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FDA Approves Intrarosa for Sexual Symptoms of Menopause

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On Nov. 17, 2016, the U.S. Food and Drug Administration (FDA) approved Intrarosa (chemical name: prasterone) to treat moderate to severe pain during sex in postmenopausal women.

Read the FDA media release.

Intrarosa is a bullet-shaped, creamy pill that is inserted into the vagina once per day at bedtime.

The active ingredient in Intrarosa is prasterone, which is also known as dehydroepiandrosterone (DHEA). DHEA is a hormone that is naturally made by the body. It is called a “precursor” hormone because it is made into female and male sex hormones — estrogens and androgens — by the body.

Because DHEA is converted into estrogen, there are concerns about the safety of Intrarosa for women who’ve been diagnosed with breast cancer, especially hormone-receptor-positive breast cancer, which is signaled by estrogen to grow and spread.

“DHEA blood levels are associated with higher breast cancer risk, especially estrogen-receptor-positive breast cancer,” said Brian Wojciechowski, M.D.,’s medical adviser. “It is unknown whether Intrarosa is associated with breast cancer. It simply has not been studied long enough.”

We do know that DHEA will decrease the effectiveness of hormonal therapy medicines. If you are taking an aromatase inhibitor, tamoxifen, or other hormonal therapy medicine to treat breast cancer or reduce the risk of being diagnosed with breast cancer, you should not use Intrarosa.

If you’re experiencing vaginal dryness and/or pain during sexual intercourse because of breast cancer treatment or menopause, it’s a good idea to talk to your doctor about non-hormonal treatment options first. Water-based lubricants and vaginal moisturizers may help ease the problem. It’s also a good idea to talk to your partner about how you’re feeling.

If non-hormonal options aren’t working, talk to your doctor about a low-dose vaginal estrogen or testosterone cream. Together, you and your doctor can talk about the risks and the benefits and decide if this might be right for you and your unique situation.

For more information, visit the Vaginal Dryness and Loss of Libido pages in the Treatment Side Effects section. You can talk to other women who are experiencing similar issues and read their suggestions for helping libido in the I Want My Mojo Back! thread in the Discussion Boards.

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