EXECUTIVE SUMMARY

Although older women are sexually active beyond their seventh decade of life, results of a new study indicate that at least one in seven women ages 65-79 suffers from hypoactive sexual desire dysfunction.

  • Hypoactive sexual desire disorder is characterized by low sexual desire that causes marked distress or interpersonal difficulty. The condition is not the result of a coexisting medical or psychiatric condition, problems within the relationship, or the effects of a medication or other drug substance.
  • Healthcare providers must engage in honest and open discussions with their patients as they age regarding desire, mood, vaginal dryness, and pelvic floor issues to determine whether these factors are affecting a woman’s desire or ability to be sexual.

Although older women are sexually active beyond their seventh decade of life, results of a new study indicate that at least one in seven women ages 65-79 suffers from hypoactive sexual desire dysfunction (HSDD).1 HSDD is characterized by low sexual desire that causes marked distress or interpersonal difficulty. The condition is not the result of a coexisting medical or psychiatric condition, problems within the relationship, or the effects of a medication or other drug substance. Research indicates the condition is thought to affect one in 10 women.2

In the new data, designed as a questionnaire-based, cross-sectional study, more than 1,500 Australian women were assessed for sexual function and sexual distress as defined by the Female Sexual Function Index and the Female Sexual Distress Scale-Revised. The group consisted of 52.6% partnered women, with a mean age of 71 years. Within this group, 88% were found to experience low sexual desire, 15.5% experienced sexually related personal distress, and 13.6% exhibited HSDD, defined as the presence of both low sexual desire and sexually related personal distress. This percentage was higher than what had been reported previously for women in this age group and similar to the prevalence reported for younger women, researchers noted.

Although HSDD was found to be more common in women with partners, data indicate that unpartnered older women are sexually active and may be distressed by low sexual desire.1 Independent factors included experiencing vaginal dryness during intercourse in the past month, experiencing moderate to severe depressive symptoms, and demonstrating symptomatic pelvic floor dysfunction.

“This study demonstrates that healthcare providers need to have honest and open discussions with their patients as they age with regard to desire, mood, vaginal dryness, and pelvic floor issues to determine whether these factors are affecting a woman’s desire or ability to be sexual,” says JoAnn Pinkerton, MD, NCMP, executive director of the Cleveland-based North American Menopause Society.

Searching for More Options

In 2015, the FDA approved flibanserin (Addyi), the first drug specifically indicated for hypoactive sexual desire dysfunction. (Contraceptive Technology Update reported on the regulatory move in November 2015, “FDA approves first treatment for sexual desire disorder,” available at: http://bit.ly/2irJaYh.) Originally developed as an antidepressant, flibanserin works on three neurotransmitters: dopamine, norepinephrine, and serotonin. Flibanserin works by increasing levels of dopamine and norepinephrine, while dropping levels of serotonin. This drug interaction is intended to increase chemicals that help promote sexual desire and decrease the one that can suppress desire.

Addyi comes with a boxed warning to highlight the risks of severe hypotension and syncope in patients who drink alcohol during treatment with the drug, in those who also use moderate or strong CYP3A4 inhibitors, and in those who suffer from liver impairment. The drug is contraindicated in these patients. In addition, the FDA requires that three studies in women be conducted to better understand the known serious risks of the interaction between Addyi and alcohol.

Patients using flibanserin should take the drug, dosed as a 100 mg tablet, at bedtime to help decrease the risk of adverse events occurring due to possible hypotension, syncope, and central nervous system depression, such as sleepiness and sedation. Women should discontinue treatment after eight weeks if they do not report an improvement in sexual desire and associated distress. The most common adverse reactions associated with drug use are dizziness, somnolence, nausea, fatigue, insomnia, and dry mouth. Clinicians must be trained and certified to prescribe Addyi. (For more information, please visit: http://bit.ly/2knu6QC.)

A 2016 overview of clinical evidence on use of the drug concludes that treatment with flibanserin, on average, resulted in one-half additional satisfying sexual event (SSE) per month while statistically and clinically significantly increasing the risk of dizziness, somnolence, nausea, and fatigue.3

The analysis is based on five published and three unpublished studies including 5,914 women. Women’s mean global impression of improvement scores indicated minimal improvement to no change, the analysis noted.

Overall, the quality of the evidence was graded as very low, the article concluded. Before the drug can be recommended in guidelines and clinical practice, future studies should include women from diverse populations, particularly women with comorbidities, medication use, and surgical menopause, it stated.1

Scientists are studying the possible use of bremelanotide as a subcutaneous, on-demand, as-needed treatment for premenopausal women diagnosed with HSDD. Bremelanotide, which is a melanocortin 4 receptor agonist drug candidate, is a synthetic peptide analog of the naturally occurring hormone alpha-MSH (melanocyte-stimulating hormone). It is under development by Palatin Technologies, Inc. The company announced in November 2016 favorable top-line results from the Reconnect Studies, its Phase III clinical trial program of bremelanotide.

The Reconnect Studies consist of two randomized, double-blinded, placebo-controlled studies comparing the efficacy and safety of bremelanotide vs. placebo in premenopausal women diagnosed with HSDD. The Reconnect Studies randomized 1,267 women with HSDD. The primary efficacy analysis population was the modified intent-to-treat patient population, consisting of 1,202 women presenting with HSDD in the United States and Canada. Patients self-administered either 1.75 mg of bremelanotide or placebo as needed in anticipation of sexual activity. The double-blind or efficacy portion of each study consisted of a 24-week treatment evaluation period. The open-label safety extension portion of the Reconnect Studies is ongoing. Publication of the data is forthcoming.

Hypoactive sexual desire disorder is the most prevalent form of female sexual dysfunction, says Sheryl Kingsberg, PhD, professor of reproductive biology at Case Western Reserve University School of Medicine and division chief, OB/GYN Behavioral Medicine, at University Hospitals Cleveland Medical Center. Data indicated “significant” reduction in distress with use of bremelanotide, noted Kingsberg, who was an investigator in the clinical trial.

REFERENCES

  1. Zeleke BM, Bell RJ, Billah B, Davis SR. Hypoactive sexual desire dysfunction in community-dwelling older women. Menopause 2016 Nov 7. [Epub ahead of print].
  2. Shifren JL, Monz BU, Russo PA, et al. Sexual problems and distress in United States women: Prevalence and correlates. Obstet Gynecol 2008;112:970-978.
  3. Jaspers L, Feys F, Bramer WM, et al. Efficacy and safety of flibanserin for the treatment of hypoactive sexual desire disorder in women: A systematic review and meta-analysis. JAMA Intern Med 2016;176:453-462.