This contract provides for a multiple-arm randomized clinical trial of 1,200 women using four formulations of marketed nonoxynol-9 spermicides for the prevention of pregnancy. The study will determine the probability of pregnancy among women exposed to an intensive educational and motivational intervention designed to promote consistent and correct use of the spermicide. Secondary endpoint:s of interest include the incidence of adverse side-effects, and the acceptability of the four formulations.

Project Start
1997-09-01
Project End
2001-08-31
Budget Start
2000-08-01
Budget End
2001-01-31
Support Year
Fiscal Year
2000
Total Cost
$801,695
Indirect Cost
Name
Family Health International
Department
Type
DUNS #
067180786
City
Research Triangle Park
State
NC
Country
United States
Zip Code
27713
Harwood, Bryna; Meyn, Leslie A; Ballagh, Susan A et al. (2008) Cervicovaginal colposcopic lesions associated with 5 nonoxynol-9 vaginal spermicide formulations. Am J Obstet Gynecol 198:32.e1-7
Halpern, Vera; Rountree, Wes; Raymond, Elizabeth G et al. (2008) The effects of spermicides containing nonoxynol-9 on cervical cytology. Contraception 77:191-4
Schreiber, Courtney A; Meyn, Leslie A; Creinin, Mitchell D et al. (2006) Effects of long-term use of nonoxynol-9 on vaginal flora. Obstet Gynecol 107:136-43
Raymond, Elizabeth G; Chen, Pai Lien; Condon, Sean et al. (2005) Acceptability of five nonoxynol-9 spermicides. Contraception 71:438-42
Chen, Pai-Lien; Dominik, Rosalie (2004) Monitoring a three-armed clinical trial with survival endpoints: Fisher's least significant difference approach. J Biopharm Stat 14:791-801
Raymond, Elizabeth G; Chen, Pai Lien; Pierre-Louis, Bosny et al. (2004) Participant characteristics associated with withdrawal from a large randomized trial of spermicide effectiveness. BMC Med Res Methodol 4:23
Raymond, Elizabeth G; Chen, Pai Lien; Luoto, Joanne et al. (2004) Contraceptive effectiveness and safety of five nonoxynol-9 spermicides: a randomized trial. Obstet Gynecol 103:430-9