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Participants applied the investigational product about

Medication Type	Interaction Effect	Risk Level	Notes
Nitrates	Severe hypotension	High	Contraindicated
Alpha-Blockers	Increased risk of hypotension	Moderate	Dose adjustment may be needed
CYP3A4 Inhibitors	Increased sildenafil levels	Moderate to high	Watch for adverse effects
CYP3A4 Inducers	Decreased effectiveness	Moderate	Alternative treatments considered

10–20 minutes before the sexual event.

Author information

The study was conducted under a U.S. Food and Drug Administration–approved investigational new drug application. Each author has confirmed compliance with the journal's requirements for authorship. This is an open access article distributed under the terms of the Creative Commons Attribution-Non Commercial-No Derivatives License 4.0 (CCBY-NC-ND), where it is permissible to download and share the work provided it is properly cited. The work cannot be changed in any way or used commercially without permission from the journal.

What side effects can low dose sildenafil cause?

To assess the efficacy of topical sildenafil cream, 3.6% among healthy premenopausal women with female sexual arousal disorder. We conducted a phase 2b, exploratory, randomized, placebo-controlled, double-blind study of sildenafil cream. Coprimary efficacy endpoints were the change 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). Two hundred women with female sexual arousal disorder were randomized to sildenafil cream (n=101) or placebo cream (n=99). A total of 174 participants completed the study (sildenafil 90, placebo 84). One gram was applied externally to the anterior labial commissure,

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prepuce of the clitoris, glans, frenulum, vestibule, and labia minora.

What are the potential side effects of Viagra for women?

The coprimary efficacy endpoints were the change from baseline to week 12 in the Arousal Sensation domain of the SFQ38 (Sexual Function Questionnaire) and question 14 of the FSDS-DAO (Female Sexual Distress Scale—Desire, Arousal, Orgasm). A one-on-one clinical interview was conducted with each potential participant, using interviewers who were not employees of the study sponsor and who were recognized experts in the field, to establish the diagnosis of female sexual arousal disorder and to verify that female sexual arousal disorder was the woman's main sexual dysfunction concern if other concomitant sexual dysfunction diagnoses or symptoms existed. The clinical interview documented those concomitant diagnoses or symptoms for exploratory post hoc analyses based on sexual dysfunction diagnoses or symptoms at enrollment. The first screening occurred in July 2021, and the last participant visit was in April 2023. Appendix 1, available online at outlines the schedule of efficacy evaluations.

A note about sex and gender

In brief, volunteers underwent informed consent and screening safety procedures at visit 1. A major barrier to recruitment was the requirement for sexual partners to be consented and involved in adverse event reporting because many volunteers did not want to disclose their female sexual arousal disorder symptoms to their sexual partners. Therefore, amendment 3 of the protocol allowed women to enroll in the trial if they did not have a sexual partner or if their sexual partner did not want to participate in the informed consent and safety monitoring process. In this latter case, investigational product was used only for unpartnered sexual events. As shown in Appendix 1 ( the study included a 28-day no-drug run-in period starting at visit 2, followed by a 28-day single-blind placebo run-in period beginning at visit 3. The other gram was applied to the anterior

We got busy with a full clinical study.

Cornell is an employee of Strategic Science & Technologies, LLC. She indicated that this article discusses off-label use, in that sildenafil cream for FSAD is investigated. Clint Dart provided independent data verification and is an employee of Premier Research. C. Paige Brainard was the principal investigator of this study and was financially compensated by Del Sol Research Management for that service.

Raynaud's phenomenon

Dr. Brainard's practice received funding from Daré Bioscience for study specific activities. Dr. Goldstein also reported receiving payments from Nuvig, Ipsen, and AbbVie. This is a phase 2b study of topical sildenafil cream 3.6%, which is being developed clinically for the treatment of female sexual arousal disorder. distal vagina to an approximate depth of 0–3 cm

Ready to see why DARE to PLAY could be the best you've ever had?

Participants were randomized with a concealed, interactive response technology system, after the single-blind run-in period, to either sildenafil cream or placebo cream in a 1:1 ratio. The allocation was blinded, and there were no allocation errors. The placebo cream contained the same ingredients as the sildenafil cream but without the active ingredient, sildenafil citrate. Each month, the investigational product was dispensed in a 30-g tube, along with nine 2-g dosing cards. Participants were instructed to apply no more than one 2-g application of product per calendar day and no more than 9 applications per month. or about halfway between the distal and proximal interphalangeal

• Female patients should be cautious with sildenafil due to lack of approval.
• Erectile dysfunction medications can interact with other drugs, affecting women as well.
• Some studies suggest sildenafil may help women with arousal issues but are inconclusive.
• Sildenafil may improve clitoral blood flow, enhancing sensitivity.
• Libido enhancement from sildenafil varies based on individual health factors.
• Self-medicating women with sildenafil without supervision can be risky.

joints, targeting the distal, lower one-third of the vagina.

Where the Magic Happens

Female sexual arousal disorder is clinically analogous to male erectile dysfunction, characterized by impaired blood flow to genital tissues. Oral sildenafil citrate (Viagra) was approved in 1998 for the treatment of erectile dysfunction. Published placebo-controlled trials of oral sildenafil administered in premenopausal and postmenopausal women afflicted with broad-spectrum female sexual dysfunction (eg, hypoactive sexual desire disorder, female sexual arousal disorder, female orgasmic disorder, dyspareunia) demonstrated marginal efficacy compared with placebo6–9 with high incidences of intolerable side effects. Topical sildenafil cream 3.6% (sildenafil cream) has been developed for the treatment of female sexual arousal disorder. We hypothesized that by delivering sildenafil citrate topically with a fast-absorbing delivery technology specifically targeting genital anatomy central to the vascular arousal response,10 there would be less systemic exposure, fewer systemic side effects, and a more immediate biological efficacy response.

Exploratory Phase 2b RESPOND Study, Completed in 2023

Before the start of the study, we conducted a qualitative content validity study among women with female sexual arousal disorder to ensure that the efficacy endpoints, which were patient-reported outcome measures, were fit for purpose and valid for this specific population.11 This clinical trial was conducted at 49 sites in the United States, approved by the Advarra IRB (Pro00049161), and registered at ClinicalTrials.gov (NCT04948151). Healthy premenopausal women aged 18 years or older and their sexual partners were screened for the study. Volunteers and their sexual partners provided written informed consent before the performance of any study-related procedures. Women at risk of pregnancy used effective contraception during the study (eg, hormonal contraception). Male condoms sildenafil 60mg could be used for sexually transmitted infection prevention. Participants were instructed to wash off the cream and have their

• Sildenafil may help women with conditions like arousal disorder, but evidence varies.
• There is ongoing research into safe, effective female-specific doses of sildenafil.
• Side effects experienced by women can include dizziness, nausea, or visual disturbances.
• Consumption of alcohol while on sildenafil can increase side effect risks.
• Female sexual dysfunction can have psychological, hormonal, and physical causes.
• Sildenafil is not a cure-all; proper diagnosis is important for targeted treatment.

partner wash off the cream, if relevant, after the sexual experience.

Is Viagra an Option for Female Sexual Dysfunction?

Among the intention-to-treat (ITT) population, which included women with only female sexual arousal disorder and those with female sexual arousal disorder with concomitant sexual dysfunction diagnoses or genital pain, although the sildenafil cream group demonstrated greater improvement in the SFQ28 Arousal Sensation domain scores, there were no statistically significant differences between sildenafil and placebo cream users in the coprimary and secondary efficacy endpoints. An exploratory post hoc subset of the ITT population with an enrollment diagnosis of female sexual arousal disorder with or without concomitant decreased desire randomized to sildenafil cream reported significant increases in their SFQ28 Arousal Sensation domain score (least squares mean 2.03 [SE 0.62]) compared with placebo cream (least squares mean 0.08 [SE 0.71], P=.04). This subset achieved a larger mean improvement in the SFQ28 Desire and Orgasm domain scores. This subset population also had significantly reduced sexual distress and interpersonal difficulties with sildenafil cream use as measured by FSDS-DAO questions 3, 5, and 10 (all P≤.04). Topical sildenafil cream improved outcomes among women with female sexual arousal disorder, most significantly in those who did not have concomitant orgasmic dysfunction.

Interactions with other medications

In particular, in an exploratory analysis of a subset of women with female sexual arousal disorder with or without concomitant decreased desire, topical sildenafil cream increased sexual arousal sensation, desire, and orgasm and reduced sexual distress. Topical sildenafil cream 3.6% improved outcomes among women with female sexual arousal disorder, particularly an exploratory subset of women with female sexual arousal disorder with or without concomitant decreased desire. Female sexual arousal disorder is a persistent or recurrent inability to attain, or to maintain until completion of the sexual activity, an adequate lubrication-swelling response of sexual excitement that causes marked distress or interpersonal difficulty.1,2 Despite the high prevalence of female sexual arousal disorder (about 20% of U.S. women3–5), to date there are no U.S. Food and Drug Administration (FDA)–approved pharmacologic treatments for female sexual arousal disorder. The Arousal Sensation domain of the SFQ28 questionnaire is made up

What special precautions should I follow?

Participants were screen failed during these 2 months if they were not compliant with recording sexual events, adverse events, or concomitant medications in the daily electronic diary or if they had a predetermined placebo response during the single-blind run-in period. Eligible participants were randomized at visit 4 in a 1:1 manner to sildenafil cream or placebo cream. The double-blind dosing period lasted 12 weeks, and responses at visit 4 and electronic diary data from the single-blind placebo run-in period were baseline scores. Participants were seen monthly during the double-blind dosing period at weeks 4 (visit 5), 8 (visit 6), and 12 (visit 7) and answered the 1-month recall SFQ28 and FSDS-DAO surveys. Participants recorded data in the electronic diary within 24 hours of a sexual event between monthly appointments. of questions 6 through 9 (Appendix 2, available online at These

• 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.

four questions were answered using a Likert scale ranging from 1–5,

• Some women seek sildenafil for increasing genital blood flow and sensation.
• The placebo effect can influence perceived benefits in women using sildenafil.
• Women with cardiovascular risk should avoid sildenafil unless approved by a doctor.
• Topical or alternative therapies might be considered alongside or instead of sildenafil.
• Scientific consensus on sildenafil’s safety for women remains under development.
• Proper dosing and medical oversight are key to minimizing risks.

with 1 being no sensation and 5 being a very strong sensation.