Contraceptive Effectiveness and Safety Study of the SILCS Diaphragm: the Pivotal Study
Brief description: This multi-center contraceptive effectiveness and safety study of the SILCS diaphragm will enroll approximately 450 couples at risk for pregnancy at six study sites in the U.S. The study will randomly assign approximately 300 couples to use the SILCS diaphragm with BufferGel and approximately 150 couples to use the SILCS diaphragm with Gynol II (2% N-9 gel). At two sites, a substudy involving colposcopy and microflora will be conducted in about 80 women (40 at each site). The primary objective of this study is to estimate the cumulative 6-month typical-use pregnancy probability for women using the SILCS diaphragm with a contraceptive gel.
Detailed description: This multi-center contraceptive effectiveness and safety study of the SILCS diaphragm will enroll approximately 450 couples at risk for pregnancy w at six study sites in the U.S. The study will randomly assign approximately 300 couples to use the SILCS diaphragm with BufferGel (BG) and approximately 150 couples to use the SILCS diaphragm with Gynol II (2% N-9 gel). At two sites, a substudy involving colposcopy and microflora will be conducted in about 80 women (40 at each site). For certain evaluations, the data from a contraceptive study conducted by NICHD of the Ortho All-Flex diaphragm used with either BG or N-9 will be used as historical controls. In the current study, each participant will agree to use the SILCS diaphragm with her assigned contraceptive gel as her only method of contraception for approximately 7 months (at least 190 days) and at least 6 menstrual cycles. Emergency contraception will be offered if unprotected intercourse occurs, according to local prescribing practices. Each female participant will undergo four scheduled visits: Enrollment, After Cycle 1, After Cycle 3, and Final visits. Two weeks after enrollment, each participant will be called to determine if she has had any problems with the method and to assess compliance. Recruitment for this study is expected to take about 12 months. Each subject's participation will last about 6-7 months. Site closeout is expected to take three months. The clinical portion of the study should last about 21 months. Data closure and analysis are expected to take three months and the Final Report two additional months.
Detailed description: This multi-center contraceptive effectiveness and safety study of the SILCS diaphragm will enroll approximately 450 couples at risk for pregnancy w at six study sites in the U.S. The study will randomly assign approximately 300 couples to use the SILCS diaphragm with BufferGel (BG) and approximately 150 couples to use the SILCS diaphragm with Gynol II (2% N-9 gel). At two sites, a substudy involving colposcopy and microflora will be conducted in about 80 women (40 at each site). For certain evaluations, the data from a contraceptive study conducted by NICHD of the Ortho All-Flex diaphragm used with either BG or N-9 will be used as historical controls. In the current study, each participant will agree to use the SILCS diaphragm with her assigned contraceptive gel as her only method of contraception for approximately 7 months (at least 190 days) and at least 6 menstrual cycles. Emergency contraception will be offered if unprotected intercourse occurs, according to local prescribing practices. Each female participant will undergo four scheduled visits: Enrollment, After Cycle 1, After Cycle 3, and Final visits. Two weeks after enrollment, each participant will be called to determine if she has had any problems with the method and to assess compliance. Recruitment for this study is expected to take about 12 months. Each subject's participation will last about 6-7 months. Site closeout is expected to take three months. The clinical portion of the study should last about 21 months. Data closure and analysis are expected to take three months and the Final Report two additional months.