Sildenafil cream demonstrates safety, efficacy in phase 2b study for female sexual arousal disorder

Unlike the oral formulations of PDE-5 inhibitors, Sildenafil Cream is applied locally to

• 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.

the vaginal tissue and is designed to facilitate vasodilation and increased blood flow

• Sildenafil works by relaxing blood vessels, increasing blood flow to genital areas.
• Female sexual arousal disorder may potentially be treated with sildenafil.
• Research shows mixed results regarding sildenafil's effectiveness in women.
• Sildenafil is not approved by the FDA specifically for women’s sexual problems.
• Possible risks for women include headaches and low blood pressure.
• Always consult a healthcare provider before trying sildenafil for women.

directly to the genital tissue to improve the physical arousal response symptoms commonly

Trend	Description	Potential Impact
Development of women-specific formulations	Customized doses and delivery methods	Improved safety and efficacy
Combination therapies	Sildenafil combined with other agents	Potentially enhanced outcomes
Non-oral delivery systems	Topicals, patches, or injectables	Increased convenience and quicker onset
Personalized medicine approaches	Genetic testing to optimize treatment	Higher success rates with fewer side effects
Increased clinical trials in women	More robust evidence for approval	Better guideline development

associated with FSAD while avoiding systemic side effects observed with oral formulations of sildenafil.

Society and culture

Expression of cAMP and cGMP-phosphodiesterase isoenzymes 3, 4, and 5 in the human clitoris: immunohistochemical and molecular biology study. 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.

Key takeaways

Arch Sex Behav 2002;31:393–400. In vitro functional responses of isolated human vaginal tissue to selective phosphodiesterase inhibitors. J Sex Med 2007;4:1604–9. doi: 10.1111/j.1743-6109.2007.00595.x Uckert S, Oelke M, Albrecht K, Breitmeier D, Kuczyk MA, Hedlund P. Expression and distribution of key enzymes of the cyclic GMP signaling in the human clitoris: relation to phosphodiesterase type 5 (PDE5).

Marketing and sales

J Sex Med 2007;4:602–8. doi: 10.1111/j.1743-6109.2007.00490.x Sexual motivation in couples coping with female sexual interest/arousal disorder: a comparison with control couples. A systematic literature review of health-related quality of life measures for women with hypoactive sexual desire disorder and female sexual interest/arousal disorder. Efficacy of flibanserin in women with hypoactive sexual desire disorder: results from the BEGONIA trial. Simon JA, blue sildenafil Thorp J, Millheiser L. Phase 1 and Phase 2a Clinical Studies, Previously Completed In a Phase 1 clinical study in 20 healthy post-menopausal women, topical sildenafil

• Awareness of sildenafil's potential side effects helps women make informed choices.
• Women should avoid using sildenafil with nitrates to prevent dangerous drops in blood pressure.
• Proper diagnosis of sexual dysfunction can guide appropriate treatment options.
• Scientific research continues to explore safer, women-specific sexual health drugs.
• Sildenafil’s long-term effects on women are not yet fully understood.
• Healthcare providers can help determine if sildenafil is appropriate for individual cases.

cream was safe and well tolerated at clinically relevant doses, and study subjects reported favorable product characteristics: easy to use and readily absorbed.

Parameter	Description	Typical Values	Notes
Absorption Rate	Time to reach peak plasma levels	30-120 minutes	Varies with food intake
Half-Life	Duration of drug activity	4 hours	Metabolized mainly in liver
Bioavailability	Percentage of drug absorbed	40-50%	Affected by gastric pH
Metabolism	Enzymes involved	CYP3A4	Liver metabolism mainly
Excretion	How drug is eliminated	Feces and urine	Mainly fecal excretion

In a Phase 2a study in women with FSAD (15 pre-menopausal and 16 post-menopausal),

Product	Dosage	Quantity + Bonus	Price
Viagra Generic	200mg	10 Pills	40.96€ 39.01€	Buy
Viagra Generic	50mg	20 Pills	40.52€ 38.59€	Buy
Viagra Generic	200mg	30 + 2 Pills	83.07€ 79.11€	Buy
Kamagra	100mg	360 + 6 Pills	839.95€ 799.95€	Buy
Viagra Generic	100mg	30 + 4 Pills	60.91€ 58.01€	Buy
Kamagra Polo	100mg	84 + 4 Pills	244.49€ 232.85€	Buy
Viagra Generic	100mg	120 + 6 Pills	149.50€ 142.38€	Buy
Viagra Generic	150mg	30 + 2 Pills	72.32€ 68.88€	Buy
Kamagra Polo	100mg	272 + 12 Pills	622.94€ 593.28€	Buy
Kamagra Oral Jelly	100mg	10 Sachets	54.55€ 51.95€	Buy
Kamagra Soft Tabs	100mg	180 + 8 Pills	425.45€ 405.19€	Buy
Viagra Generic	150mg	270 + 10 Pills	326.61€ 311.06€	Buy
Viagra Generic	50mg	30 + 4 Pills	54.26€ 51.68€	Buy

Sildenafil Cream increased measurable blood flow to the genital tissue compared to placebo cream.

Why trust our experts?

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. 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.

What special precautions should I follow?

Nurnberg HG, Hensley PL, Heiman JR, Croft HA, Debattista C, Paine S. 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.

Pulmonary hypertension

Effect of intravaginal dehydroepiandrosterone (Prasterone) on libido and sexual dysfunction in postmenopausal women. Treatment of hypoactive sexual desire disorder in premenopausal women: efficacy of flibanserin in the VIOLET Study. Treatment of hypoactive sexual desire disorder in premenopausal sildenafil oral strips 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. Further, data from a thermography study in healthy women demonstrated significantly greater increases in genital temperature after administration of Sildenafil Cream compared to placebo cream,

Patients and Methods

We also found significant reductions in several measures of sexual distress and interpersonal difficulties among this 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.

A note about sex and gender

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. 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.

Mohamed Alhefnawy1*, Abdulla Esawy2, Mohamed Abdelazeem1, Mohamed Elnamoury3, Ahmed Eissa4, Ahmed Zoair4, Ahmed Ghaith4, Ayman Hagras4 and Khaled Almekaty4

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)? 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)? indicating a positive impact on genital blood flow during the 30-minute testing

Other Treatments for Low Libido

Flibanserin for premenopausal hypoactive sexual desire disorder: pooled analysis of clinical trials. J Womens Health (Larchmt) 2019;28:769–77. Long-term safety and efficacy of bremelanotide for hypoactive sexual desire disorder. Bremelanotide for the treatment of hypoactive sexual desire disorder: two randomized phase 3 trials. Female sexual arousal disorder (FSAD) FSAD, as described in the Diagnostic and Statistical Manual 4th Edition (DSM-IV), is a condition characterized as a persistent or recurrent inability to attain or maintain sufficient genital arousal (an adequate lubrication-swelling response) during sexual activity, frequently resulting in distress or interpersonal difficulty.

Though you cannot place an order quite yet...

Of the various types of female sexual dysfunction disorders, FSAD is most analogous to erectile dysfunction (ED) in men. There are currently no FDA-approved therapies for FSAD. A meta-analysis of 95 studies from 2000-2014 indicated prevalence of Female Sexual Dysfunction sildenafil 100 mg cost in premenopausal women worldwide is 41%, and difficulty with arousal alone is 23%.1 Market research estimates: 33% of US women aged 21 to 60 (~ 20 million women), experience symptoms of low or no sexual arousal.2,310 million women in the US are considered distressed and actively seeking treatment.2 33% of US women aged 21 to 60 (~ 20 million women), experience symptoms of low or no sexual arousal.2,3 10 million women in the US are considered distressed and actively seeking treatment.2 To put the market opportunity for an FDA-approved FSAD treatment in context, a PDE5 inhibitor utilized in an ED medication for men – Viagra® — peaked at $2.05 billion in sales in 2012.4 Orally administered sildenafil, a phosphodiesterase-5 (PDE-5) inhibitor, received FDA approval in 1998 for the treatment of erectile dysfunction in men and is marketed under the brand name Viagra®. Given the underlying pathophysiologic similarities of ED and FSAD, using sildenafil to direct blood to the genitals before sexual activity could provide a potential improvement in genital arousal response and overall sexual experience for women as it does in men. Sildenafil Cream, 3.6% is an investigational proprietary topical formulation of sildenafil being developed as a first-in-category option for women for the treatment of FSAD. session, with statistical separation from placebo within the first 15 minutes after dosing.

• Female sexual dysfunction affects millions worldwide, prompting research into treatments.
• Sildenafil is part of a broader conversation about women’s sexual health innovations.
• The role of sildenafil in improving orgasm quality is still being studied.
• It is essential to distinguish between clinical trial results and off-label use.
• Some women experience mood improvement alongside physical effects with sildenafil.
• Education about both benefits and risks is crucial for women considering sildenafil.