The proposed study is an industry sponsored investigation which compares the efficacy of their gonadotropin product (Repronex) given either IM or SC to that of """"""""gold standard"""""""" Pergonal given IM. The two major hypotheses of the study is that Repronex has the same effectiveness as Pergonal and that Repronex given SC is just as efficacious as Repronex given IM. Currently, several gonadotropin products have been approved by the FDA for the treatment of women for ovulation induction or controlled ovarian hyperstimulation. These products include both Repronex and Pergonal. However, head to head studies of these medications have not been performed. In addition, standard gonadotropin preparations require IM injections which is both painful and usually requires the presence of a second person to aid with the daily injections. Some newer, more expensive preparations have been developed that can be given SC although it seems that these products don't always have a similar response to the standard gonadotropin (Pergonal). Should Repronex work just as well as Pergonal whether given IM or SC, the benefits to the patient inlude: decreased cost and increased ease of administration. At this time there are no plans to followup on this study. Since a total of 48 patients will be randomized in several centers throughout the country, it is believed that this will provide adequate numbers to determine whether or not a difference exists.

Project Start
1998-12-01
Project End
1999-11-30
Budget Start
1998-10-01
Budget End
1999-09-30
Support Year
39
Fiscal Year
1999
Total Cost
Indirect Cost
Name
University of Alabama Birmingham
Department
Type
DUNS #
004514360
City
Birmingham
State
AL
Country
United States
Zip Code
35294
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