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
Takeaways
- 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.
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). 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. 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.
During double-blind visits, patients completed 1-month recall SFQ28 and FSDS-DAO surveys. 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 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. 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.
These results indicated improved outcomes from sildenafil cream among women with female sexual arousal disorder. Investigators recommended removing the restrictions to enroll sexual partners in future studies to evaluate a more diverse study population.1
Reference
- 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. Obstetrics & Gynecology. 2024. doi:10.1097/AOG.0000000000005648
- Potential first-in-category therapy for female sexual arousal disorder. Dare Bioscience. Accessed June 24, 2024. https://darebioscience.com/pipeline/sildenafil-cream/
