140, United States

Location

Jordan Valley Hospital

West Jordan, Utah, 84088, United States

Location

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2007
• First Posted: September 12, 2007
• Last Updated: June 18, 2012

Record last verified: 2012-06

Locations

US (6)