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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
Results First Received: January 24, 2014  
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
Conditions: Cervical Ripening
Induction of Labor
Interventions: Drug: MVI 100
Drug: MVI 150
Drug: MVI 200

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Pregnant women who required to be induced were recruited at 11 sites in the US

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
MVI 100

MVI 100 mcg vaginal insert

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.

MVI 150

MVI 150 mcg vaginal insert

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.

MVI 200

MVI 200 mcg vaginal insert

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.


Participant Flow:   Overall Study
    MVI 100     MVI 150     MVI 200  
STARTED     118     125     131  
COMPLETED     117     125     131  
NOT COMPLETED     1     0     0  
Lost to Follow-up                 1                 0                 0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
MVI 100

MVI 100 mcg vaginal insert

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.

MVI 150

MVI 150 mcg vaginal insert

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.

MVI 200

MVI 200 mcg vaginal insert

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.

Total Total of all reporting groups

Baseline Measures
    MVI 100     MVI 150     MVI 200     Total  
Number of Participants  
[units: participants]
  117     125     131     373  
Age  
[units: participants]
       
<=18 years     0     0     0     0  
Between 18 and 65 years     117     125     131     373  
>=65 years     0     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  26.0  ± 6.24     25.8  ± 5.92     25.5  ± 5.93     25.8  ± 6.01  
Gender  
[units: participants]
       
Female     117     125     131     373  
Male     0     0     0     0  
Region of Enrollment  
[units: participants]
       
United States     117     125     131     373  



  Outcome Measures
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1.  Primary:   Proportion of Women Delivering Vaginally   [ Time Frame: Interval from study drug administration to 24 hours ]

2.  Secondary:   Time to Vaginal Delivery   [ Time Frame: Interval from study drug administration to delivery (average 24 hours) ]

3.  Secondary:   Rate of Adverse Events   [ Time Frame: From study drug administration to hospital discharge (approximately 48 - 72 hours) ]

4.  Secondary:   Proportion of Cesarean Delivery   [ Time Frame: Interval from study drug administration to cesarean delivery (average 24 hours) ]

5.  Secondary:   Cervical Ripening Using Composite Measure of Success   [ Time Frame: 12 hours after insertion of drug ]

6.  Secondary:   Use of Oxytocin   [ Time Frame: At least 30 minutes after study drug removal ]

7.  Secondary:   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 ]

8.  Secondary:   Time to Onset of Active Labor   [ Time Frame: Interval from study drug administration to active labor (average 12 hours) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
None.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Clinical Development Support
Organization: Ferring Pharmaceuticals
e-mail: DK0-Disclosure@ferring.com


No publications provided by Ferring Pharmaceuticals

Publications automatically indexed to this study:

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