Helping Women Rejoice Again: New treatment improves sexual function in postmenopausal women

Sexual empowerment not only applies to equality in the boardroom of the work place, but in the bedroom as well. Equality in comfort and sexual satisfaction, and equality in the types and numbers of treatments available. Women who have had their last menses sometimes say good-bye to their enjoyable sex lives because of pain during sexual activity, due to vulvar or vaginal changes, lack of lubrication, all of which can affect one’s libido. Societal cues, shame, or embarrassment about this lack of sexual equality are not being addressed enough and there are solutions. These physical symptoms are brought on by menopause, whether medically-induced menopause or natural menopause, but because the symptoms may “sneak up” on a woman, the connection to menopause is often lost, and women commonly assume this is just another symptom of getting older, like arthritis. There is certainly nothing natural about a sudden halt in one’s sexual life when pain and dryness interfere. We have answers.

Why the Disconnect?
Many postmenopausal women are relatively unaware of how the symptoms of menopause affect them sexually, and what treatments are available, according to findings presented at the Annual Meeting of the North American Menopause Society.

Results of the Women’s EMPOWER survey reveal that women generally didn’t recognize vulvar and vaginal atrophy symptoms, and were reluctant to discuss them with their healthcare professionals. This second part is most concerning to me. I’m available to discuss, mitigate, and resolve sexual issues. Participants in the survey also reported that they lacked knowledge about therapeutic options to alleviate these bothersome symptoms. When compared with six previously conducted surveys — REVEAL, VIVA US, Healthy Women #1, REVIVE, CLOSER North America and Healthy Women #2 — evaluating knowledge, behaviors and attitudes related to vulvar and vaginal atrophy, EMPOWER demonstrated yet again that women failed to recognize vulvar and vaginal atrophy symptoms, and were reluctant to discuss them. Further, participants reported that they lacked knowledge about therapeutic options to alleviate the symptoms. But, there is no reason to suffer in silence. Speak up!

Experts such as myself, a reproductive endocrinologist, sexual medicine and menopause specialist, and Clinical Professor at George Washington University in Washington, DC, and my colleagues seek to address these issues and have released a study on a new treatment that will enable women to reclaim their sexual vitality.

The REJOICE Trial
TX-004HR is as soft gel capsule containing low-dose, solubilized, natural, bioidentical 17 B-estradiol.  Our team team conducted a phase 3, randomized, double-blind, placebo-controlled, multicenter REJOICE trial that demonstrated this treatment to be safe and effective for treating moderate to severe dyspareunia (painful intercourse) in postmenopausal women with vulvar and vaginal atrophy (VVA). In total, 764 women were eligible to participate in the study, of which 704 (92%) completed the study.

The study used the Female Sexual Function Index (FSFI) as a measurement of the impact of this treatment on sexual function. The FSFI is a self-reporting tool to assess sexual function during the past 4 weeks. It consists of 19 questions categorized into six domains of sexual function (desire, arousal, lubrication, orgasm, satisfaction, and pain).

VVA affects more than 30 million women who go untreated, in part, because of the perceived risks of estrogen, which I have explained in an earlier post,  Estrogen and Breast Cancer Risk: Separating Fact from Fiction.  But this new treatment  aims to alleviate the symptoms without adding any risk by providing a treatment that goes to the source of the issue, the vagina and vulva, with little or no systemic absorption of estrogen. The REJOICE study compared the effects of 12-weeks of treatment with TX-004HR at varied doses with placebo in postmenopausal women (40 to 75 years old) with VVA and moderate to severe dyspareunia (i.e., difficult or painful intercourse).

The Good News
The research team found that TX-004HR improved sexual function in postmenopausal women with moderate to severe VVA and dyspareunia. After 12 weeks, all three TX-004HR doses increased the average total FSFI score.

This treatment shows promise for women who  experience these symptoms and they should talk with their partners and their medical team to address issues as they arise. If these symptoms are affecting your sex life, I encourage you to give our office a call to help develop a plan for a healthy and happier sexual life going forward.

 

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