Pharmacokinetics and Safety of the 100 Mcg Misoprostol Vaginal Insert (MVI 100)
Phase 2
Withdrawn
- Conditions
- Cervical RipeningInduction of Labor
- Interventions
- Registration Number
- NCT00528255
- Lead Sponsor
- 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.
- Detailed Description
PK study in women requiring cervical ripening.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- Female
- Target Recruitment
- Not specified
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 1 Misoprostol Vaginal Insert (MVI 100) -
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method -The levels of misoprostol acid in plasma at time of removal, and 30 and 60 minutes post removal. -Assess all adverse events. 24h
Trial Locations
- Locations (6)
Long Beach Memorial Hospital
🇺🇸Long Beach, California, United States
Paradise Valley Hospital
🇺🇸Phoenix, Arizona, United States
Santa Clara Valley Medical Center
🇺🇸San Jose, California, United States
UCI Medical Center
🇺🇸Orange, California, United States
Jordan Valley Hospital
🇺🇸West Jordan, Utah, United States
Temple University Hospital
🇺🇸Philadelphia, Pennsylvania, United States