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

Induction of Labor Clinical Trial

— Miso-Obs-203  

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00528255
• Other study ID #: Miso-Obs-203
• Status: Withdrawn
• Phase: Phase 2
• First received: September 10, 2007
• Last updated: June 15, 2012

Study information

• Verified date: June 2012
• Source: Ferring Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Description:

PK study in women requiring cervical ripening.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cervical Ripening
• Induction of Labor

Intervention

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.

Locations

Country	Name	City	State
United States	Long Beach Memorial Hospital	Long Beach	California
United States	UCI Medical Center	Orange	California
United States	Temple University Hospital	Philadelphia	Pennsylvania
United States	Paradise Valley Hospital	Phoenix	Arizona
United States	Santa Clara Valley Medical Center	San Jose	California
United States	Jordan Valley Hospital	West Jordan	Utah

Sponsors (1)

Lead Sponsor	Collaborator
Ferring Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	-The levels of misoprostol acid in plasma at time of removal, and 30 and 60 minutes post removal. -Assess all adverse events.		24h	No