A Note About Compounded Products

Alloy believes that every woman deserves accurate, up-to-date information and the agency to make her own decisions about her health based on facts, not fear. All of our board-certified physicians follow ACOG and NAMS guidelines and prescribe only FDA-approved, generic medications for the treatment of menopausal symptoms, including hormone replacement therapy and vaginal estrogen cream. The safety of our products is our top priority.

Where there are FDA-approved options, we will always use those medications. On occasion, there are medications that we prescribe that are not FDA-approved, such as our ultra-low dose M4 Estriol based face cream and our O-mazing topical sildenafil cream. These products are compounded, a common practice where the ingredients are combined by a licensed pharmacy to create a new treatment. A compounded product is only as good as the compounding pharmacy, and to ensure the accuracy of dosing and purity of our compounded products, we have them batch-tested by an independent third party laboratory.

The active ingredient in our M4 face cream is estriol, a bioidentical estrogen that is produced in large quantities during pregnancy. It is a much weaker estrogen than estradiol and has been used in topical vaginal estrogen preparations in Europe for decades. Topical estriol has, like estradiol, been shown to markedly increase collagen and elastin production and reduce fine wrinkles and pore size. A review of studies using low dose topical estriol reveals that topical estriol does not increase the levels of estrogen in the bloodstream.

The active ingredient in O-mazing cream is sildenafil, or generic Viagra. Topical sildenafil increases blood flow to the vulva and clitoris at much lower doses than is required for an erection in men, and has been shown to increase both arousal and sensation. Viagra has been used safely in men for decades. Why it took so long for sildenafil to be studied in women remains a mystery.

The bottom line is this—we would love to have more FDA-approved options for menopausal and perimenopausal women. And remember--absence of proof is not always proof of absence. We need more research and innovations in women’s health care, and it is no longer acceptable to simply accept the status quo. We are actively campaigning to get the restrictive warnings on low dose and ultra-low dose estrogen products removed because multiple studies have failed to demonstrate an elevation of blood estrogen levels with their use. Until we resolve these issues, we at Alloy will always endeavor to provide products that are safe, effective, and backed by science.