New Options for Treating Genital Atrophy

Andrew M. Kaunitz, MD


December 29, 2016

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Hello. I'm Andrew Kaunitz, professor and associate chairman of the Department of Obstetrics and Gynecology at the University of Florida College of Medicine in Jacksonville. Today I'd like to discuss treatment of genital atrophy in menopausal women.

In November 2016, the US Food and Drug Administration (FDA) approved vaginal dehydroepiandrosterone, also known as DHEA or prasterone and marketed as Intrarosa™, for menopausal women experiencing pain with sexual intercourse due to genital atrophy, a condition that is also known as genitourinary syndrome of menopause.[1] In clinical trials, vaginal ovules of DHEA were found to be effective in reducing symptoms of atrophy.[2] Vaginal discharge was the most common adverse effect. After menopause, DHEA, which is produced largely by the adrenals, is the main source of sex steroids. DHEA is enzymatically transformed at the intracellular level into estrogen, which is then inactivated locally. Accordingly, use of vaginal DHEA causes little, if any, rise in serum estradiol levels.[3]

These characteristics will likely make vaginal DHEA an attractive option for treating menopausal women with genital atrophy and perhaps also breast cancer survivors. Although package labeling for vaginal prasterone does not list a history of breast cancer as a contraindication, such a history is listed in the warning and precautions section of the package labeling, noting that this medication has not been studied in women with a history of breast cancer.[4]

Speaking of breast cancer survivors, a recent publication in JAMA Oncology[5] reported findings of a small 3-month trial of menopausal women with hormone receptor–positive breast cancer who were using aromatase inhibitors and experiencing vaginal dryness, sexual pain, or reduced desire. The investigators assessed the impact of a commercially available 3-month low-dose estradiol vaginal ring, marketed as Estring®, on serum estradiol levels. Compared with baseline, use of the ring was noted to improve atrophic vaginal symptoms, sexual desire, and sexual dysfunction. Use of the ring was not found to cause persistently elevated estradiol levels in any participant. The investigators, who are based at a US academic cancer center, indicated that their current practice is to continue the vaginal ring off-label in breast cancer survivors who are using aromatase inhibitors and experiencing symptomatic improvement, checking serum estradiol levels every several months.

In postmenopausal breast cancer survivors with receptor-positive tumors, adjuvant therapy with aromatase inhibitors profoundly reduces endogenous estrogen levels and reduces recurrence risk. Unfortunately, use of aromatase inhibitors also increases symptomatic genital atrophy. Understandably, oncologists have often been reluctant to use even low-dose vaginal estrogen in such patients. The information I have presented in this video indicates that both vaginal DHEA or prasterone vaginal ovules, as well as the 3-month low-dose estradiol vaginal ring, improve symptoms of genital atrophy without causing appreciable elevations in serum estradiol levels. This will be welcome news for women with symptomatic genital atrophy, including those who have been treated for estrogen-sensitive cancers.

Thank you for the honor of taking the time to view this video. I am Andrew Kaunitz.


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