The US Food and Drug Administration (FDA) recently approved Estradiol Gel, 0.06%, for the treatment of moderate to severe hot flashes associated with menopause. This approval provides women experiencing menopause-related symptoms with a new option for hormone replacement therapy (HRT).

Estradiol is a form of estrogen, a hormone that naturally declines during menopause. The Estradiol Gel, 0.06% formulation delivers estrogen through the skin, allowing for a controlled and consistent release into the bloodstream. This topical gel is applied once daily to clean, dry skin, typically on the arms or thighs, and it is designed to help alleviate symptoms such as hot flashes, which are common in postmenopausal women. The gel also relieves symptoms of ovary removal and breast cancer and helps prevent osteoporosis.

This approval is for the generic version of EstroGel Gel, 0.06%, originally approved in February 2004.

The FDA’s approval of this gel marks a significant advancement for postmenopausal women who are looking for relief from the uncomfortable symptoms of menopause but may prefer not to use oral medications or other treatment options. Topical estradiol therapy provides the advantage of bypassing the digestive system, which can sometimes cause gastrointestinal side effects associated with oral treatments. The gel is easy to use and can be more conveniently incorporated into daily routines compared to some other hormone therapy methods.

The approval was based on data from clinical trials that demonstrated the gel’s ability to significantly reduce both the frequency and severity of hot flashes. In one key study, women who used 0.75 mg of Estradiol Gel reported a significant improvement in the frequency of hot flashes compared to those who were given a placebo. The gel’s safety profile was also assessed, revealing a manageable risk when used as directed.

In a study of 24 non-dosed healthy postmenopausal women, there was no measurable transfer of estradiol one hour after direct skin-to-skin contact with those using estradiol gel.

A study in Sexuality, Reproduction, and Menopause found that among 890 menopausal women using estradiol gel, hot flash frequency decreased by about 75%, from 5.87 to 1.44 per day. The severity of hot flashes and vaginal dryness improved by approximately 55% and 50%. Notably, 75% of participants reported improvements within two weeks, 89% by three weeks, and 95% by four weeks.

The most common side effects (“adverse events” or “AE” as the FDA calls them) include headache, flatulence, and breast pain or tenderness. Other AEs were reported with very low levels of occurrence.

This generic option offers a more affordable alternative for patients than the previous EstroGel.

With the approval of Estradiol Gel, 0.06%, women now have another treatment option for managing postmenopausal symptoms. As with any new medication, it will be important for healthcare professionals to continue monitoring long-term outcomes and for patients to remain informed about both the benefits and risks of hormone replacement therapy.

BONUS: Want a natural option to help limit hot flashes? Our brand new Meno-PRO is designed to do exactly that!

Sources:
https://www.globenewswire.com/en/news-release/2024/10/25/2969362/0/en/ANI-Pharmaceuticals-Announces-the-FDA-Approval-and-Launch-of-Estradiol-Gel-0-06.html
https://journals.lww.com/menopausejournal/abstract/2012/06000/transdermal_estradiol_gel_for_the_treatment_of.9.aspx
https://www.researchgate.net/publication/289311862
https://www.heart.org/en/health-topics/venous-thromboembolism/what-is-venous-thromboembolism-vte