EFFICACY OF CIDR-Gs SYNCHRONIZATION OF ESTRUS IN GOATS ADR: 324 GCP Study No. 07-324-EFF INAD I-011389PROJECT SUMMARYThe specific objectives of this study are to evaluate the ability of Controlled Internal Drug Releasedevices (CIDR-G intravaginal implants) to synchronize estrus in goats and to compare the reproductivesafety in treated goats to that in untreated goats. CIDR-G's contain a low concentration of progesteroneincorporated into a slow-release elastomer. The progesterone is released over a period of 17 to 19 days.When the CIDR-G device is removed, the females usually come into estrus within 24 to 48 hours and canbe bred at that time. The goal of this project is to provide efficacy data to support the approval forsynchronization of estrus in both meat-type and lactating dairy goats. The protocol has been approved bythe FDA/CVM and CIDR-G's are designated. This is the last remaining study necessary for supportingthe approval of CIDR-G's in goats. We will determine efficacy and reproductive safety in at least twodifferent geographic areas of the U.S. in approximately 6 meat goat herds and 6 dairy goat herds ofapproximately 60 does each. Approximately 400 goats of each type will need to be enrolled in the study.In the fall and winter of 2009-2010 we conducted initial studies in Iowa (one herd of meat-type goats) andCalifornia (a small herd of dairy goats). CIDR's proved to be very effective at synchronization of estrusand all indications are that reproductive safety of the implants is not an issue. Our plan is to enrollsufficient numbers of goats in the 2010 fall breeding season to complete the required studies. We have anumber of meat- and dairy goat producers in several states that are interested in working with us tocomplete these studies. The goal is to have a study report submitted to the FDA/CVM Office of NewAnimal Drug Evaluation in 2011.

Public Health Relevance

The purpose of this research is to evaluate the efficacy and reproductive safety of Controlled Internal Release Devices (CIDR-G) when used to synchronize the estrus cycle of goats. This is the last study required to support the approval of CIDR-G's for use in goats. 1

Agency
National Institute of Health (NIH)
Institute
Food and Drug Administration (FDA)
Type
Research Project (R01)
Project #
1R01FD004000-01
Application #
8074318
Study Section
Special Emphasis Panel (ZFD1-OPD-N (02))
Project Start
2010-09-15
Project End
2011-09-14
Budget Start
2010-09-15
Budget End
2011-09-14
Support Year
1
Fiscal Year
2010
Total Cost
Indirect Cost
Name
Iowa State University
Department
Veterinary Sciences
Type
Schools of Veterinary Medicine
DUNS #
005309844
City
Ames
State
IA
Country
United States
Zip Code
50011