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New Treatments for Female Sexual Dysfunction: Are they Safe and Effective for Older Post-Menopausal Women?

  • Janelle Sobecki-RauschEmail author
  • Stacy Tessler Lindau
Clinical Therapeutics (B McCarthy and R Segraves, Section Editors)
Part of the following topical collections:
  1. Topical Collection on Clinical Therapeutics
  2. Topical Collection on Clinical Therapeutics

Abstract

Purpose of Review

Several new modalities for treatment of female sexual function problems have been approved by the US Food and Drug Administration (FDA). This review summarizes current evidence about recently approved medications to inform treatment of sexual function problems in women older than 65 years.

Recent Findings

Published studies leading to FDA approval of treatment modalities were efficacy trials not widely applicable to the general population. The clinical effectiveness of these modalities remains unknown. Although some studies have included post-menopausal women, few have included women older than 65 years.

Summary

Health care providers need current information about safety and effectiveness of these new treatments for all women, including the fast-growing population of older post-menopausal women. Exclusion of older women from studies of treatments for female sexual function problems presents a barrier to treatment.

Keywords

Sexual dysfunction Post-menopausal Women 

Notes

Acknowledgements

Stacy Tessler Lindau reports a grant from the Ellie Fund at Jewish Women’s Foundation of Metropolitan Chicago to the University of Chicago; reports being a member of the board of the Scientific Network on Female Sexual Health and Cancer; reports being a founder, co-owner, and investor in NowPow, LLC; reports investments in Glenbervie Health; reports stocks and mutual funds, including some with healthcare relevance, that are managed by third parties; and reports being contracted to be a peer reviewer for UpToDate, which will pay small fees to the University of Chicago for this activity.

Compliance with Ethical Standards

Conflict of Interest

Janelle Sobecki-Rausch declares no potential conflicts of interest.

Human and Animal Rights and Informed Consent

This article does not contain any studies with human or animal subjects performed by any of the authors.

References

Papers of particular interest, published recently, have been highlighted as: •• Of major importance

  1. 1.
    Ortman JM, Velkoff VA, Hogan H. An aging nation: the older population in the United States. Suitland: United States Census Bureau, Economics and Statistics Administration, US Department of Commerce; 2014.Google Scholar
  2. 2.
    Lindau ST, Schumm LP, Laumann EO, Levinson W, O'muircheartaigh CA, Waite LJ. A study of sexuality and health among older adults in the United States. N Engl J Med. 2007;357(8):762–74.CrossRefGoogle Scholar
  3. 3.
    Laumann EO, Waite LJ. Sexual dysfunction among older adults: prevalence and risk factors from a nationally representative US probability sample of men and women 57–85 years of age. J Sex Med. 2008;5(10):2300–11.CrossRefGoogle Scholar
  4. 4.
    US Food and Drug Administration Drugs@FDA: FDA Approved Drug Products. www.accessdata.fda.gov/scripts/cder/daf. Accessed October 18, 2018.
  5. 5.
    Association AP. Diagnostic and statistical manual of mental disorders (DSM-5®). Philadelphia: American Psychiatric Pub; 2013.CrossRefGoogle Scholar
  6. 6.
    Kingsberg SA, Wysocki S, Magnus L, Krychman ML. Vulvar and vaginal atrophy in postmenopausal women: findings from the REVIVE (REal Women’s VIews of Treatment Options for Menopausal Vaginal ChangEs) survey. J Sex Med. 2013;10(7):1790–9.CrossRefGoogle Scholar
  7. 7.
    Simon JA, Nappi RE, Kingsberg SA, Maamari R, Brown V. Clarifying Vaginal Atrophy’s Impact on Sex and Relationships (CLOSER) survey: emotional and physical impact of vaginal discomfort on north American postmenopausal women and their partners. Menopause. 2014;21(2):137–42.CrossRefGoogle Scholar
  8. 8.
    Soe LH, Wurz GT, Kao CJ, DeGregorio MW. Ospemifene for the treatment of dyspareunia associated with vulvar and vaginal atrophy: potential benefits in bone and breast. Int J Health. 2013;5(1):605–11.Google Scholar
  9. 9.
    Archer DF, Carr BR, Pinkerton JV, Taylor HS, Constantine GD. Effects of ospemifene on the female reproductive and urinary tracts: translation from preclinical models into clinical evidence. Menopause (New York, NY). 2015;22(7):786.CrossRefGoogle Scholar
  10. 10.
    Bachmann GA, Komi JO, Group OS. Ospemifene effectively treats vulvovaginal atrophy in postmenopausal women: results from a pivotal phase 3 study. Menopause. 2010;17(3):480–6.Google Scholar
  11. 11.
    Portman DJ, Bachmann GA, Simon JA, Group OS. Ospemifene, a novel selective estrogen receptor modulator for treating dyspareunia associated with postmenopausal vulvar and vaginal atrophy. Menopause. 2013;20(6):623–30.CrossRefGoogle Scholar
  12. 12.
    Rutanen E-M, Heikkinen J, Halonen K, Komi J, Lammintausta R, Ylikorkala O. Effects of ospemifene, a novel SERM, on hormones, genital tract, climacteric symptoms, and quality of life in postmenopausal women: a double-blind, randomized trial. Menopause. 2003;10(5):433–9.CrossRefGoogle Scholar
  13. 13.
    Simon J. Efficacy and safety of daily ospemifene 60 mg for up to 1 year when used in the treatment of vulvar and vaginal atrophy in postmenopausal women. Menopause. 2012;19(12):1397–8.Google Scholar
  14. 14.
    Simon J, Bachmann G, Goldstein S, Lin V, Portman D, Phelps M. Evaluation of the safety of daily ospemifene 60 mg for up to 1 year when used in the treatment of vulvar and vaginal atrophy in postmenopausal women. Climacteric. 2011;14(suppl 1):87.Google Scholar
  15. 15.
    Simon JA, Lin VH, Radovich C, Bachmann GA, Group OS. One-year long-term safety extension study of ospemifene for the treatment of vulvar and vaginal atrophy in postmenopausal women with a uterus. Menopause. 2013;20(4):418–27.Google Scholar
  16. 16.
    Cui Y, Zong H, Yan H, Li N, Zhang Y. The efficacy and safety of ospemifene in treating dyspareunia associated with postmenopausal vulvar and vaginal atrophy: a systematic review and meta-analysis. J Sex Med. 2014;11(2):487–97.CrossRefGoogle Scholar
  17. 17.
    Constantine G, Graham S, Portman DJ, Rosen RC, Kingsberg SA. Female sexual function improved with ospemifene in postmenopausal women with vulvar and vaginal atrophy: results of a randomized, placebo-controlled trial. Climacteric. 2015;18(2):226–32.CrossRefGoogle Scholar
  18. 18.
    Wiegel M, Meston C, Rosen R. The female sexual function index (FSFI): cross-validation and development of clinical cutoff scores. J Sex Marital Ther. 2005;31(1):1–20.CrossRefGoogle Scholar
  19. 19.
    Stahl SM, Sommer B, Allers KA. Multifunctional pharmacology of flibanserin: possible mechanism of therapeutic action in hypoactive sexual desire disorder. J Sex Med. 2011;8(1):15–27.CrossRefGoogle Scholar
  20. 20.
    Portman DJ, Brown L, Yuan J, Kissling R, Kingsberg SA. Flibanserin in postmenopausal women with hypoactive sexual desire disorder: results of the PLUMERIA study. J Sex Med. 2017;14(6):834–42.CrossRefGoogle Scholar
  21. 21.
    Simon JA, Kingsberg SA, Shumel B, Hanes V, Garcia M Jr, Sand M. Efficacy and safety of flibanserin in postmenopausal women with hypoactive sexual desire disorder: results of the SNOWDROP trial. Menopause. 2014;21(6):633–40.CrossRefGoogle Scholar
  22. 22.
    DeRogatis L, Clayton A, Lewis-D'Agostino D, Wunderlich G, Fu Y. Validation of the female sexual distress scale-revised for assessing distress in women with hypoactive sexual desire disorder. J Sex Med. 2008;5(2):357–64.CrossRefGoogle Scholar
  23. 23.
    Clayton AH, Segraves RT, Leiblum S, Basson R, Pyke R, Cotton D, et al. Reliability and validity of the Sexual Interest and Desire Inventory–Female (SIDI-F), a scale designed to measure severity of female hypoactive sexual desire disorder. J Sex Marital Ther. 2006;32(2):115–35.CrossRefGoogle Scholar
  24. 24.
    Portman DJ, Johnson D, Yuan J, Barbour K, Kissling R. Flibanserin in postmenopausal women with hypoactive sexual desire disorder: results of the PLUMERIA study. Menopause. 2016;23(12):1393.Google Scholar
  25. 25.
    Jaspers L, Feys F, Bramer WM, Franco OH, Leusink P, Laan ET. 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(4):453–62.CrossRefGoogle Scholar
  26. 26.
    Joffe HV, Chang C, Sewell C, Easley O, Nguyen C, Dunn S, et al. FDA approval of flibanserin—treating hypoactive sexual desire disorder. N Engl J Med. 2016;374(2):101–4.CrossRefGoogle Scholar
  27. 27.
    Archer DF, Labrie F, Bouchard C, Portman DJ, Koltun W, Cusan L, et al. Treatment of pain at sexual activity (dyspareunia) with intravaginal dehydroepiandrosterone (prasterone). Menopause. 2015;22(9):950–63.CrossRefGoogle Scholar
  28. 28.
    Labrie F, Archer DF, Koltun W, Vachon A, Young D, Frenette L, et al. Efficacy of intravaginal dehydroepiandrosterone (DHEA) on moderate to severe dyspareunia and vaginal dryness, symptoms of vulvovaginal atrophy, and of the genitourinary syndrome of menopause. Menopause. 2016;23(3):243–56.CrossRefGoogle Scholar
  29. 29.
    Labrie F, Derogatis L, Archer DF, Koltun W, Vachon A, Young D, et al. Effect of intravaginal prasterone on sexual dysfunction in postmenopausal women with vulvovaginal atrophy. J Sex Med. 2015;12(12):2401–12.CrossRefGoogle Scholar
  30. 30.
    Society NAM. The role of local vaginal estrogen for treatment of vaginal atrophy in postmenopausal women: 2007 position statement of The North American Menopause Society. Menopause (New York, NY). 2007;14(3 Pt 1):355.Google Scholar
  31. 31.
    Constantine GD, Simon JA, Pickar JH, Archer DF, Kushner H, Bernick B, et al. The REJOICE trial: a phase 3 randomized, controlled trial evaluating the safety and efficacy of a novel vaginal estradiol soft-gel capsule for symptomatic vulvar and vaginal atrophy. Menopause. 2017;24(4):409–16.CrossRefGoogle Scholar
  32. 32.
    •• Constantine GD, Bouchard C, Pickar JH, Archer DF, Graham S, Bernick B, et al. Consistency of effect with a low-dose, estradiol vaginal capsule (TX-004HR): evaluating improvement in vaginal physiology and moderate-to-severe dyspareunia in subgroups of postmenopausal women. J Women’s Health. 2017;26(6):616–23 Age-related efficacy analysis performed in a population of women 62 years or older. CrossRefGoogle Scholar
  33. 33.
    Sobecki-Rausch JN, Brown O, Gaupp CL, editors. Sexual dysfunction in lesbian women: a systematic review of the literature. Seminars in reproductive medicine. Stuttgart: Thieme Medical Publishers; 2017.Google Scholar
  34. 34.
    Singal AG, Higgins PD, Waljee AK. A primer on effectiveness and efficacy trials. Clin Transl Gastroenterol. 2014;5(1):e45.CrossRefGoogle Scholar
  35. 35.
    Centers for Medicare and Medicaid Services CMS Fast Facts. https://www.cms.gov/Research-Statistics-Data-and-Systems/Statistics-Trends-and-Reports/CMS-Fast-Facts/index.html. Accessed October 18, 2018.
  36. 36.
    Centers for Medicare and Medicaid Services Prescription Drug Benefit Manual Chapter 6. https://www.cms.gov/Medicare/Prescription-Drug-Coverage/PrescriptionDrugCovContra/Downloads/Part-D-Benefits-Manual-Chapter-6.pdf.
  37. 37.
    Centers for Medicare and Medicaid Services Formulary Guidance CY19 Formulary Reference FIle https://www.cms.gov/Medicare/Prescription-Drug-Coverage/PrescriptionDrugCovContra/RxContracting_FormularyGuidance.html. Accessed October 28, 2018.

Copyright information

© Springer Science+Business Media, LLC, part of Springer Nature 2019

Authors and Affiliations

  1. 1.Division of Gynecologic Oncology, Department of Obstetrics and GynecologyUniversity of Wisconsin-MadisonMadisonUSA
  2. 2.Departments of Obstetrics and Gynecology and Medicine-GeriatricsThe University of ChicagoChicagoUSA

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