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NCT Number: NCT01283022

Pharmacokinetic (PK) Study of the 200 Microgram (mcg) Misoprostol Vaginal Insert (MVI 200) in Women at Term Gestation (The MVI-PK Study)

The purpose of this study is to determine the pharmacokinetics (PK) of misoprostol acid for the MVI 200 in women requiring cervical ripening and induction of labor.

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Key information

Conditions

Cervical Ripening Induction of Labor

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Huntington Memorial Hospital

Pasadena, California, 91105, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Provide written informed consent;
  • Pregnant women at ≥ 36 weeks 0 days inclusive gestation;
  • Women aged 18 years or older;
  • Candidate for pharmacologic induction of labor;
  • Single, live vertex fetus;
  • Baseline modified Bishop score ≤ 4;
  • Parity ≤ 3 (parity is defined as one or more births live or dead after 24 weeks gestation);
  • Body Mass Index (BMI) ≤ 50 at the time of entry to the study.

Exclusion criteria

  • Women with hemoglobin level < 10.0 grams per deciliter (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 gestational hypertension;
  • Severe pre-eclampsia marked by Hemolytic anemia, Elevated Liver enzymes, Low Platelet count (HELLP) syndrome, other end-organ affliction or Central Nervous System (CNS) findings other than mild headache;
  • Fetal malpresentation;
  • Diagnosed congenital anomalies, not including polydactyly;
  • Any evidence of fetal compromise at baseline (e.g., non-reassuring fetal heart rate pattern or meconium staining);
  • Amnioinfusion or other treatment of non-reassuring fetal status at any time prior to the induction attempt;
  • Ruptured membranes ≥ 48 hours prior to the start of treatment;
  • Suspected chorioamnionitis;
  • Fever (oral or aural temperature > 37.5°C);
  • 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, other prostaglandins or any of the excipients;
  • Any condition urgently requiring delivery;
  • Unable to comply with the protocol.

Treatment and study plan

MVI 200

Drug

Dose reservoir of 200 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 200 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request.

Other names: Misopess (TM), Misodel (R)

Primary outcomes

  1. Time of Maximum Plasma Concentration (Tmax) of Misoprostol After Insertion

    Time frame: From study drug insertion up to 1 hour post study drug removal.

    The timepoints over which the pharmacokinetic measurements were assessed, and deemed as accurate and appropriate, were as follows: 0 hours (baseline), 0.5,1, 2, 4, 6, 8, 10 and 14 hours after insertion of the study drug, immediately prior to removal of the study drug and 0.5 and 1 hour after removal of the study drug. The 10 hour and 14 hour blood samples were obtained if the subject still had the study drug in place at those timepoints.

  2. Maximum Plasma Concentration (Cmax) of Misoprostol up to 1 Hour Post Study Drug Removal

    Time frame: From study drug insertion up to 1 hour post study drug removal

    The timepoints over which the pharmacokinetic measurements were assessed, and deemed as accurate and appropriate, were as follows: 0 hours (baseline), 0.5,1, 2, 4, 6, 8, 10 and 14 hours after insertion of the study drug, immediately prior to removal of the study drug and 0.5 and 1 hour after removal of the study drug. The 10 hour and 14 hour blood samples were obtained if the subject still had the study drug in place at those timepoints.

Secondary outcomes

  1. Rate of Adverse Events.

    Time frame: From study drug administration to hospital discharge (approximately 48-72 hours).

    All adverse events were rated by the Investigator as mild, moderate or severe and classified as having no relationship, possible relationship or a probable relationship to the study drug. These assessments were deemed as accurate and appropriate for the reporting of all serious and non serious adverse events.

Sponsors and collaborators

Lead sponsor

Ferring Pharmaceuticals

Industry

Registry information

Official study title

A Multicenter, Open-Label, Phase II Study of the 200 mcg Misoprostol Vaginal Insert (MVI 200) to Obtain Pharmacokinetics in Women at Term Gestation (The MVI-PK Study)

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Jan 25, 2011
Registry last updated
Apr 14, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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