Skip to main content
Top
Published in: Current Sexual Health Reports 1/2019

01-03-2019 | Dyspareunia | Clinical Therapeutics (B McCarthy and R Segraves, Section Editors)

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

Authors: Janelle Sobecki-Rausch, Stacy Tessler Lindau

Published in: Current Sexual Health Reports | Issue 1/2019

Login to get access

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.
Literature
1.
go back to reference 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. 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.
2.
go back to reference 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.CrossRefPubMedPubMedCentral 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.CrossRefPubMedPubMedCentral
3.
go back to reference 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.CrossRefPubMedPubMedCentral 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.CrossRefPubMedPubMedCentral
5.
go back to reference Association AP. Diagnostic and statistical manual of mental disorders (DSM-5®). Philadelphia: American Psychiatric Pub; 2013.CrossRef Association AP. Diagnostic and statistical manual of mental disorders (DSM-5®). Philadelphia: American Psychiatric Pub; 2013.CrossRef
6.
go back to reference 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.CrossRefPubMed 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.CrossRefPubMed
7.
go back to reference 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.CrossRefPubMed 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.CrossRefPubMed
8.
go back to reference 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. 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.
9.
go back to reference 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.CrossRef 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.CrossRef
10.
go back to reference 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.PubMed 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.PubMed
11.
go back to reference 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.CrossRefPubMed 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.CrossRefPubMed
12.
go back to reference 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.CrossRefPubMed 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.CrossRefPubMed
13.
go back to reference 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. 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.
14.
go back to reference 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. 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.
15.
go back to reference 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.PubMed 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.PubMed
16.
go back to reference 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.CrossRefPubMed 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.CrossRefPubMed
17.
go back to reference 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.CrossRefPubMed 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.CrossRefPubMed
18.
go back to reference 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.CrossRefPubMed 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.CrossRefPubMed
19.
go back to reference 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.CrossRefPubMed 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.CrossRefPubMed
20.
go back to reference 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.CrossRefPubMed 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.CrossRefPubMed
21.
go back to reference 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.CrossRefPubMed 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.CrossRefPubMed
22.
go back to reference 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.CrossRefPubMed 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.CrossRefPubMed
23.
go back to reference 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.CrossRefPubMed 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.CrossRefPubMed
24.
go back to reference 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. 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.
25.
go back to reference 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.CrossRefPubMed 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.CrossRefPubMed
26.
go back to reference 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.CrossRefPubMed 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.CrossRefPubMed
27.
go back to reference 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.CrossRefPubMed 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.CrossRefPubMed
28.
go back to reference 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.CrossRefPubMed 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.CrossRefPubMed
29.
go back to reference 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.CrossRefPubMed 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.CrossRefPubMed
30.
go back to reference 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. 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.
31.
go back to reference 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.CrossRefPubMedPubMedCentral 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.CrossRefPubMedPubMedCentral
32.
go back to reference •• 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. CrossRef •• 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. CrossRef
33.
go back to reference 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. 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.
Metadata
Title
New Treatments for Female Sexual Dysfunction: Are they Safe and Effective for Older Post-Menopausal Women?
Authors
Janelle Sobecki-Rausch
Stacy Tessler Lindau
Publication date
01-03-2019
Publisher
Springer US
Keyword
Dyspareunia
Published in
Current Sexual Health Reports / Issue 1/2019
Print ISSN: 1548-3584
Electronic ISSN: 1548-3592
DOI
https://doi.org/10.1007/s11930-019-00187-x

Other articles of this Issue 1/2019

Current Sexual Health Reports 1/2019 Go to the issue

Female Sexual Dysfunction and Disorders (T Lorenz and R Nappi, Section Editors)

Dyspareunia in Women: Updates in Mechanisms and Current/Novel Therapies

Male and Female Surgical Interventions (A Burnett and C Carson, Section Editors)

Female Cosmetic Genital Reconstruction: a Review of Current Trends, Treatments, and Techniques

Clinical Therapeutics (B McCarthy and R Segraves, Section Editors)

Pornography Use in Adult Mixed-Sex Romantic Relationships: Context and Correlates

Clinical Therapeutics (B McCarthy and R Segraves, Section Editors)

Cultural Differences in the Treatment of Sex Problems

Female Sexual Dysfunction and Disorders (T Lorenz and R Nappi, Section Editors)

Sexual Violence Identification and Women’s Sexual Well-Being