The launch in 2022 of Gina 10 micrograms vaginal tablets containing estradiol hemihydrate was the first OTC hormone product delivered intravaginally for vaginal atrophy. Specifically, it is indicated for the treatment of vaginal atrophy due to oestrogen deficiency in postmenopausal women aged 50 years and above, who have not had a period for at least 1 year.³⁸

In its consultation on switching the drug from prescription only (POM) to pharmacy (P) medicine status, the medicines regulator, the MHRA, said that “although it is not known if Gina can be safely used in women who had breast cancer in the past, recent evidence suggests that using Gina does not increase the risk of breast cancer in women who had no breast cancer in the past.”³⁹

In addition, “the risk of oestrogen-dependent malignancies occurring (endometrial and ovarian cancers) is considered to be extremely low and is similar to the number of postmenopausal women reporting these cancers who have not used a low dose vaginal oestrogen.”

Under the market authorisation, the product is contraindicated with a range of conditions, including if the woman has or has ever had breast cancer or has experienced blood clotting/thromboses or cardiovascular conditions including heart attack, stroke or angina.³⁸