A randomized Phase I vaginal safety study of three concentrations of C31G vs. Extra Strength Gynol II

Christine K. Mauck, Debra H. Weiner, Mitchell D Creinin, Kurt T. Barnhart, Marianne M. Callahan, Richard Bax

Research output: Contribution to journalArticle

44 Citations (Scopus)

Abstract

Background C31G is an antimicrobial and spermicidal agent that contains two surface-active compounds, cetyl betaine and myristamine oxide. It is being developed as a vaginal microbicide and contraceptive. Method Three C31G concentrations (0.5%, 1.0% and 1.7%) were tested and compared with Extra Strength Gynol II®, a marketed spermicide containing 3% nonoxynol-9 (N-9), in a randomized, double-blinded, Phase I, dose-escalation study to assess genital irritation (by subject report, visual examination at pelvic examination and colposcopy), plasma and vaginal lavage levels of C31G, product leakage, systemic safety and acceptability. Women were randomized to use 3.5 mL of one of the three C31G products or the N-9 gel at night for 7 days then twice daily for another 7 days. Pelvic and colposcopic evaluations were performed after 7 and 14 days of product use. Results The percent of women experiencing irritation in the 0.5% and 1.0% C31G groups in the study were similar to each other and were lower than the percent experiencing irritation in the 1.7% and N-9 groups, which were also similar to each other. Differences were statistically significant between 1.0% C31G vs. N-9 at 7 days and between 0.5% C31G and 1.0% C31G vs. N-9 at 14 days. There was no significant difference between groups in leakage or acceptability. No C31G was detected in the plasma of any volunteer. Conclusions These results suggest that 0.5% and 1.0% C31G are less irritating to the female genital tract than 1.7% C31G or Extra Strength Gynol II.

Original languageEnglish (US)
Pages (from-to)233-240
Number of pages8
JournalContraception
Volume70
Issue number3
DOIs
StatePublished - Sep 2004
Externally publishedYes

Fingerprint

Safety
Anti-Infective Agents
Spermatocidal Agents
C 31G
Vaginal Douching
Nonoxynol
Betaine
Gynecological Examination
Colposcopy
Contraceptive Agents
Oxides
Volunteers
Gels

Keywords

  • Cervix
  • Contraception
  • Genital irritation
  • Microbicide
  • Phase I clinical trial
  • Spermicide
  • Vagina

ASJC Scopus subject areas

  • Medicine(all)
  • Obstetrics and Gynecology

Cite this

A randomized Phase I vaginal safety study of three concentrations of C31G vs. Extra Strength Gynol II. / Mauck, Christine K.; Weiner, Debra H.; Creinin, Mitchell D; Barnhart, Kurt T.; Callahan, Marianne M.; Bax, Richard.

In: Contraception, Vol. 70, No. 3, 09.2004, p. 233-240.

Research output: Contribution to journalArticle

Mauck, Christine K. ; Weiner, Debra H. ; Creinin, Mitchell D ; Barnhart, Kurt T. ; Callahan, Marianne M. ; Bax, Richard. / A randomized Phase I vaginal safety study of three concentrations of C31G vs. Extra Strength Gynol II. In: Contraception. 2004 ; Vol. 70, No. 3. pp. 233-240.
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T1 - A randomized Phase I vaginal safety study of three concentrations of C31G vs. Extra Strength Gynol II

AU - Mauck, Christine K.

AU - Weiner, Debra H.

AU - Creinin, Mitchell D

AU - Barnhart, Kurt T.

AU - Callahan, Marianne M.

AU - Bax, Richard

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N2 - Background C31G is an antimicrobial and spermicidal agent that contains two surface-active compounds, cetyl betaine and myristamine oxide. It is being developed as a vaginal microbicide and contraceptive. Method Three C31G concentrations (0.5%, 1.0% and 1.7%) were tested and compared with Extra Strength Gynol II®, a marketed spermicide containing 3% nonoxynol-9 (N-9), in a randomized, double-blinded, Phase I, dose-escalation study to assess genital irritation (by subject report, visual examination at pelvic examination and colposcopy), plasma and vaginal lavage levels of C31G, product leakage, systemic safety and acceptability. Women were randomized to use 3.5 mL of one of the three C31G products or the N-9 gel at night for 7 days then twice daily for another 7 days. Pelvic and colposcopic evaluations were performed after 7 and 14 days of product use. Results The percent of women experiencing irritation in the 0.5% and 1.0% C31G groups in the study were similar to each other and were lower than the percent experiencing irritation in the 1.7% and N-9 groups, which were also similar to each other. Differences were statistically significant between 1.0% C31G vs. N-9 at 7 days and between 0.5% C31G and 1.0% C31G vs. N-9 at 14 days. There was no significant difference between groups in leakage or acceptability. No C31G was detected in the plasma of any volunteer. Conclusions These results suggest that 0.5% and 1.0% C31G are less irritating to the female genital tract than 1.7% C31G or Extra Strength Gynol II.

AB - Background C31G is an antimicrobial and spermicidal agent that contains two surface-active compounds, cetyl betaine and myristamine oxide. It is being developed as a vaginal microbicide and contraceptive. Method Three C31G concentrations (0.5%, 1.0% and 1.7%) were tested and compared with Extra Strength Gynol II®, a marketed spermicide containing 3% nonoxynol-9 (N-9), in a randomized, double-blinded, Phase I, dose-escalation study to assess genital irritation (by subject report, visual examination at pelvic examination and colposcopy), plasma and vaginal lavage levels of C31G, product leakage, systemic safety and acceptability. Women were randomized to use 3.5 mL of one of the three C31G products or the N-9 gel at night for 7 days then twice daily for another 7 days. Pelvic and colposcopic evaluations were performed after 7 and 14 days of product use. Results The percent of women experiencing irritation in the 0.5% and 1.0% C31G groups in the study were similar to each other and were lower than the percent experiencing irritation in the 1.7% and N-9 groups, which were also similar to each other. Differences were statistically significant between 1.0% C31G vs. N-9 at 7 days and between 0.5% C31G and 1.0% C31G vs. N-9 at 14 days. There was no significant difference between groups in leakage or acceptability. No C31G was detected in the plasma of any volunteer. Conclusions These results suggest that 0.5% and 1.0% C31G are less irritating to the female genital tract than 1.7% C31G or Extra Strength Gynol II.

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KW - Contraception

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KW - Microbicide

KW - Phase I clinical trial

KW - Spermicide

KW - Vagina

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