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Cellulose sulfate: tolerance and acceptability of penile application
C Mauck1, R Frezieres, T Walsh
1CONRAD Program, Arlington, VA, USA. cmauck@conrad.org
Contraception
|February 9, 2002
Summary
Sodium cellulose sulfate (CS) gel shows comparable safety and acceptability to nonoxynol-9 for male genital use. This microbicide candidate appears suitable for further clinical trials in couples for vaginal intercourse.
Area of Science:
- Reproductive Health
- Dermatology
- Pharmacology
Background:
- Sodium cellulose sulfate (CS) is being developed as a potential vaginal microbicide and spermicide.
- Assessing the safety and acceptability of new microbicide candidates in both male and female populations is crucial for their development.
Purpose of the Study:
- To evaluate the acceptability, safety, and penile irritation of daily doses of sodium cellulose sulfate (CS) gel in men.
- To compare CS gel's safety profile against an active control, nonoxynol-9 (Conceptrol).
Main Methods:
- A Phase I, randomized, double-blind study was conducted.
- Male volunteers received seven consecutive daily doses of CS gel or Conceptrol.
- Penile irritation and acceptability were assessed.
Main Results:
- Sodium cellulose sulfate (CS) gel demonstrated no increased penile irritation compared to the nonoxynol-9 (Conceptrol) control.
- Minimal irritation was observed in a prior Phase I study of CS in women.
- Mild, transient symptoms like tingling and stinging were reported by a small number of participants in both groups.
Conclusions:
- Sodium cellulose sulfate (CS) gel appears safe and acceptable for male genital use.
- The findings support the potential use of CS in future clinical studies involving couples.
- Further research can proceed without undue risk, considering the observed safety profile.
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