Contraceptive efficacy and safety of HerbOshield™ vaginal gel in rats.

BACKGROUND

Spermicides represent one of the methods of contraception. The synthetic agents available as spermicides produce severe side effects. Hence, there is a need to replace these agents with safe and effective agents such as plant-based contraceptive agents.

STUDY DESIGN

The objective of the present study was to develop and evaluate a stable, safe, effective and easily acceptable contraceptive delivery system containing herbal drug. Efforts were made to evaluate the contraceptive potential of the hydroalcoholic extract from the seeds of Annona squamosa Linn. and the vaginal gel HerbOshield™ containing the extract.

RESULTS

Spermicidal effect was evaluated in vitro using healthy human spermatozoa and in vivo in rats. The in vitro results demonstrated that HerbOshield™ vaginal gel is an effective spermicide. At a 100-mg/mL dose, complete immobilization of human spermatozoa was observed within 20 s. None of the treated animals conceived, indicating 100% contraceptive effect as compared to Gynol II, a nonoxynol-9-containing marketed formulation, which showed only 67% contraceptive effect in vivo. HerbOshield™ vaginal gel was found to be safe in animals during a 14-day toxicity study.

CONCLUSIONS

HerbOshield™ vaginal gel was found to be safe and effective in rats and could be developed as a potential vaginal contraceptive for future use in humans.