Study of Pharmacology of 17-OHPC in Pregnancy

PHASE2CompletedINTERVENTIONAL
Enrollment

61

Participants

Timeline

Start Date

March 31, 2006

Primary Completion Date

April 30, 2008

Study Completion Date

February 28, 2014

Conditions
Pregnancy
Interventions
DRUG

17-OHPC

Intra-muscular injection of 250 mg 17-OHPC administered weekly between the second and third trimesters of pregnancy, until time of delivery.

PROCEDURE

Blood Draws

10 cc of blood will be drawn prior to the fifth weekly administration of 17-OHPC during second trimester of pregnancy, and then once daily for seven consecutive days post-dose. 10 cc of blood also will be drawn prior to weekly administration of 17-OHPC from sixth weekly dose in the second trimester until the last scheduled dose in the third trimester. Prior to this last scheduled dose, 10 cc of blood will be drawn, as well as once daily for seven consecutive days post-dose.

Trial Locations (4)

15213

Magee-Womens Hospital of University of Pittsburgh Medical Center, Pittsburgh

20010

Georgetown University, Washington D.C.

77555

University of Texas, Galveston

98195

University of Washington, Seattle

All Listed Sponsors
collaborator

National Institutes of Health (NIH)

NIH

collaborator

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

lead

University of Pittsburgh

OTHER

NCT00409825 - Study of Pharmacology of 17-OHPC in Pregnancy | Biotech Hunter | Biotech Hunter