OBJECTIVE: To estimate whether a gel containing the spermicide C31G was noninferior to a commercially available product containing nonoxynol-9. METHODS:Participants were healthy, sexually active women aged 18-40 years. Measured outcomes included pregnancy rates, continuation rates, adverse events, and acceptability. The primary study outcome was contraceptive efficacy. Sample size was calculated at a 2.5% significance level using a one-sided test based on assumed 6-month pregnancy probability of 15% in the nonoxynol-9 group. Sample size was sufficient to reject, with 80% power, the null hypothesis that pregnancy probability in the C31G arm would be more than 5% higher. RESULTS:Nine hundred thirty-two women were randomized in the C31G group and 633 in the nonoxynol-9 group. For randomized patients with at least one episode of coitus (modified intent-to-treat group), 6-month pregnancy probabilities were 12.0% (95% confidence interval [CI] 9.3-14.7%) and 12.0% (95% CI 8.7-15.3%) for C31G and nonoxynol-9,respectively. Twelve-month pregnancy probabilities were 13.8% (95% CI 7.6-20%) for C31G and 19.8% (95% CI 10.9-28.7%) for nonoxynol-9. Two serious adverse events were deemed possibly related to study product and neither occurred in the C31G group. Three fourths of users in either group reported that they liked their assigned study product. Approximately 40% of patients discontinued prematurely for reasons other than pregnancy with 11% lost to follow-up. CONCLUSION: C31G demonstrated noninferior contraceptive efficacy compared with nonoxynol-9. C31G may provide another marketable option for women seeking spermicidal contraception. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, www.ClinicalTrials.gov, NCT00274261.
RCT Entities:
OBJECTIVE: To estimate whether a gel containing the spermicide C31G was noninferior to a commercially available product containing nonoxynol-9. METHODS:Participants were healthy, sexually active women aged 18-40 years. Measured outcomes included pregnancy rates, continuation rates, adverse events, and acceptability. The primary study outcome was contraceptive efficacy. Sample size was calculated at a 2.5% significance level using a one-sided test based on assumed 6-month pregnancy probability of 15% in the nonoxynol-9 group. Sample size was sufficient to reject, with 80% power, the null hypothesis that pregnancy probability in the C31G arm would be more than 5% higher. RESULTS: Nine hundred thirty-two women were randomized in the C31G group and 633 in the nonoxynol-9 group. For randomized patients with at least one episode of coitus (modified intent-to-treat group), 6-month pregnancy probabilities were 12.0% (95% confidence interval [CI] 9.3-14.7%) and 12.0% (95% CI 8.7-15.3%) for C31G and nonoxynol-9,respectively. Twelve-month pregnancy probabilities were 13.8% (95% CI 7.6-20%) for C31G and 19.8% (95% CI 10.9-28.7%) for nonoxynol-9. Two serious adverse events were deemed possibly related to study product and neither occurred in the C31G group. Three fourths of users in either group reported that they liked their assigned study product. Approximately 40% of patients discontinued prematurely for reasons other than pregnancy with 11% lost to follow-up. CONCLUSION:C31G demonstrated noninferior contraceptive efficacy compared with nonoxynol-9. C31G may provide another marketable option for women seeking spermicidal contraception. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, www.ClinicalTrials.gov, NCT00274261.
Authors: Bradley J Catalone; Shendra R Miller; Mary Lee Ferguson; Dan Malamud; Tina Kish-Catalone; Nina J Thakkar; Fred C Krebs; Mary K Howett; Brian Wigdahl Journal: Biomed Pharmacother Date: 2005-09 Impact factor: 6.529
Authors: Kurt T Barnhart; Michael J Rosenberg; H Trent MacKay; Diana L Blithe; Jim Higgins; Terri Walsh; Livia Wan; Michael Thomas; Mitchell D Creinin; Carolyn Westhoff; William Schlaff; David F Archer; Charletta Ayers; Andrew Kaunitz; Sutapa Das; Thomas R Moench Journal: Obstet Gynecol Date: 2007-09 Impact factor: 7.661
Authors: Christine K Mauck; Ron G Freziers; Terri L Walsh; Karen Peacock; Jill L Schwartz; Marianne M Callahan Journal: Obstet Gynecol Date: 2008-03 Impact factor: 7.661
Authors: James M Hill; Ethan M Stern; Partha S Bhattacharjee; Daniel Malamud; Christian Clement; Paulo Rodriguez; Walter J Lukiw; Augusto C Ochoa; Timothy P Foster; Cruz Velasco; Harris E McFerrin Journal: Antiviral Res Date: 2013-07-13 Impact factor: 5.970
Authors: Bhawana Shrestha; Alison Schaefer; Yong Zhu; Jamal Saada; Timothy M Jacobs; Elizabeth C Chavez; Stuart S Olmsted; Carlos A Cruz-Teran; Gabriela Baldeon Vaca; Kathleen Vincent; Thomas R Moench; Samuel K Lai Journal: Sci Transl Med Date: 2021-08-11 Impact factor: 17.956
Authors: Bhawana Shrestha; Kathleen Vincent; Alison Schaefer; Yong Zhu; Gracie Vargas; Massoud Motamedi; Kelsi Swope; Josh Morton; Carrie Simpson; Henry Pham; Miles B Brennan; Michael H Pauly; Larry Zeitlin; Barry Bratcher; Kevin J Whaley; Thomas R Moench; Samuel K Lai Journal: Proc Natl Acad Sci U S A Date: 2021-11-30 Impact factor: 11.205