EFFICACY TRIAL OF SPERMICIDAL AGENTS NIH GUIDE, Volume 25, Number 18, June 7, 1996 RFP AVAILABLE: NICHD-CRE-96-09 P.T. 34 Keywords: Contraceptives Human Reproduction/Fertility National Institute of Child Health and Human Development The Contraceptive and Reproductive Evaluation Branch of the Center for Population Research, National Institute of Child Health and Human Development (NICHD), requires information on the contraceptive efficacy of different spermicide formulations marketed in the U.S. Secondary objectives include measurement of safety (adverse reactions) and acceptability. A clinical trial is requested that will rely on an educational/motivational component to maximize the number of consistent and correct users of spermicides during the trial period. The NICHD is seeking organization(s) capable of designing and conducting an observational study among women of reproductive age, obtaining reproductive histories, training subject in coital log use, and perform clinical testing to ascertain chemical pregnancies. Offerors should have knowledge of reproduction and contraception, expertise in the conduct of large clinical trials, and experience in analysis of large research data sets. Emphasis will be placed in the ability of the Offeror to recruit and follow adequate numbers of subjects during the course of the study. The Government estimates the total required effort to be approximately 17.1 staff years to complete a six-month follow-up of at least 300 women in each of four observational arms over a performance period of four years. It is estimated that from one to four cost-reimbursement, incrementally funded contract will be awarded. INQUIRIES This announcement is not a Request for Proposals (RFP). RFP NICHD-CRE-96-09 will be issued on or about June 10, 1996, and proposals will be due 90 days thereafter. Copies of the RFP may be obtained by FAX request or by sending a written request, along with a self-addressed mailing label to: Charles W. Grewe Contracts Management Branch National Institute of Child Health and Human Development 6100 Executive Boulevard, Suite 7A07 Bethesda, MD 20892-7510 FAX: (301) 402-3676 .
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