Red Clover Isoflavones Help Vaginal Dryness in Women at Midlife

Newswise — Results of a prospective, double-blind, placebo- controlled trial presented Saturday in London at the British Menopause Society Annual Meeting indicate that Novogen's red clover isoflavone supplement (Promensil) is a natural alternative for minimizing vaginal dryness in healthy, postmenopausal women.

As women get older, the vagina becomes dry and overly delicate in response to declining levels of the female hormone estrogen. About one in two postmenopausal women experience vaginal dryness and sensitivity.1 A normal part of aging, the dryness can be managed to help women avoid everyday discomfort and continue to enjoy sex.

The research -- led by Dr. Malcolm Whitehead, Director, Gynecology/Endocrinology Unit, King's College Hospital, London -- found that 80 mg of Promensil significantly improved the vaginal maturation index (VMI), a measure of normal functioning of the epithelium lining the vagina, compared to placebo, while there was no increase seen in endometrial thickening for either the Promensil or placebo groups.

"The preliminary results of this study are encouraging news for women who want to manage menopause naturally and to continue enjoying sex," said Dr. Whitehead. "Unlike steroidal estrogens, the natural isoflavone phytoestrogens or plant estrogens provided by the red clover supplement are showing a welcome estrogenic effect in relieving vaginal dryness while showing no adverse thickening effect on the endometrium."

This study complements two further randomized placebo-controlled studies published last year demonstrating that the daily use of Promensil significantly decreases hot flashes in postmenopausal women.2,3

Promensil is a natural dietary isoflavone supplement derived from red clover for women during and after menopause. Standardized to pharmaceutical grade Good Manufacturing Practice (GMP) levels, it is a rich source of the four major dietary isoflavones known to be bioactive. Promensil has been studied more extensively and rigorously than any other similar dietary supplement, including those based on soy, which contains only two out of the four isoflavones found in red clover.

The aim of the King's College Hospital study was to evaluate the efficacy and safety of Promensil versus placebo on endometrial thickening, uterine blood flow and the vaginal maturation index. A prospective, randomized, double blind, placebo-controlled, cross-over trial with two 8-week phases was conducted. Twenty-nine women, age 45-65, received either 80mg of Promensil daily or placebo for the first active phase of eight weeks, followed by a 2-week 'wash-out' on placebo and an additional eight weeks on the reverse treatment. No adverse side effects were reported during the study.

Novogen Limited (Nasdaq: NVGN) is a pharmaceutical company based in Sydney, Australia with offices in Stamford, Connecticut. Novogen is involved in the development of isoflavone supplements and drug discovery for disorders that are commonly associated with aging. Over the past five years, Novogen has conducted the largest and most comprehensive isoflavone clinical testing program in the world. Current products include Promensilä, Rimostil™ and Trinovin™ -- a midlife health range of natural products, scientifically developed for menopause, post-menopause and prostate health. Novogen is also researching and developing compounds for the treatment of cancer, cardiovascular disease and inflammatory bowel disease. More information can be found at www.novogen.com.

References1 Atrophic vaginitis leaflet. Prodigy, NHS. November 2002.2 Van de Weijer PHM, Barentsen R. Isoflavones from red clover (Promensil) significantly reduce hot flashes compared with placebo. Maturitas 2002; 42: 187-1933 Jeri AR. The effect of isoflavone phytoestrogens in relieving hot flushes in Peruvian postmenopausal women. The Female Patient 2002; 27: 35