Female Sexual Dysfunction

Potential for Pharmacotherapy


The act of sex includes a woman's sexual self and self-image, intimate relationships, family, society and culture. The complexities of her environment, sexual and partner history, past relationships, mental health status, current medical problems and hormonal status all play a role. An interdisciplinary consensus conference panel expanded the former Diagnostic and Statistical Manual of Mental Disorders-IV classifications of female sexual dysfunction to include psychogenic and organic causes of desire, arousal, orgasm and sexual pain disorders that cause personal distress.

The US FDA Guidance paper details the recommendations for the clinical development of drugs for the treatment of female sexual dysfunction. In this document, great emphasis is placed on orgasm as a clinical trial endpoint and itwould appear that satisfactory sexual intercourse is of secondary importance to the Agency. However, there is no evidence to suggest that the majority of women correlate their sexual enjoyment and satisfaction with numbers of orgasms or even the likelihood of orgasm during a given sexual interaction. Nonetheless, any drug coming through the regulatory agency in the US will need to follow these recommendations.

Currently, there are six major pharmaceutical therapeutic paths being pursued for treatment of female sexual disorders and/or postmenopausal symptoms. These include dopaminergic agonists and related substances, melanocortin-stimulating hormones, adrenoceptor antagonists, nitric oxide delivery systems, prostaglandins, and androgens. A number of compounds that target these pathways are undergoing development for female sexual dysfunction. The array of pharmacological agents that are being developed for female sexual dysfunction must prove to be efficacious and have a good safety profile at a time when there are increasing worries that hormonal replacement with estrogen and progestogens are not safe. It is unclear if any of these pharmaceutical pathways will prove to be both safe and effective for the treatment of female sexual disorders; however, studies investigating this area will provide important scientific data for the future.

This is a preview of subscription content, log in to check access.

Fig. 1
Table I


  1. 1.

    Use of tradenames is for product identification purposes only and does not imply endorsement.


  1. 1.

    Fourcroy J. Issues and priorities in the development of drug treatments for female sexual dysfunction. Int J Impot Res 1998; 10 Suppl. 2: S121–S3

    PubMed  Article  Google Scholar 

  2. 2.

    Basson R. Expand the concepts of the human sex response cycle. J Sex Marital Ther 2001; 27(1): 33–44

    PubMed  Article  CAS  Google Scholar 

  3. 3.

    Basson R, Berman J, Burnett A, et al. Report of the international consensus development conference on female sexual dysfunction: definitions and classification. J Urol 2000 Mar; 163: 888–93

    PubMed  Article  CAS  Google Scholar 

  4. 4.

    Bancroft J, Graham CA, McCord C. Conceptualizing women's sexual problems. J Sex Marital Ther 2001; 27: 95–103

    PubMed  Article  CAS  Google Scholar 

  5. 5.

    Organization of medical consultations. ICUD — NGO in official relationship with the World Health Organization, International Society of Urology, and International Society for Sexual and Impotence Research [online]. Available from URL: www.congress-urology. org [Accessed 2003 Apr 16]

  6. 6.

    American Psychiatric Association. DSM-IV: diagnostic and statistical manual of mental disorders. 4th ed. Washington, DC: American Psychiatric Press, 1994

    Google Scholar 

  7. 7.

    Bygdeman M, Swahn ML. Replens versus dienoestrol cream in the symptomatic treatment of vaginal atrophy in postmenopausal women. Maturitas 1996 Apr; 23(3): 259–63

    PubMed  Article  CAS  Google Scholar 

  8. 8.

    Heiman JR. Female sexual response patterns: interactions of physiological, affective, and contextual cues. Arch Gen Psychiatry 1980 Nov 11; 37: 1311–6

    PubMed  Article  CAS  Google Scholar 

  9. 9.

    Simons J, Carey MP. Prevalence of sexual dysfunctions: results from a decade of research. Arch Sex Behav 2001; 30(2): 177–219

    PubMed  Article  CAS  Google Scholar 

  10. 10.

    Laumann EO, Paik A, Rosen RC. Sexual dysfunction in the United States; prevalence and predictors. JAMA 1999; 281(6): 537–44

    PubMed  Article  CAS  Google Scholar 

  11. 11.

    Laumann E, Michael R, Michaels S, et al. The social organization of sexuality. Chicago (IL): University of Chicago Press, 1994

    Google Scholar 

  12. 12.

    Frank E, Anderson C, Rubenstein D. Frequency of sexual dysfunction in normal couples. N Engl J Med 1978; 299: 111–5

    PubMed  Article  CAS  Google Scholar 

  13. 13.

    Avis N, Stellato R, Crawford S, et al. Is there an association between menopause status and sexual functioning? Menopause 2000; 7(5): 297–309

    PubMed  Article  CAS  Google Scholar 

  14. 14.

    Avis N. Sexual function and aging in men and women: community and population-based studies. J Gend Specif Med 2000; 3(2): 37–41

    PubMed  CAS  Google Scholar 

  15. 15.

    The National Council on Aging [online]. Available from URL: http://www.ncoa.org/content.cfm?sectionID=105&detail=128 [Accessed 2003 Apr 16]

  16. 16.

    Kingsberg SA. The impact of aging on sexual function in women and their partners. Arch Sex Behav 2002; 31(5): 431–7

    PubMed  Article  Google Scholar 

  17. 17.

    Clayton AH. Female sexual dysfunction related to depression and antidepressant medications. Curr Womens Health Rep 2002 Jun; 2(3): 182–7

    PubMed  Google Scholar 

  18. 18.

    Rosen RC, Lane RM, Menza M. Effects of SSRIs on sexual function: a critical review. J Clin Psychopharmacol 1999; 19: 67–85

    PubMed  Article  CAS  Google Scholar 

  19. 19.

    Fourcroy JL. Androgens and desire pharmacology in women: syllabus and presentation. First Annual Comprehensive Review of Sexual Medicine; 2002 Apr 18–21; Vancouver

  20. 20.

    Deliganis AV, Maravilla KR, Heiman JR, et al. Female genitalia: dynamic MR imaging with use of MS-325: initial experiences evaluating female sexual response. Radiology 2002; 225(3): 791–9

    PubMed  Article  Google Scholar 

  21. 21.

    Heiman H. Presentation: psychophysiological measurement perspective. First Annual Comprehensive Review of Sexual Medicine; 2002 Apr 18–21; Vancouver

  22. 22.

    Laan E, Everaerd W. Physiological measures of vaginal vasocongestion. Int J Impot Res 1998 May; 10 Suppl. 2: S107–10

    PubMed  Google Scholar 

  23. 23.

    US Food and Drug Administration. Guidance for Industry. Female sexual dysfunction: clinical development of drug products for treatment [online]. Available from URL: http://www.fda.gov/cder/guidance/3312dft.htm [Accessed Apr 16]

  24. 24.

    Rosen R, Brown C, Heiman J, et al. The female sexual function index (FSFI): a multidimensional self-report instrument for the assessment of female sexual function. J Sex Marital Ther 2000; 26: 191–208

    PubMed  Article  CAS  Google Scholar 

  25. 25.

    Derogatis L, Rosen R, Leiblum S, et al. The female sexual distress scale (FSDS): initial validation of a standardized scale for assessment of sexually related personal distress in women. J Sex Marital Ther 2002; 28(4): 317–30

    PubMed  Article  Google Scholar 

  26. 26.

    Quirk F, Heiman J, Rosen R, et al. Development of a sexual function questionnaire for clinical trials of female sexual dysfunction. J Womens Health Gend Based Med 2002 Apr; 11(3): 277–89

    PubMed  Article  Google Scholar 

  27. 27.

    Rosen RC. Assessment of female sexual dysfunction: review of validated methods. Fertil Steril 2002; 77 Suppl. 5: S89–93

    PubMed  Article  Google Scholar 

  28. 28.

    Crenshaw TL, Goldberg JP. Dopaminergic drugs. In: Crenshaw TL, Goldberg JP, editors. Sexual pharmacology. New York: WW Norton & Company, 1996: 369–88

    Google Scholar 

  29. 29.

    Jensvold MF, Plaut VC, Rojansky N, et al. Sexual side effects of psychotropic drugs in women and men. In: Jensvold MF, Halbreich U, Hamilton JA, editors. Psychopharmacology and women. Washington, DC: American Psychiatric Press Inc, 1996: 323–68

    Google Scholar 

  30. 30.

    Bancroft J. State of the art lecture: inhibitory mechanisms in men and women. First Annual Comprehensive Review of Sexual Medicine; 2002 Apr 18–21; Vancouver

  31. 31.

    Heaton J. New classification system for erectile dysfunction therapies. J Androl 1998; 19(4): 399–404

    PubMed  CAS  Google Scholar 

  32. 32.

    Gitlin MJ, Sun R, Altshuler L, et al. Bupropion-sustained release as a treatment for SSRI-induced sexual side effects. J Sex Marital Ther 2002 Mar–Apr; 28(2): 131–8

    PubMed  Article  Google Scholar 

  33. 33.

    O'Sullivan JD, Hughes AJ. Apomorphine-induced penile erections in Parkinson's disease. Mov Disord 1998; 13(3): 536–9

    PubMed  Article  Google Scholar 

  34. 34.

    Foreman MM. Disorders of sexual response: pioneering new pharmaceutical and therapeutic opportunities. Expert Opin Investig Drugs 1995; 4(7): 621–36

    Article  CAS  Google Scholar 

  35. 35.

    Alcantarra AG. A possible dopaminergic mechanism in the serotonergic antidepressant-induced sexual dysfunctions. J Sex Marital Ther 1999; 25(2): 125–9

    Google Scholar 

  36. 36.

    Foreman MM, Hall JL. Effects of D2-dopaminergic receptor stimulation on male rat sexual behavior. J Neural Transm 1987; 68: 153–70

    PubMed  Article  CAS  Google Scholar 

  37. 37.

    Everaerd W, Laan E. Drug treatments for women's sexual disorders. J Sex Res 2000; 37(3): 195–204

    Article  Google Scholar 

  38. 38.

    Wessells H, Gralnek D, Dorr R, et al. Effect of an alpha-melanocyte stimulating hormone analog on penile erection and sexual desire in men with organic erectile dysfunction. Urology 2000; 56(4): 641–6

    PubMed  Article  CAS  Google Scholar 

  39. 39.

    Wessells H, Fuclarelli K, Hansen J, et al. Synthetic melanotropic peptide initiates erections in men with psychogenic erectile dysfunction: double-blind, placebo controlled crossover study. J Urol 1998; 160(2): 389–93

    PubMed  Article  CAS  Google Scholar 

  40. 40.

    Rosen RC, Phillips NA, Gendrano NC. Oral phentolamine and female sexual arousal disorder: a pilot study. J Sex Marital Ther 1999; 25: 137–44

    PubMed  Article  CAS  Google Scholar 

  41. 41.

    Palatin Technologies [online]. Available from URL: www.palatin. com [Accessed 2003 April 16]

  42. 42.

    Rubio-Aurioles E, Rampazzo C, Hurley D, et al. Combination therapy for female arousal disorder: a clinical trial to evaluate the efficacy of a combination of phentolamine mesylate and apomorphine in the subjective response to video sexual stimulation [abstract]. Female Sexual Function Forum; 2001 Oct 25–28; Boston (MA), 84

  43. 43.

    Rubio-Aurioles E, Lopez M, Lipezker M, et al. Phentolamine mesylate in postmenopausal women with female sexual arousal disorder: a psychophysiological study. J Sex Marital Ther 2002; 28 Suppl. 1: 205–15

    Article  Google Scholar 

  44. 44.

    Physicians Desk Reference (PDR). 57th ed. Montvale (NJ): Thomson PDR, 2003

  45. 45.

    Gittelman M, Costabile RA, Peterson C, et al. In clinic evaluation of the safety and efficacy of topical alprostadil (PGE1) for the treatment of female sexual dysfunction [abstract 603]. J Urol 2002; 167(4): 151

    Google Scholar 

  46. 46.

    Islam A, Mitchel JT, Rosen R, et al. Topical alprostadil in the treatment of female sexual arousal disorder: a pilot study. J Sex Marital Ther 2001; 27: 541–9

    Article  Google Scholar 

  47. 47.

    NexMed (USA), Inc. [online]. Available from URL: http://www.nexmed.com/press/news118.htm [Accessed 2003 May29]

  48. 48.

    Krane R, Brock G, Eardley I, et al. Committee 8 oral nonendocrine treatment. In: Jardin A, Wagner G, Khoury S, et al., editors. Erectile dysfunction. Plymouth: Plymbridge Distributors Ltd, 2000: 730

    Google Scholar 

  49. 49.

    Goldstein I, Lue TF, Padma-Nathan H, et al. Oral sildenafil in the treatment of erectile dysfunction: Sildenatfil Study Group. N Engl J Med 1998; 338(20): 1397–404

    PubMed  Article  CAS  Google Scholar 

  50. 50.

    Laan E, van Lunsen RHW, Everaerd W, et al. The enhancement of vaginal vasocongestion by sildenafil in healthy premenopausal women. J Womens Health Gend Based Med 2002; 11(4): 357–66

    PubMed  Article  Google Scholar 

  51. 51.

    Basson R, Mclnnes R, Smoith M, et al. Efficacy and safety of sildenafil citrate in women with sexual dysfunction associated with female sexual arousal disorder. J Womens Health Gend Based Med 2002; 11(4): 367–77

    PubMed  Article  Google Scholar 

  52. 52.

    Kaplan SA, Reis RB, Kohn IJ, et al. Safety and efficacy of sildenafil in postmenopausal women with sexual dysfunction. Urology 1999; 53: 481–6

    PubMed  Article  CAS  Google Scholar 

  53. 53.

    Caruso S, Intelisano G, Lupo L, et al. Premenopausal women affected by sexual arousal disorder treated with sildenafil: a double-blind, crossover, placebo-controlled study. Br J Obstet Gynaecol 2001; 108: 623–8

    Article  CAS  Google Scholar 

  54. 54.

    Sipski ML, Rosen RC, Alexander CJ, et al. Sildenafil effects on sexual and cardiovascular responses in women with spinal cord injuries. Urology 2000; 55: 812–5

    PubMed  Article  CAS  Google Scholar 

  55. 55.

    Novavax, Inc. [online]. Available from URL: http://www.novavax.com/womens.html [Accessed 2003 May 29]

  56. 56.

    Meston CM, Worcel M. The effects of yohimbine plus Larginine glutamate on sexual arousal in postmenopausal women with sexual arousal disorder. Arch Sex Behav 2002; 31(4): 323–32

    PubMed  Article  Google Scholar 

  57. 57.

    Ito T, Trant AS, Polan ML. A double-blind placebo-controlled study of ArginMax, a nutritional supplement for enhancement of female sexual function. J Sex Marital Ther 2001; 27(5): 541–9

    PubMed  Article  CAS  Google Scholar 

  58. 58.

    Basson R, Bourgeois-Law G, Fourcroy J, et al. Androgen ‘deficiency’ in women is problematic. Med Aspects Hum Sex 2001 Sep; 1(6): 41–3

    Google Scholar 

  59. 59.

    Grumbach MM, Ducharme JR, Moloshok RE. On the fetal masculination action of certain oral progestins. J Clin Endocrinol Metab 1959; 19: 1369–80

    PubMed  Article  CAS  Google Scholar 

  60. 60.

    Kirk JM, Perry LA, Shand WS, et al. Female pseudohermaphroditism due to a maternal adrenocortical tumor. J Clin Encrocrinol Metab 1990; 70: 1280–4

    Article  CAS  Google Scholar 

  61. 61.

    Moore KL, Persaud T. The developing human. 6th ed. Philadelphia (PA): WB Saunders, 1998: 563

    Google Scholar 

  62. 62.

    Bachmann G, Bancroft J, Braunstein G, et al. Female androgen insufficiency: the Princeton consensus statement on definition, classification, and assessment. Fertil Steril 2002; 77(4): 660–5

    PubMed  Article  Google Scholar 

  63. 63.

    Bachmann G, Bancroft J, Braunstein G, et al. Androgen deficiency in women: definition, diagnosis and classification. Princeton Meeting; 2001 Jun 29; Princeton (NJ)

  64. 64.

    Bancroft J. Sexual effects of androgens in women: some theoretical considerations. Fertil Steril 2002 Apr; 77 Suppl. 4: 55–9

    Article  Google Scholar 

  65. 65.

    Women's Health Initiative Clinical Trial Writing Group. Risks and benefits of estrogen plus progestin in healthy postmenopausal women. JAMA 2002; 288(3): 321–33

    Article  Google Scholar 

  66. 66.

    Shifren JL, Braunstein GD, Simon JA, et al. Transdermal testosterone treatment in women with impaired sexual function after oophorectomy. N Engl J Med 2000; 343(10): 682–8

    PubMed  Article  CAS  Google Scholar 

  67. 67.

    Mazer NA. Testosterone deficiency in women: etiologies, diagnosis, and emerging treatments. Int J Fertil 2002; 47(2): 77–86

    CAS  Google Scholar 

  68. 68.

    Cellegy Pharmaceuticals Inc [online]. Available from URL: http://www.cellegy.com/home.html [Accessed 2003 Apr 16]

  69. 69.

    Antares Pharma [online]. Available from URL: http://www.antarespharma.com/content/news/news_06062001.html [Accessed 2003 Apr 16]

  70. 70.

    Phillips E, Bauman C. Safety surveillance of esterified estrogens-methyltestosterone (estratest and estratest HS) replacement therapy in the United States. Clin Ther 1997; 19(5): 1070–84

    PubMed  Article  CAS  Google Scholar 

  71. 71.

    Noven Pharmaceuticals, Inc. [online]. Available from URL: http://www.noven.com/research.htm [Accessed 2003 May 29]

  72. 72.

    Arlt W, Callies F, Vlumen JCV, et al. Dehydroepiandrosterone replacement in women with adrenal insufficiency. N Engl J Med 1999; 341(14): 1013–20

    PubMed  Article  CAS  Google Scholar 

  73. 73.

    Barnhart KT, Freeman E, Grisso JA, et al. The effect of dehydroepiandrosterone supplementation to symptomatic perimenopausal women on serum endocrine profiles, lipid parameters, and health-related quality of life. J Clin Endocrinol Metab 1999; 84: 3896–902

    PubMed  Article  CAS  Google Scholar 

  74. 74.

    Miller KK. Androgen deficiency in women. J Clin Endocrinol Metab 2001; 86: 2395–401

    PubMed  Article  CAS  Google Scholar 

  75. 75.

    US Food and Drug Administration. Dietary Supplement Health and Education Act Public Law 103-417 1994 [online]. Available from URL: http://www.fda.gov/opacom/laws/dshea.html [Accessed 2003 Apr 16]

  76. 76.

    Ferguson D. Randomized, placebo-controlled, double blind, crossover design trial of the efficacy and safety of Zestra for women in women with, and without, female sexual arousal disorder. J Sex Marital Ther 2003; 29(1): 33–44

    PubMed  Article  Google Scholar 

  77. 77.

    Grand Opening [online]. Available from URL: http://www.grandopening.com/ [Accessed 2003 Apr 4]

Download references


To the many companies who were helpful in identifying current research including: Lilly/ICOS, Nastech Pharmaceutical Company, Inc., Nexmed, Qualilife, Proctor & Gamble, Vivus, Zonagen, Antares Pharma and Cellegy Pharmaceuticals, Inc. Particular thanks to Drs R Basson, D Ferguson and J Heiman. Complicated switch box from Dr R Rosen. The authors have provided no information on sources of funding or on conflicts of interest directly relevant to the content of this review.

Author information



Corresponding author

Correspondence to Dr Jean L. Fourcroy.

Rights and permissions

Reprints and Permissions

About this article

Cite this article

Fourcroy, J.L. Female Sexual Dysfunction. Drugs 63, 1445–1457 (2003). https://doi.org/10.2165/00003495-200363140-00002

Download citation


  • Sexual Dysfunction
  • DHEA
  • Sexual Arousal
  • Sexual Response
  • Female Sexual Function Index