Sildenafil cream for female sexual arousal disorder available to prescribe in select states
The only statistically significant change noted for the ITT population was a statistically significant increase in the SFQ28 Desire domain score at week 8 for sildenafil cream users (P=.04, Table 2), which was a predefined exploratory endpoint.
| Risk | Details | Precaution |
|---|---|---|
| Cardiovascular complications | Increased blood pressure, arrhythmias | Screen for cardiovascular disease before use |
| Drug interactions | Severe hypotension, adverse effects from combinations | Complete medication history before prescribing |
| Allergic reactions | Rashes, swelling, difficulty breathing | Discontinue and seek medical attention if occurs |
| Psychological dependency | Over-reliance on medication for arousal | Counseling for emotional health |
| Misuse and overdose | Increased adverse effects | Strict adherence to prescribed dose |
Efficacy Endpoints for the Intention-to-Treat Population* When the efficacy endpoints were compared in an exploratory post hoc analysis based on enrollment sexual dysfunction diagnoses, women with female sexual arousal disorder with concomitant orgasmic dysfunction did not experience as large a treatment benefit at week 12 from sildenafil cream use (data not shown, all P>.22) as those with other sexual dysfunction diagnoses. Specifically, women with female sexual arousal disorder as their only sexual dysfunction, although uncommon, experienced the largest improvements in sexual function at week 12 with sildenafil cream (Table 3), which were not statistically significant, likely because of the small sample size. When participants with female sexual arousal disorder with concomitant orgasmic dysfunction and female sexual arousal disorder with concomitant genital pain were removed from the analysis, a subset of participants (sildenafil 33 and placebo 32) remained. This subset of participants, who had female sexual arousal disorder only or female sexual arousal disorder with concomitant decreased desire, experienced significant improvements with sildenafil cream use at week 12 in the coprimary endpoint of SFQ28 Arousal Sensation domain (P=.04, Table 3) and had large improvements in the SFQ28 Desire domain (P=.06, Table 3) and the SFQ28 Orgasm domain (P=.19, Table 3) at week 12 compared with placebo cream users.
How Does Viagra Affect Women?
The only statistically significant change noted for the ITT population was a statistically significant increase in the SFQ28 Desire domain score at week 8 for sildenafil cream users (P=.04, Table 2), which was a predefined exploratory endpoint. Efficacy Endpoints for the Intention-to-Treat Population* When the efficacy endpoints were compared in an exploratory post hoc analysis based on enrollment sexual dysfunction diagnoses, women with female sexual arousal disorder with concomitant orgasmic dysfunction did not experience as large a treatment benefit at week 12 from sildenafil cream use (data not shown, all P>.22) as those with other sexual dysfunction diagnoses. Specifically, women with female sexual arousal disorder as their only sexual dysfunction, although uncommon, experienced the largest improvements in sexual function at week 12 with sildenafil cream (Table 3), which were not statistically significant, likely because of the small sample size. When participants with female sexual arousal disorder with concomitant orgasmic dysfunction and female sexual arousal disorder with concomitant genital pain were removed from the analysis, a subset of participants (sildenafil 33 and placebo 32) remained. This subset of participants, who had female sexual arousal disorder only or female sexual arousal disorder with concomitant decreased desire, experienced significant improvements with sildenafil cream use at week 12 in the coprimary endpoint of SFQ28 Arousal Sensation domain (P=.04, Table 3) and had large improvements in the SFQ28 Desire domain (P=.06, Table 3) and the SFQ28 Orgasm domain (P=.19, Table 3) at week 12 compared with placebo cream users.
A Note on Gender and Sex Terminology
Efficacy Endpoints for Enrollment Female Sexual Dysfunction Diagnoses Subset Population* Although the subset population of women randomized to sildenafil cream with either female sexual arousal disorder only or female sexual arousal disorder with concomitant decreased desire did not demonstrate statistically significant decreased sexual distress as measured by the coprimary endpoint of FSDS-DAO question 14 (P=.95, Table 3), which assesses concern about difficulties with sexual arousal, we found that several other FSDS-DAO questions, which asked about generalized feelings related to sexual distress and interpersonal difficulties, showed significant improvement with sildenafil cream compared with placebo cream (questions 3, 5 and 10, all P≤.04, Table 3) in this exploratory subset. The total FSDS-DAO score decreased by about 7 points for sildenafil cream users in the subset population (a clinically meaningful decrease in sexual distress11) compared with a 2-point decrease for placebo cream users (P=.10). Topical sildenafil cream used over 12 weeks among healthy premenopausal women with female sexual arousal disorder did not show statistically significant improvement over placebo in the coprimary (SFQ28 Arousal Sensation domain, FSDS-DAO question 14) or secondary (mean number and mean proportion of satisfactory sexual events) endpoints among the ITT population, all of whom had female sexual arousal disorder but had a wide variety of concomitant sexual dysfunction diagnoses or symptoms, during this exploratory phase 2b study. This study required the participants' main sexual dysfunction to be related to arousal because the mechanism of action of topical sildenafil citrate is to augment genital tissue blood flow to treat female sexual arousal disorder.18–28 Not surprisingly, we saw that female sexual arousal disorder was often accompanied by concomitant sexual dysfunction diagnoses or symptoms.29,30 When the efficacy endpoints were compared in an exploratory post hoc analysis among a subset of women with female sexual arousal disorder only or female sexual arousal disorder with concomitant decreased desire, we found sildenafil 25 mg tablets either trends or significant improvements in sexual functioning with sildenafil cream compared with placebo cream across multiple aspects of sexual function. We also found significant reductions in several measures of sexual distress and interpersonal difficulties among this 50 mg sildenafil price subset population.
Study Design
Although we recognize that exploratory post hoc subset analyses must be interpreted with caution and can introduce type I errors, we believe that the trends observed in this subset population are promising, are clinically meaningful, and warrant further study because an important objective of this exploratory phase 2 study was to identify which women with female sexual arousal disorder are most likely to benefit from the mechanism of action of sildenafil citrate to increase genital blood flow.18–28 Participants with female sexual arousal disorder with concomitant orgasmic dysfunction did not derive as much benefit from sildenafil cream use. Although it was important to assess this subset population in this exploratory study, it was expected that women with female sexual arousal disorder with concomitant orgasmic dysfunction may not benefit as greatly from sildenafil cream because orgasmic dysfunction is often associated with neurologic problems or other comorbid medical or psychological conditions that would not be treated by the mechanism of action of sildenafil citrate (ie, increased blood flow to the genital tissue)18–28 and can be challenging to distinguish from female sexual arousal disorder temporally in terms of onset. A limitation of this exploratory study was that it was underpowered to demonstrate statistically significant changes in the primary and secondary efficacy endpoints among the ITT population, all of whom had female sexual arousal disorder but were heterogeneous in their concomitant sexual dysfunction diagnoses or symptoms. Because this study was the first efficacy study of topical sildenafil cream among healthy premenopausal women with a main complaint of female sexual arousal disorder and because there are no FDA-approved treatments for female sexual arousal disorder, the main benefits of this study were to characterize the sexual response affected by arousal dysfunction, to evaluate the patient population based on concomitant diagnoses and medications, to identify endpoints to take forward in clinical development, and to provide data for psychometric validation of the study endpoints, including identifying the magnitude of within-patient change corresponding to a meaningful within-patient improvement. We based our sample size calculations on previous studies of FDA-approved products for hypoactive sexual desire disorder with or without concomitant decreased sexual arousal16,17,31–34 because there are no approved products for female sexual arousal disorder. Efficacy Endpoints for Enrollment Female Sexual Dysfunction Diagnoses Subset Population* Although the subset population of women randomized to sildenafil cream with either female sexual arousal disorder only or female sexual arousal disorder with concomitant decreased desire did not demonstrate statistically significant decreased sexual distress as measured by the coprimary endpoint of FSDS-DAO question 14 (P=.95, Table 3), which assesses concern about difficulties with sexual arousal, we found that several other FSDS-DAO questions, which asked about generalized feelings related to sexual distress and interpersonal difficulties, showed significant improvement with sildenafil cream compared with placebo cream (questions 3, 5 and 10, all P≤.04, Table 3) in this exploratory subset.
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The total FSDS-DAO score decreased by about 7 points for sildenafil cream users in the subset population (a clinically meaningful decrease in sexual distress11) compared with a 2-point decrease for placebo cream users (P=.10). Topical sildenafil cream used over 12 weeks among healthy premenopausal women with female sexual arousal disorder did not show statistically significant improvement over placebo in the coprimary (SFQ28 Arousal Sensation domain, FSDS-DAO question 14) or secondary (mean number and mean proportion of satisfactory sexual events) endpoints among the ITT population, all of whom had female sexual arousal disorder but had a wide variety of concomitant sexual dysfunction diagnoses or symptoms, during this exploratory phase 2b study. This study required the participants' main sexual dysfunction to be related to arousal because the mechanism of action of topical sildenafil citrate is to augment genital tissue blood flow to treat female sexual arousal disorder.18–28 Not surprisingly, we saw that female sexual arousal disorder was often accompanied by concomitant sexual dysfunction diagnoses or symptoms.29,30 When the efficacy endpoints were compared in an exploratory post hoc analysis among a subset of women with female sexual arousal disorder only or female sexual arousal disorder with concomitant decreased desire, we found sildenafil 25 mg tablets either trends or significant improvements in sexual functioning with sildenafil cream compared with placebo cream across multiple aspects of sexual function. We also found significant reductions in several measures of sexual distress and interpersonal difficulties among this 50 mg sildenafil price subset population. Although we recognize that exploratory post hoc subset analyses must be interpreted with caution and can introduce type I errors, we believe that the trends observed in this subset population are promising, are clinically meaningful, and warrant further study because an important objective of this exploratory phase 2 study was to identify which women with female sexual arousal disorder are most likely to benefit from the mechanism of action of sildenafil citrate to increase genital blood flow.18–28 Participants with female sexual arousal disorder with concomitant orgasmic dysfunction did not derive as much benefit from sildenafil cream use. Although it was important to assess this subset population in this exploratory study, it was expected that women with female sexual arousal disorder with concomitant orgasmic dysfunction may not benefit as greatly from sildenafil cream because orgasmic dysfunction is often associated with neurologic problems or other comorbid medical or psychological conditions that would not be treated by the mechanism of action of sildenafil citrate (ie, increased blood flow to the genital tissue)18–28 and can be challenging to distinguish from female sexual arousal disorder temporally in terms of onset. A limitation of this exploratory study was that it was underpowered to demonstrate statistically significant changes in the primary and secondary efficacy endpoints among the ITT population, all of whom had female sexual arousal disorder but were heterogeneous in their concomitant sexual dysfunction diagnoses or symptoms. Because this study was the first efficacy study of topical sildenafil cream among healthy premenopausal women with a main complaint of female sexual arousal disorder and because there are no FDA-approved treatments for female sexual arousal disorder, the main benefits of this study were to characterize the sexual response affected by arousal dysfunction, to evaluate the patient population based on concomitant diagnoses and medications, to identify endpoints to take forward in clinical development, and to provide data for psychometric validation of the study endpoints, including identifying the magnitude of within-patient change corresponding to a meaningful within-patient improvement. We based our sample size calculations on previous studies of FDA-approved products for hypoactive sexual desire disorder with or without concomitant decreased sexual arousal16,17,31–34 because there are no approved products for female sexual arousal disorder. We reviewed the published data for female sexual dysfunction treatments and expected a two-point increase in the SFQ28 domains and a 0.5-point decrease in question 14 of the FSDS-DAO.
What are the potential side effects of Viagra for women?
Sildenafil treatment of women with antidepressant-associated sexual dysfunction: a randomized controlled trial. doi: 10.1001/jama.300.4.395 Berman JR, Berman LA, Toler SM, Gill J, Haughie S; Sildenafil Study Group. Bremelanotide for female sexual dysfunctions in premenopausal women: a randomized, placebo-controlled dose-finding trial. Womens Health (Lond) 2016;12:325–37. Effect of intravaginal dehydroepiandrosterone (Prasterone) on libido and sexual dysfunction in postmenopausal women.
Corresponding author
Treatment of sildenafil citrate 120 mg hypoactive sexual desire disorder in premenopausal women: efficacy of flibanserin in the VIOLET Study. Treatment of hypoactive sexual desire disorder in premenopausal women: efficacy of flibanserin in the DAISY study. doi: 10.1016/s0090-4295(02)01663-1 Mayer M, Stief CG, Truss MC, Uckert S. Phosphodiesterase inhibitors in female sexual dysfunction. Expression of cAMP and cGMP-phosphodiesterase isoenzymes 3, 4, and 5 in the human clitoris: immunohistochemical and molecular biology study.
What side effects can low dose sildenafil cause?
doi: 10.1016/j.urology.2005.11.055 Park K, Moreland RB, Goldstein I, Atala A, Traish A. Sildenafil inhibits phosphodiesterase type 5 in human clitoral corpus cavernosum smooth muscle. Traish AM, Kim NN, Munarriz R, Moreland R, Goldstein I. Biochemical and physiological mechanisms of female genital sexual arousal. Arch Sex Behav 2002;31:393–400. Although we did not achieve these changes in the entire ITT population, we consistently achieved or exceeded these improvements among the subset population of women with female sexual arousal disorder only or female sexual arousal disorder with concomitant decreased desire. As seen in registration trials for hypoactive sexual desire disorder treatments,16,17,31–34 another limitation of our study was the relatively homogeneous population of college-educated White women. We acknowledge that the requirement to enroll sexual partners likely limited enrollment of Hispanic and non-Hispanic Black women and hypothesize that removing this requirement from future studies will result in a more diverse patient population.
- Some studies suggest sildenafil might help women with sexual arousal disorder.
- The drug's vasodilating effects can have cardiovascular implications in women.
- Women should be cautious of counterfeit or unapproved sildenafil products.
- Combining sildenafil with other ED drugs in women is not recommended without medical advice.
- Psychological support remains an important aspect of treating female sexual dysfunction.
- Ongoing clinical trials aim to establish the safety and efficacy of sildenafil for women.
In particular, in an exploratory analysis of a subset of women with female sexual arousal disorder with or without concomitant decreased desire, topical sildenafil increased sexual arousal sensation, desire, and orgasm and reduced sexual distress. Will individual participant data be available (including data dictionaries)?
- The market for female sexual enhancement drugs is growing, including sildenafil research.
- Women should be aware of potential drug interactions when using sildenafil.
- Female sexual health involves multiple factors, not just blood flow.
- Sildenafil may not be effective for all women due to physiological differences.
- Regular follow-up with healthcare providers can optimize treatment and safety.
- Lifestyle factors such as stress and hormonal balance influence female libido.
What data in particular will be shared? When will data be available (start and end dates)?
- The legality of women using sildenafil varies by country and local regulations.
- Lifestyle modifications can complement medication for better sexual health outcomes.
- Women with diabetes may have different responses to sildenafil therapy.
- The stigma surrounding female sexual dysfunction can hinder treatment seeking.
- Advances in research are aimed at developing female-specific ED medications.
- Open discussions with physicians are essential for safe and effective treatments.
By what access criteria will data be shared (including with whom, for what types of analyses, and by what mechanism)? doi: 10.1016/j.sxmr.2020.05.001 Witherow-Parkanyi M. Female sexual interest/arousal disorder: history of diagnostic considerations and their implications for clinical practice.
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We reviewed the published data for female sexual dysfunction treatments and expected a two-point increase in the SFQ28 domains and a 0.5-point decrease in question 14 of the FSDS-DAO. Although we did not achieve these changes in the entire ITT population, we consistently achieved or exceeded these improvements among the subset population of women with female sexual arousal disorder only or female sexual arousal disorder with concomitant decreased desire. As seen in registration trials for hypoactive sexual desire disorder treatments,16,17,31–34 another limitation of our study was the relatively homogeneous population of college-educated White women. We acknowledge that the requirement to enroll sexual partners likely limited enrollment of Hispanic and non-Hispanic Black women and hypothesize that removing this requirement from future studies will result in a more diverse patient population. In particular, in an exploratory analysis of a subset of women with female sexual arousal disorder with or without concomitant decreased desire, topical sildenafil increased sexual arousal sensation, desire, and orgasm and reduced sexual distress.
Inclusion Criteria
Will individual participant data be available (including data dictionaries)? What data in particular will be shared? When will data be available (start and end dates)? By what access criteria will data be shared (including with whom, for what types of analyses, and by what mechanism)? doi: 10.1016/j.sxmr.2020.05.001 Witherow-Parkanyi M.
Key takeaways
Female sexual interest/arousal disorder: history of diagnostic considerations and their implications for clinical practice. Assessing the clinical efficacy of sildenafil for the treatment of female sexual dysfunction. J Sex Med 2010;7:858–72. Symptoms and associated impact in pre- and postmenopausal women with sexual arousal disorder: a concept elicitation study. Nurnberg HG, Hensley PL, Heiman JR, Croft HA, Debattista C, Paine S. Assessing the clinical efficacy of sildenafil for the treatment of female sexual dysfunction. J Sex Med 2010;7:858–72. Symptoms and associated impact in pre- and postmenopausal women with sexual arousal disorder: a concept elicitation study. Nurnberg HG, Hensley PL, Heiman JR, Croft HA, Debattista C, Paine S.
Adverse effects
In vitro functional responses of isolated human vaginal tissue to selective phosphodiesterase inhibitors. Sildenafil treatment of women with antidepressant-associated sexual dysfunction: a randomized controlled trial. doi: 10.1001/jama.300.4.395 Berman JR, Berman LA, Toler SM, Gill J, Haughie S; Sildenafil Study Group. Bremelanotide for female sexual dysfunctions in premenopausal women: a randomized, placebo-controlled dose-finding trial. Womens Health (Lond) 2016;12:325–37. Effect of intravaginal dehydroepiandrosterone (Prasterone) on libido and sexual dysfunction in postmenopausal women. Treatment of sildenafil citrate 120 mg hypoactive sexual desire disorder in premenopausal women: efficacy of flibanserin in the VIOLET Study. Treatment of hypoactive sexual desire disorder in premenopausal women: efficacy of flibanserin in the DAISY study. doi: 10.1016/s0090-4295(02)01663-1 Mayer M, Stief CG, Truss MC, Uckert S. Phosphodiesterase inhibitors in female sexual dysfunction. Expression of cAMP and cGMP-phosphodiesterase isoenzymes 3, 4, and 5 in the human clitoris: immunohistochemical and molecular biology study.
| Age Group | Considerations | Recommended Dosage | Notes |
|---|---|---|---|
| 20-30 years | Generally healthy | 25 mg | Consult doctor if contraindicated |
| 31-50 years | Possible hormonal changes | 25-50 mg | Monitor for side effects |
| 51+ years | Increased health risks | 25 mg | Under medical advice |
| Postmenopausal | Effectiveness varies | Variable | Focus on overall health |
doi: 10.1016/j.urology.2005.11.055 Park K, Moreland RB, Goldstein I, Atala A, Traish A. Sildenafil inhibits phosphodiesterase type 5 in human clitoral corpus cavernosum smooth muscle. Traish AM, Kim NN, Munarriz R, Moreland R, Goldstein I. Biochemical and physiological mechanisms of female genital sexual arousal.
Route of administration
Arch Sex Behav 2002;31:393–400. In vitro functional responses of isolated human vaginal tissue to selective phosphodiesterase inhibitors.