Zestra Laboratories announced primary results for its large-scale clinical study examining the potential of its widely available, non-hormonal, non-prescription Zestra(R) Feminine Arousal Fluid for improving the sexual experiences of women. This multi-center study, designed and managed by David M. Ferguson, PhD, MD, FACCP, is a randomized, placebo-controlled, double-blind, parallel design trial intended to expand on the results of the Phase 2 type study conducted in 2001. Efficacy assessments included the widely used, validated subject self-assessment questionnaire, the Female Sexual Function Index (FSFI). This Phase 3-type study evaluated the efficacy and safety of Zestra(R) compared to placebo oil in approximately 200 women diagnosed with acquired mixed interest/ desire/ arousal/ orgasm disorders in conditions of home use in conjunction with sexual activities.
Of the 296 women screened at 13 research sites, 256 were randomized to Zestra(R) or placebo. A total of 178 completed the entire study. There were no serious adverse events (SAEs) associated with study participants' use of Zestra(R) or placebo oil. Dr. Ferguson said, "The safety profile seen in this study reconfirms that of the earlier published study: Zestra(R) was well tolerated."
Analysis of the FSFI questionnaires indicated that Zestra(R) provided a significant benefit over placebo in the desire and satisfaction domains (P < 0.05), while showing a highly significant (P < 0.005) benefit over placebo in the arousal domain. Additionally, the total FSFI score showed a significant improvement over placebo (P < 0.05). These results confirm the arousal and satisfaction benefits seen in the previous published clinical trial of Zestra(R). The new, and unexpected result, is the significant benefit in the desire domain. All of these results can be interpreted as showing that Zestra(R) is well tolerated and provides desire, arousal, and sexual satisfaction benefits for a broad, generalized group of women with sexual difficulties.
"Although the Food and Drug Administration does not require clinical trials of non-prescription consumer products, Zestra Laboratories elected to conduct a Phase III-type FDA-quality study to further assess the product's safety and effectiveness," said Martin Crosby, Zestra's developer. "Our collaboration with the nation's leading medical and sexual health experts and our commitment to research demonstrate our intent to advance the science of female sexual health and provide a meaningful and safe solution for women today." Despite a decade of prescription pharmaceutical research in female sexual disorders, and several effective prescription treatments for erectile dysfunction (ED), there is still no FDA-approved drug treatment for any form of female sexual dysfunction or disorder.
"Results from the Zestra(R) study will provide important direction for future studies in women's sexual health," said Dr. Ferguson. "Because the study has only just concluded, there is a significant amount of additional valuable information in the database that we will analyze in great detail over the coming months," he said.