A clinical trial of the drug is now underway at UNSW’s School of Women’s and Children’s Health. The trial will evaluate the drug’s impact on hot flushes and quality of life, based on the experience of more than 160 women now being recruited in Sydney, Melbourne and Adelaide.
“The drug appears to have some impact on the hot flushes and night sweats usually associated with menopause, and a good trial outcome could lead to an alternative to hormone therapy without the side effects,” said trial leader Associate Professor John Eden.
Hot flushes were cited as the main reason menopausal women sought consultations with their doctor, according to a recent Gallup poll. Many women take treatment for symptom relief.
The drug being studied is synthetic S-equol, an active compound found in some people who consume soy products.
“S-equol can be produced naturally from an isoflavone present in soy in the intestine of certain individuals who have the appropriate anaerobic bacteria,” said Associate Professor Eden. “In Japan and China up to 80 percent of individuals are equol producers, compared to only one in four westerners.”
A pharmaceutical company has successfully completed two Phase 1 safety clinical trials for the drug and has reported a favourable safety profile.
To be eligible to take part, women need to experience hot flushes and night sweats and meet a number of other entry criteria. The study runs for 14 weeks and includes 6–7 visits to the clinic. Treatment is given for 4 weeks.
Women who would like to take part in the trial can call 02 9382 6621 to determine eligibility.