Contraceptive efficacy, acceptability, and safety of C31G and nonoxynol-9 spermicidal gels: A randomized controlled trial

Anne E. Burke, Kurt Barnhart, Jeffrey T. Jensen, Mitchell D. Creinin, Terri L. Walsh, Livia S. Wan, Carolyn Westhoff, Michael Thomas, David Archer, Hongsheng Wu, James Liu, William Schlaff, Bruce R. Carr, Diana Blithe

Research output: Contribution to journalArticle

19 Citations (Scopus)

Abstract

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.

Original languageEnglish (US)
Pages (from-to)1265-1273
Number of pages9
JournalObstetrics and Gynecology
Volume116
Issue number6
DOIs
StatePublished - Dec 2010

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Nonoxynol
Contraceptive Agents
Randomized Controlled Trials
Gels
Safety
Pregnancy
Confidence Intervals
Sample Size
C 31G
Coitus
Lost to Follow-Up
Pregnancy Rate
Contraception
Healthy Volunteers
Outcome Assessment (Health Care)

ASJC Scopus subject areas

  • Obstetrics and Gynecology

Cite this

Burke, A. E., Barnhart, K., Jensen, J. T., Creinin, M. D., Walsh, T. L., Wan, L. S., ... Blithe, D. (2010). Contraceptive efficacy, acceptability, and safety of C31G and nonoxynol-9 spermicidal gels: A randomized controlled trial. Obstetrics and Gynecology, 116(6), 1265-1273. https://doi.org/10.1097/AOG.0b013e3181fc3b1a

Contraceptive efficacy, acceptability, and safety of C31G and nonoxynol-9 spermicidal gels : A randomized controlled trial. / Burke, Anne E.; Barnhart, Kurt; Jensen, Jeffrey T.; Creinin, Mitchell D.; Walsh, Terri L.; Wan, Livia S.; Westhoff, Carolyn; Thomas, Michael; Archer, David; Wu, Hongsheng; Liu, James; Schlaff, William; Carr, Bruce R.; Blithe, Diana.

In: Obstetrics and Gynecology, Vol. 116, No. 6, 12.2010, p. 1265-1273.

Research output: Contribution to journalArticle

Burke, AE, Barnhart, K, Jensen, JT, Creinin, MD, Walsh, TL, Wan, LS, Westhoff, C, Thomas, M, Archer, D, Wu, H, Liu, J, Schlaff, W, Carr, BR & Blithe, D 2010, 'Contraceptive efficacy, acceptability, and safety of C31G and nonoxynol-9 spermicidal gels: A randomized controlled trial', Obstetrics and Gynecology, vol. 116, no. 6, pp. 1265-1273. https://doi.org/10.1097/AOG.0b013e3181fc3b1a
Burke, Anne E. ; Barnhart, Kurt ; Jensen, Jeffrey T. ; Creinin, Mitchell D. ; Walsh, Terri L. ; Wan, Livia S. ; Westhoff, Carolyn ; Thomas, Michael ; Archer, David ; Wu, Hongsheng ; Liu, James ; Schlaff, William ; Carr, Bruce R. ; Blithe, Diana. / Contraceptive efficacy, acceptability, and safety of C31G and nonoxynol-9 spermicidal gels : A randomized controlled trial. In: Obstetrics and Gynecology. 2010 ; Vol. 116, No. 6. pp. 1265-1273.
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abstract = "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.",
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T1 - Contraceptive efficacy, acceptability, and safety of C31G and nonoxynol-9 spermicidal gels

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AU - Burke, Anne E.

AU - Barnhart, Kurt

AU - Jensen, Jeffrey T.

AU - Creinin, Mitchell D.

AU - Walsh, Terri L.

AU - Wan, Livia S.

AU - Westhoff, Carolyn

AU - Thomas, Michael

AU - Archer, David

AU - Wu, Hongsheng

AU - Liu, James

AU - Schlaff, William

AU - Carr, Bruce R.

AU - Blithe, Diana

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