At a glance

What it is

What topical sildenafil cream is and how it works

Female sexual arousal disorder (FSAD) is a persistent or recurring difficulty with the physical response of arousal, such as swelling, lubrication and sensation, that causes personal distress. In DSM-5, the American Psychiatric Association’s diagnostic manual, FSAD and low desire (HSDD) were merged into one diagnosis, female sexual interest/arousal disorder (FSIAD). Many clinicians and most trials still use FSAD, so this page uses both terms. Researchers still debate how well the DSM-5 categories match what women experience.

Sildenafil blocks an enzyme called PDE5. During arousal the body releases nitric oxide, which raises a messenger molecule called cGMP and relaxes smooth muscle in blood vessels. PDE5 breaks cGMP down. Blocking PDE5 lets the nitric oxide signal last longer, and blood flow to the tissue can increase. The same pathway drives erections in men.

A cream is meant to act where it is applied, with less reaching the rest of the body than a tablet. Whether it works in practice is what the trials below try to answer. Sildenafil does not replace estrogen or any other hormone. If low estrogen is part of the problem, see estradiol.

Who it is for

Who might consider it, and who should not

The women studied with topical sildenafil had a diagnosis of FSAD and were otherwise healthy. A physician evaluation comes first, because arousal problems have many causes, including low estrogen, medicines, pain with sex, and stress.

A physician may consider it for

• Women, premenopausal or postmenopausal, with distressing arousal difficulty and no more treatable cause found
• Women who take no nitrates and have no condition that makes a drop in blood pressure risky

It is not for

• Anyone using nitrates in any form, or riociguat
• Women who are pregnant, breastfeeding or trying to conceive
• Women with known sensitivity to sildenafil, or heart or blood pressure conditions a physician has not reviewed
• Women whose main problem is low desire or pain, where it is likely the wrong tool

Some medicines lower arousal and desire, including some antidepressants. Dr. Miranda reviews your medication list first.

Approval status

What FDA-approved means here, and what it does not

Sildenafil is FDA-approved only as oral tablets. Viagra is approved for erectile dysfunction. Revatio is approved for pulmonary arterial hypertension. No sildenafil cream or other topical product is FDA-approved, and no sildenafil product is FDA-approved for FSAD.

That makes this use off-label. A physician may prescribe an approved drug for an unapproved use when it is medically reasonable, and Dr. Miranda tells you plainly that this is what is happening.

Evidence

What the trials show

The evidence is limited and the results are mixed. The trials differ in population, product and endpoint, so they cannot be compared directly. Individual results vary.

Sildenafil cream 3.6% is investigational. The phase 2b trial is registered on ClinicalTrials.gov (NCT04948151) with Strategic Science & Technologies, LLC as sponsor and Daré Bioscience, Inc. listed as a collaborator. No sildenafil cream has been approved by FDA, and no trial result on this page shows that it works.

Topical sildenafil trials

• Phase 2b randomized trial, 2024. A 3.6% sildenafil cream was tested against placebo cream for 12 weeks in 200 premenopausal women with FSAD (101 sildenafil, 99 placebo). The cream group improved more on arousal sensation, but the difference was not statistically significant on either primary endpoint. A post hoc subset, women with FSAD with or without low desire, did show a significant gain. A post hoc result is a lead for the next trial, not a finding. (Johnson et al., Obstet Gynecol 2024.)
• Safety analysis of that trial. The most common treatment-related event was application site discomfort. Adverse events were reported by 29 of 99 women on sildenafil and 28 of 94 on placebo, all mild or moderate. (Thurman et al., J Sex Med 2024.)
• Phase 1 study in postmenopausal women, 2026. Twenty-one healthy women, mean age 57, received single doses. It measured safety and blood levels, not whether the cream works. All events were mild. The authors reported blood levels about two orders of magnitude lower than after a 100 mg tablet in men. (Cornell et al., Menopause 2026.)

Earlier oral sildenafil work

The first tests in women used tablets, and their results conflict.

• Berman pilot, 2001. Forty-eight women took 100 mg and improved compared with their own baseline. With no placebo group, it cannot show the drug caused the change. (Berman et al., J Sex Marital Ther 2001.)
• Berman placebo-controlled trial, 2003. In 202 postmenopausal women with FSAD, 12 weeks of oral sildenafil improved two primary items (p=0.017 and p=0.015). The benefit was in women without low desire. (Berman et al., J Urol 2003.)
• Basson trial, 2002. In 577 estrogenized and 204 estrogen-deficient women, sildenafil did not differ from placebo on any efficacy measure. (Basson et al., J Womens Health Gend Based Med 2002.)
• MRI crossover study, 2012. In 19 premenopausal women with FSAD, sildenafil added nothing to the clitoral engorgement seen with placebo. The authors suggested FSAD is not mainly a blood flow problem. (Leddy et al., J Sex Med 2012.)

A 2016 review of 14 randomized trials of PDE5 inhibitors in women found gains in some studies and negative results in others. (Gao et al., Int J Gynaecol Obstet 2016.) We found no topical sildenafil trial from the early 2000s that we could verify, so none is described.

How it is used

How the cream is applied

The cream is applied to the genital skin before sexual activity. The exact strength, amount and timing come from the prescription and the pharmacy label, not from this page. No FDA label exists for it.

For context only, the ClinicalTrials.gov record describes 2-gram applications up to 9 times per month in the phase 2b trial. The phase 1 study tested single doses of 50, 100 and 200 mg of sildenafil citrate in one investigational cream, and the 100 mg dose went into the phase 2b trial. Those are research doses, not a recommendation for a compounded product.

Safety

Side effects, interactions and precautions

Side effects

• Burning, stinging or discomfort where it is applied. In the safety trial, 4 women on sildenafil and 3 on placebo stopped because of it.
• Headache and flushing, the usual effects of sildenafil by mouth, reported more often on active drug in the oral trials
• Nasal stuffiness, nausea and visual changes, mainly with tablets

Stop the cream and call if you have a rash, swelling, severe burning or a sudden change in vision.

Systemic absorption

Some drug does reach the bloodstream. In the phase 1 study the peak level after the highest dose was far below the level after a tablet, with no cardiac events or symptomatic low blood pressure. That was 21 women given single doses of one cream, and it does not show a compounded cream behaves the same way.

Partners, condoms and pregnancy

In the safety trial, 7 of 91 partners exposed to the sildenafil cream reported 9 events, and 4 of 84 partners exposed to placebo cream reported 4. The trial was not powered to compare these. Ask Dr. Miranda about partner contact. We could not verify whether the cream is compatible with latex condoms, so ask the pharmacy about the base.

The sildenafil label says it is not indicated for use in females and that there are no data on use in pregnant women. Limited data show it in breast milk. Do not use the cream while pregnant or breastfeeding unless your physician has weighed that with you.

Compared with other options

How it differs from Vyleesi, estradiol and oral sildenafil

These are not interchangeable. Which one fits depends on whether the problem is desire, arousal, hormones or pain. See also perimenopause, muscle and bones and hormone therapy for women.

Other options

Other options for arousal and desire problems

No FDA-approved drug is designated specifically for arousal disorder. The approved drugs are for low desire.

• FDA-approved, for desire. Addyi (flibanserin), a tablet for women under 65 with acquired, generalized low desire, and Vyleesi (bremelanotide), an as-needed injection for premenopausal women. See Addyi and Vyleesi.
• Off-label. Vaginal estrogen, which helps when menopause changes cause dryness or pain. See estradiol. Low-dose testosterone gel after menopause, covered by a clinical practice guideline for low desire. Bupropion, buspirone or trazodone, mainly when an SSRI is lowering sexual response.
• Investigational. Sildenafil cream 3.6%, the product this page describes. It is not approved.
• Non-drug care. Cognitive behavioral therapy, sex therapy, pelvic floor physical therapy, and a review of your current medicines, SSRIs in particular.

Off-label means the use is not in the FDA label. Dr. Miranda tells you plainly when that applies, and the physician decides what fits.

Summit’s role

What Summit does with sildenafil cream

Dr. Miranda decides whether this fits you after your history and labs. If he prescribes it, it is prepared for you by an independent, state-licensed pharmacy as a named patient. Summit does not dispense or sell it and keeps no stock in the office.

Nothing on this page promises a prescription. If sildenafil cream does not fit, you will hear why. See pricing for what the program includes, and hormone therapy if your symptoms point that direction.

Keep reading

Related medications

Sources

Where this comes from

All retrieved November 10, 2026.

1. Johnson et al. Preliminary Efficacy of Topical Sildenafil Cream for the Treatment of Female Sexual Arousal Disorder: A Randomized Controlled Trial. Obstet Gynecol 2024. https://pubmed.ncbi.nlm.nih.gov/38889431/
2. Thurman et al. Safety of topical sildenafil cream, 3.6% in a randomized, placebo-controlled trial for the treatment of female sexual arousal disorder. J Sex Med 2024. https://pubmed.ncbi.nlm.nih.gov/39079074/
3. Johnson et al. Impact of age, race, and medication use on efficacy endpoints in a randomized controlled trial of topical sildenafil cream for female sexual arousal disorder. Sex Med 2024. https://pubmed.ncbi.nlm.nih.gov/39564518/
4. Cornell et al. A phase 1, open-label, within-participant dose-escalation study of topical sildenafil cream in healthy postmenopausal women. Menopause 2026. https://pubmed.ncbi.nlm.nih.gov/42639865/
5. Berman et al. Safety and efficacy of sildenafil citrate for the treatment of female sexual arousal disorder: a double-blind, placebo controlled study. J Urol 2003. https://pubmed.ncbi.nlm.nih.gov/14634409/
6. Berman et al. Effect of sildenafil on subjective and physiologic parameters of the female sexual response in women with sexual arousal disorder. J Sex Marital Ther 2001. https://pubmed.ncbi.nlm.nih.gov/11554201/
7. Basson et al. Efficacy and safety of sildenafil citrate in women with sexual dysfunction associated with female sexual arousal disorder. J Womens Health Gend Based Med 2002. https://pubmed.ncbi.nlm.nih.gov/12150499/
8. Leddy et al. Influence of sildenafil on genital engorgement in women with female sexual arousal disorder. J Sex Med 2012. https://pubmed.ncbi.nlm.nih.gov/22620487/
9. Gao et al. Systematic review and meta-analysis of phosphodiesterase type 5 inhibitors for the treatment of female sexual dysfunction. Int J Gynaecol Obstet 2016. https://pubmed.ncbi.nlm.nih.gov/26797204/
10. VIAGRA (sildenafil citrate) prescribing information. DailyMed, U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=0b0be196-0c62-461c-94f4-9a35339b4501
11. REVATIO (sildenafil citrate) prescribing information. DailyMed, U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=3bb9363e-b28d-4019-8aae-539233dca214
12. Compounding and the FDA: Questions and Answers. U.S. Food and Drug Administration. https://www.fda.gov/drugs/human-drug-compounding/compounding-and-fda-questions-and-answers
13. ClinicalTrials.gov NCT04948151. Phase 2b study of sildenafil cream, 3.6% in premenopausal patients with female sexual arousal disorder. U.S. National Library of Medicine. https://clinicaltrials.gov/study/NCT04948151
14. ADDYI (flibanserin) prescribing information. DailyMed, U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=3819daf3-e935-2c53-c527-e1d57922f394
15. VYLEESI (bremelanotide injection) prescribing information. DailyMed, U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=f1d0c1b5-2f39-4bad-a6a4-0066e3ad5dcf
16. Do the DSM-5 criteria actually reflect the clinical reality of female sexual dysfunctions? J Sex Med 2025. https://pubmed.ncbi.nlm.nih.gov/40828112/
17. International Society for the Study of Women’s Sexual Health Clinical Practice Guideline for the Use of Systemic Testosterone for Hypoactive Sexual Desire Disorder in Women. J Sex Med 2021. https://pubmed.ncbi.nlm.nih.gov/33814355/