Misoprostol Vaginal Insert (MVI) 100, 150, 200 mcg for Cervical Ripening and Induction of Labor

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ferring Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00828711
First received: January 22, 2009
Last updated: March 10, 2014
Last verified: March 2014
  Purpose

The purpose of this study is to assess the efficacy and safety of the 100, 150 and 200 mcg Misoprostol Vaginal Insert (MVI 100, MVI 150 and MVI 200) for women requiring cervical ripening and induction of labor.


Condition Intervention Phase
Cervical Ripening
Induction of Labor
Drug: MVI 100
Drug: MVI 150
Drug: MVI 200
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Double-Blind, Dose-Ranging, Phase II Study to Assess the Efficacy and Safety of the 100, 150 and 200 mcg Misoprostol Vaginal Insert for Women Requiring Cervical Ripening and Induction of Labor

Resource links provided by NLM:


Further study details as provided by Ferring Pharmaceuticals:

Primary Outcome Measures:
  • Proportion of Women Delivering Vaginally [ Time Frame: Interval from study drug administration to 24 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to Vaginal Delivery [ Time Frame: Interval from study drug administration to delivery (average 24 hours) ] [ Designated as safety issue: No ]
  • Rate of Adverse Events [ Time Frame: From study drug administration to hospital discharge (approximately 48 - 72 hours) ] [ Designated as safety issue: Yes ]
    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.

  • Proportion of Cesarean Delivery [ Time Frame: Interval from study drug administration to cesarean delivery (average 24 hours) ] [ Designated as safety issue: Yes ]
  • Cervical Ripening Using Composite Measure of Success [ Time Frame: 12 hours after insertion of drug ] [ Designated as safety issue: No ]

    Cervical ripening success was defined by achievement of one or more of the following by 12 hours after study drug administration:

    • Increase from baseline in modified Bishop score ≥3; or
    • Achievement of modified Bishop score of ≥6; or
    • Vaginal delivery.

  • Use of Oxytocin [ Time Frame: At least 30 minutes after study drug removal ] [ Designated as safety issue: No ]
    Percentage of participants in receipt of Oxytocin for induction after study drug removal is accurate and appropriate for this outcome measure.

  • Time of Maximum Plasma Concentration (Tmax), Maximum Plasma Concentration (Cmax), Area Under the Curve (AUC) and Terminal Half Life of Misoprostol Acid. [ Time Frame: From study drug insertion up to 2 hours post study drug removal ] [ Designated as safety issue: No ]
    The timepoints over which the pharmacokinetic measurements were assessed, and deemed as accurate and appropriate, were as follows: 0 hours (baseline), 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, 1 and 2 hours after removal of the study drug.

  • Time to Onset of Active Labor [ Time Frame: Interval from study drug administration to active labor (average 12 hours) ] [ Designated as safety issue: No ]

Enrollment: 374
Study Start Date: April 2009
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MVI 100
MVI 100 mcg vaginal insert
Drug: MVI 100
Dose reservoir of 100 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 100 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)
Experimental: MVI 150
MVI 150 mcg vaginal insert
Drug: MVI 150
Dose reservoir of 150 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 150 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)
Experimental: MVI 200
MVI 200 mcg vaginal insert
Drug: MVI 200
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)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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:

  • Nulliparous women participating in the pharmacokinetic (PK) arm of the study: women with hemoglobin level < 11.0 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 fetal abnormalities;
  • Any evidence of fetal compromise at baseline (e.g., non-reassuring fetal heart rate pattern or meconium staining);
  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00828711

Locations
United States, Arizona
Precision Trials
Phoenix, Arizona, United States, 85032
Tuscon Medical Center
Tucson, Arizona, United States, 85716
United States, California
Long Beach Memorial Medical Center
Long Beach, California, United States, 90806
UCI Medical Center
Orange, California, United States, 92868
United States, New Mexico
University of New Mexico Medical Center
Albuquerque, New Mexico, United States, 87131
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
Forsyth Medical Center
Winston-Salem, North Carolina, United States, 27103
United States, Pennsylvania
Temple University Hospital
Philadelphia, Pennsylvania, United States, 19140
United States, South Carolina
Greenville Hospital System
Greenville, South Carolina, United States, 29605
United States, Tennessee
University of Tennesse Medical Center
Knoxville, Tennessee, United States, 37920
United States, Texas
University of Texas Health Sciences Center at Houston
Houston, Texas, United States, 77030
Sponsors and Collaborators
Ferring Pharmaceuticals
Investigators
Study Director: Clinical Development Support Ferring Pharmaceuticals
  More Information

No publications provided by Ferring Pharmaceuticals

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Ferring Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00828711     History of Changes
Other Study ID Numbers: Miso-Obs-204
Study First Received: January 22, 2009
Results First Received: January 24, 2014
Last Updated: March 10, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Ferring Pharmaceuticals:
Misoprostol vaginal insert
Induction of labor
Cervical ripening
Rate of cesarean section

Additional relevant MeSH terms:
Misoprostol
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Anti-Ulcer Agents
Gastrointestinal Agents
Oxytocics

ClinicalTrials.gov processed this record on July 31, 2014