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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