Changes from baseline to week 12 were measured.1 A female sexual arousal disorder diagnosis and status as the woman’s primary sexual dysfunction concern were determined through a 1-on-1 clinical interview. Participants underwent a no-drug run-in period for 28 days, with eligibility determined by compliance with recorded sexual and adverse events. Following the no-drug run-in period, eligible participants were randomized 1:1 to receive sildenafil cream or placebo cream for a 12-week double-blind period.
| Area of Research | Focus | Expected Outcomes | Challenges |
|---|---|---|---|
| Larger clinical trials | Efficacy and safety validation | Better approval pathway | Funding, recruitment difficulties |
| Combination therapies | Sildenafil with hormonal or psychological treatments | Enhanced effects | Interaction management |
| Delivery methods innovations | Topical, transdermal, or implantable forms | Increased convenience | Development complexity |
| Long-term safety studies | Effects of prolonged use | Safety confirmation | Ethical and logistical hurdles |
Baseline scores included responses and electronic diary data at the end of the run-in period, and double-blind visits occurred at weeks 4, 8, and 12.
Your Winona prescription includes unlimited, 24/7 messaging with your board-certified doctor. You can ask questions about your Sildenafil Arousal Cream, discuss your symptoms, or explore Winona’s other treatments at any time through the secure Patient Portal. When you need more Sildenafil Arousal Cream, simply request a reorder through your Patient Portal, and the Patient Care Team will arrange shipment. We evaluated the efficacy and safety of sildenafil citrate in spontaneously or surgically postmenopausal women with female sexual arousal disorder (FSAD). Sildenafil (a 50 mg dose adjustable to 100 or 25 mg) was evaluated in a 12-week, double-blind, placebo controlled study in 202 postmenopausal women with FSAD who had protocol specified estradiol and free testosterone concentrations, and/or were receiving estrogen and/or androgen replacement therapy.
Patients were excluded if emotional, relationship or historical abuse issues contributed significantly to sexual dysfunction. Primary end points were questions 2 (increased genital sensation during intercourse or stimulation) and 4 (increased satisfaction with intercourse and/or foreplay) from the Female Intervention Efficacy Index (FIEI). Secondary end points were the remaining questions from this index, the Sexual Function Questionnaire and sexual activity event log questions. Significant improvements in FIEI questions 2 (p = 0.017) and 4 (p = 0.015) were noted with sildenafil compared with placebo. For women with FSAD without concomitant hypoactive sexual desire disorder (HSDD) sildenafil was associated with significantly greater improvement in 5 of 6 FIEI items compared with placebo (p <0.02).
No significant improvements were shown for women with concomitant HSDD. Most adverse events were mild to moderate with headache, flushing, rhinitis, nausea and visual symptoms reported most frequently. Sildenafil was effective and well tolerated in postmenopausal women with FSAD without concomitant HSDD or contributory emotional, relationship or historical abuse issues. All patients had protocol specified estradiol and free testosterone concentrations or were receiving estrogen and/or androgen replacement therapy. 1 : Report of the International Consensus Development Conference on Female Sexual Dysfunction: definitions and classifications. During double-blind visits, patients completed 1-month recall SFQ28 and FSDS-DAO surveys.
| Benefit | Explanation | Evidence Level | Notes |
|---|---|---|---|
| Improved Blood Flow | Enhances genital blood circulation | Moderate | May aid sexual arousal |
| Increased Libido | Possible enhancement of sexual desire | Limited | Varies among women |
| Better Orgasm Response | Some reports of improved orgasm | Anecdotal | Not scientifically proven |
| Enhanced Clitoral Sensitivity | Possible increase in sensation | Theoretical | Needs more research |
Within 24 hours of a sexual event, participants recorded data in an electronic diary. Participants’ response to the question “Did you consider sexual activity satisfactory for you?” in the electronic sildenafil pfizer 100g diary after a sexual event was the secondary outcome of the analysis, measured as the changes in the number and proportion of satisfying events from baseline to week 12.
There were 200 participants included in the final analysis, 101 of whom received sildenafil cream and 99 placebo cream.
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Of participants, 99 and 94, respectively, were in the intention-to-treat (ITT) analysis and 90 and 84, respectively, completed all study visits.1 When measuring outcomes based on the SFQ28 Arousal Sensation domain, increased efficacy was reported for the sildenafil cream group vs the placebo cream group. However, statistically significant improvements were not observed for either coprimary endpoint during the double-blind period, nor were the number of satisfying events improved. In the ITT population, patients in the sildenafil cream group had significantly improved SFQ28 Desire domain scores at week 8, which was considered an exploratory endpoint. Women with female sexual arousal disorder with concomitant orgasmic dysfunction had lessened treatment benefits at week 12 vs those with other sexual dysfunction diagnoses.1 The largest 12-week improvements in sexual dysfunction from sildenafil cream were observed among women with only female sexual desire disorder as their sexual dysfunction. These patients had significant improvements in the SFQ28 Arousal Sensation domain, SFQ28 Desire domain, and SFQ28 Orgasm domain vs placebo users.
2 : Female sexual arousal disorder: new insights. 5 : Development of human and rabbit vaginal smooth muscle cell cultures: effects of vasoactive agents on intracellular levels of cyclic nucleotides. 7 : Sildenafil, a novel effective oral therapy for male erectile dysfunction. 8 : Effect of sildenafil on subjective and physiologic parameters of the female sexual response in women with sexual arousal disorder. 9 : Plasma membrane estrogen sildenafil syrup receptors are coupled to endothelial nitric-oxide synthase through Galpha(i).
10 : Androgen-dependent nitric oxide release in rat penis correlates with levels of constitutive nitric oxide synthase isoenzymes. 11 Guay, A., Munarriz, R., Jacobson, M.A., Talakoub, L., Goldstein, I., Traish, A. et-al: Androgen values in premenopausal women without sexual dysfunction. Presented at International Society for the Study of Women's Sexual Health, Vancouver, British Columbia, Canada, October 10–13, 2002 Google Scholar 13 : Development of a sexual function questionnaire for clinical trials of female sexual dysfunction. J Womens Health Gend Based Med2002; 11: 277.
14 : The use of the Female Intervention Efficacy Index (FIEI) as an immediate outcome measure of medical intervention to treat female sexual dysfunction. 15 : Efficacy and safety of sildenafil citrate in women with sexual dysfunction associated with female sexual arousal disorder. J Womens Health Gend Based Med2002; 11: 367. 16 : Transdermal testosterone treatment in women with impaired sexual function after oophorectomy. 17 : Premenopausal women affected by sexual arousal disorder treated with sildenafil: a double-blind, cross-over, placebo-controlled study. These results indicated improved outcomes from sildenafil cream among women with female sexual arousal disorder.
While oral sildenafil has shown little efficacy compared to placebo and high rates of side effects, topical sildenafil cream 3.6% (sildenafil cream) is another method of managing female sexual arousal disorder symptoms. Topical administration of sildenafil may also reduce side effects and provide a more immediate biological efficacy response. Sildenafil cream is an investigational proprietary topical formulation designed for the treatment of female sexual arousal disorder.2 Phase 1 and phase 2 studies have indicated safety, tolerance, and efficacy from sildenafil cream use. Investigators conducted a clinical trial to evaluate the safety and efficacy of sildenafil cream among women with female sexual arousal disorder.1 Participants included healthy premenopausal women aged at least 18 years and their sexual partners. Female sexual arousal disorder outcomes were assessed using the Arousal Sensation domain of the Sexual Function Questionnaire (SFQ38) and question 14 of the Female Sexual Distress Scale—Desire, Arousal, Orgasm (FSDS-DAO). Investigators recommended removing the restrictions to enroll sexual partners in future studies to evaluate a more diverse study population.1 Johnson I, Thurman A, Cornell K, et al.
Preliminary efficacy of topical sildenafil cream for the treatment of female sexual arousal disorder: A randomized controlled trial.
18 : Effects of ovariectomy and estrogen and androgen treatment on sildenafil-mediated changes in female genital blood flow and vaginal lubrication in the animal model. 19 : The role of androgen in the maintenance of sexual functioning in oophorectomized women. 20 : Testosterone enhances estradiol's effects on postmenopausal bone density sildenafil pick up and sexuality. From the Department of Urology, University of California-Los Angeles Medical Center, Los Angeles, California, Departments of Obstetrics and Gynecology, and Psychiatry, Feinberg School of Medicine, Northwestern Memorial Hospital, Chicago, Illinois, and Pfizer Global Research and Development, Groton, Connecticut, and Sandwich, United Kingdom Topical sildenafil cream is effective for improving outcomes in women with female sexual arousal disorder, according to a recent study published in Obstetrics & Gynecology.1 Topical sildenafil cream has shown promising results in improving sexual arousal outcomes for women with female sexual arousal disorder. The study, published in Obstetrics & Gynecology, found that women using sildenafil cream experienced significant improvements in sexual arousal sensation compared to those using a placebo.
Phase 1 and phase 2 studies indicated that sildenafil cream is safe, well-tolerated, and effective for treating female sexual arousal disorder. Significant improvements were observed in the SFQ28 Desire domain scores at week 8, especially in women with only female sexual desire disorder. Researchers suggest future studies should include a more diverse population by removing restrictions on enrolling sexual partners, to better evaluate the cream's efficacy. Female sexual arousal disorder, presenting in approximately 20% of US women, refers to the inability to attain or maintain sexual arousal and often leads to distress and interpersonal difficulty. Currently, no pharmacologic treatments have received FDA approval for managing this condition in the United States. Potential first-in-category therapy for female sexual arousal disorder. Sildenafil (Viagra, Revatio) reduced antidepressant-associated sexual dysfunction in women in a randomized controlled trial, which investigators characterize as the first conducted in women with this adverse drug effect.