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Study of Pharmacology of 17-OHPC in Pregnancy

This study has been completed.
Sponsor:
Collaborators:
National Institutes of Health (NIH)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00409825
First received: December 8, 2006
Last updated: February 9, 2015
Last verified: February 2015
Results First Received: January 13, 2015  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Basic Science
Condition: Pregnancy
Interventions: Drug: 17-OHPC
Procedure: Blood Draws

  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
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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
AUC1 vs AUC2

AUC 1 done after 4 weekly 17-OHPC injections completed, between 20 6/7 to 24 6/7 weeks gestation. 10 cc blood drawn pre-5th injection. 10 cc blood drawn 12 hours post-dose and 7 consecutive days. 24-hour urine collected days 4-5 within 7 days post-injection.

AUC 2 done 31 0/7 to 34 6/7 or at 35 0/7 weeks. 10 cc blood drawn pre weekly injection, 12 hours post-dose, and 7 consecutive days. 24-hour urine collected between days 4-5 within 7 days post-injection.


Participant Flow:   Overall Study
    AUC1 vs AUC2
STARTED   61 
COMPLETED   61 
NOT COMPLETED   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
AUC1 vs AUC2

AUC 1 done after 4 weekly 17-OHPC injections completed, between 20 6/7 to 24 6/7 weeks gestation. 10 cc blood drawn pre-5th injection. 10 cc blood drawn 12 hours post-dose and 7 consecutive days. 24-hour urine collected days 4-5 within 7 days post-injection.

AUC 2 done 31 0/7 to 34 6/7 or at 35 0/7 weeks. 10 cc blood drawn pre weekly injection, 12 hours post-dose, and 7 consecutive days. 24-hour urine collected between days 4-5 within 7 days post-injection.


Baseline Measures
   AUC1 vs AUC2 
Overall Participants Analyzed 
[Units: Participants]
 61 
Age 
[Units: Years]
Mean (Standard Deviation)
 28.01  (5.9) 
Gender 
[Units: Participants]
 
Female   61 
Male   0 
Ethnicity (NIH/OMB) 
[Units: Participants]
 
Hispanic or Latino   16 
Not Hispanic or Latino   44 
Unknown or Not Reported   1 
Race (NIH/OMB) 
[Units: Participants]
 
American Indian or Alaska Native   0 
Asian   1 
Native Hawaiian or Other Pacific Islander   1 
Black or African American   18 
White   40 
More than one race   0 
Unknown or Not Reported   1 
Region of Enrollment 
[Units: Participants]
 
United States   61 


  Outcome Measures

1.  Primary:   Change in the Area Under the Concentration vs. Time Curve in the Second and Third Trimesters of Pregnancy.   [ Time Frame: Second and third trimesters of pregnancy ]


  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
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.


Results Point of Contact:  
Name/Title: Steve N. Caritis, MD
Organization: University of Pittsburgh
phone: 412-641-4874
e-mail: scaritis@mail.magee.edu


Publications:
ACOG News Release: Progesterone recommended in certain high risk pregnancies to help prevent preterm birth. October 31, 2003
Kiesling H, Elmquist A: Acta Endocrinol 28:502, 1958
Langecker J, Harwart A, Junkmann K: Arch exptl Pathol. Pharacol 225:309, 1955.
Endocrinology & human gestation. IN: Reproductive Endocrinology, p458. Edited by EY Adashi, Lippincott-Raven Publishers, Philadelphia, PA 1996.
Lye S: Personal communication
Reprotox Database. Hydroxyprogesterone 17-. Reprotox. org. March 1, 2003.
Florey K: Hydroxyprogesterone caproate. IN: Analytical profiles of drug substances. Vol 4. 208-224 Editors: Academic Press, NY, NY, 1975.


Responsible Party: University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00409825     History of Changes
Other Study ID Numbers: IRB #0603056
5U10HD047905-02 ( US NIH Grant/Contract Award Number )
Study First Received: December 8, 2006
Results First Received: January 13, 2015
Last Updated: February 9, 2015
Health Authority: United States: Food and Drug Administration