Topical sildenafil cream 3.6% significantly enhanced outcomes among women diagnosed with female sexual arousal disorder. This was particularly evident in an exploratory subset of women presenting with this disorder, whether or not they also experienced concomitant decreased desire.
Abstract
OBJECTIVE:
The primary goal of this study was to evaluate the efficacy of a 3.6% topical sildenafil cream among healthy premenopausal women suffering from female sexual arousal disorder.
METHODS:
A comprehensive phase 2b, exploratory, randomized, placebo-controlled, double-blind trial was conducted focusing on the sildenafil cream. The co-primary efficacy endpoints were determined by the shifts from baseline to week 12 in the Arousal Sensation domain of the SFQ28 (Sexual Function Questionnaire) and question 14 of the FSDS-DAO (Female Sexual Distress Scale—Desire, Arousal, Orgasm).
RESULTS:
A total of 200 women diagnosed with female sexual arousal disorder were randomly assigned to either the sildenafil cream (n=101) or a placebo cream (n=99). Out of these participants, 174 completed the study (sildenafil group 90, placebo group 84). In the intention-to-treat (ITT) population, which encompassed women with solely female sexual arousal disorder and those with concomitant sexual dysfunction diagnoses or genital pain, the sildenafil cream group exhibited superior improvements in the SFQ28 Arousal Sensation domain scores. However, there were no statistically significant differences between the sildenafil and placebo cream users regarding the co-primary and secondary efficacy endpoints. An exploratory post hoc analysis of the ITT population, specifically those diagnosed with female sexual arousal disorder with or without concomitant decreased desire, showed significant enhancements in their SFQ28 Arousal Sensation domain score (least squares mean 2.03 [SE 0.62]) versus the placebo group (least squares mean 0.08 [SE 0.71], P=.04). This subgroup also displayed larger mean enhancements in the SFQ28 Desire and Orgasm domain scores. Furthermore, this subgroup experienced a notable reduction in sexual distress and interpersonal challenges due to sildenafil cream usage, as evidenced by the FSDS-DAO responses to questions 3, 5, and 10 (all P≤.04).
CONCLUSION:
The application of topical sildenafil cream led to improved outcomes among women diagnosed with female sexual arousal disorder, especially those not experiencing concomitant orgasmic dysfunction. The exploratory analysis highlighted that the use of topical sildenafil cream notably enhanced sexual arousal sensation, desire, and orgasm while reducing sexual distress.
CLINICAL TRIAL REGISTRATION:
ClinicalTrials.gov, NCT04948151.
Female sexual arousal disorder is defined by a persistent or recurring inability to achieve or maintain adequate lubrication-swelling responses during sexual activities, resulting in marked distress or interpersonal difficulties.1,2 Despite a high prevalence of this condition (approximately 20% of women in the U.S.3–5), no FDA-approved pharmacological treatments currently exist.
The formulation of topical sildenafil cream at a concentration of 3.6% was designed to address this condition directly. Prior research indicates that it may alleviate symptoms by enhancing blood flow to genital tissues, paralleling the action of oral sildenafil citrate (Viagra) in treating male erectile dysfunction.
METHODS
This study was conducted across 49 sites in the U.S., receiving approval from the Advarra Institutional Review Board (Pro00049161), and was registered at ClinicalTrials.gov (NCT04948151). Healthy premenopausal women aged 18 years or older and their sexual partners were screened for eligibility. Written informed consent was obtained from both volunteers and their sexual partners prior to any study-related activities.
The co-primary efficacy endpoints were determined by validated questionnaires including the SFQ28 (Sexual Function Questionnaire) and FSDS-DAO (Female Sexual Distress Scale—Desire, Arousal, Orgasm). A significant emphasis was placed on conducting a one-on-one clinical interview to ensure a precise diagnosis of female sexual arousal disorder.
RESULTS
Out of 833 volunteers screened, 200 women were randomized to receive either the sildenafil cream (n=101) or placebo cream (n=99). Analysis revealed that, although the sildenafil cohort displayed a positive trend in Arousal Sensation scores, these results lacked statistical significance across the entire population, which included individuals with various concomitant sexual dysfunction diagnoses.
Importantly, in an exploratory post hoc analysis, women solely diagnosed with female sexual arousal disorder or those with concomitant decreased desire showed substantial enhancements when utilizing the sildenafil cream compared to subjects receiving placebo cream.
Fig. 1. Disposition of participants.
Fig. 1.
Johnson. Sildenafil Cream for Female Sexual Arousal Disorder. Obstet Gynecol 2024.
DISCUSSION
The results imply that while topical sildenafil cream did not exhibit universal efficacy among all participants, it may offer significant benefits to certain subgroups. Women suffering from female sexual arousal disorder without concomitant orgasmic dysfunction demonstrated notable improvements in sexual function metrics.
The urgency for this study stems from the current lack of FDA-approved treatments available for female sexual arousal disorder. The exploratory nature of this research opens avenues for continuous investigation into the application of sildenafil cream for affected women, spotlighting variability in treatment responses.
Future investigations are necessary, particularly concentrating on identifying patients who might derive the most benefit from topical sildenafil cream, potentially leading to more effective and tailored interventions for female sexual arousal disorder.