Sildenafil cream demonstrates safety, efficacy in phase 2b study for female sexual arousal disorder

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Some chronic conditions, such as diabetes or multiple sclerosis, can cause changes in arousal or orgasm. If you have trouble with sexual desire or response, talk with a member of your healthcare team. You might want to talk to a sex therapist. Medicines, hormones, creams, lubricants, clitoral stimulation or other treatments sometimes can help. There is a problem with information submitted for this request.

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Society and culture

These Italian authors conducted a randomized, double-blind, .. These Italian authors conducted a randomized, double-blind, crossover study to explore the use of sildenafil in 51 women (aged 22-38) with documented ovarian function who reported adequate sexual desire but decreased arousal. Subjects were recruited from a sexual dysfunction clinic; each had a lack of vaginal lubrication and a lack of clitoral and vaginal sensation or slow sexual response. The women received 4-week regimens of 25-mg sildenafil, 50-mg sildenafil, and placebo in random order, with a 1-week washout between treatments; each tablet was to be taken 1 hour before intercourse, not more than once daily… Given the success of medicines to treat trouble getting and keeping an erection, called erectile dysfunction, companies have looked for a medicine to help women with sex. Viagra even has been tried as a treatment for sexual dysfunction in women.

Mohamed Alhefnawy1*, Abdulla Esawy2, Mohamed Abdelazeem1, Mohamed Elnamoury3, Ahmed Eissa4, Ahmed Zoair4, Ahmed Ghaith4, Ayman Hagras4 and Khaled Almekaty4

But the U.S. Food and Drug Administration (FDA) hasn't approved this use of Viagra. For years there were no FDA-approved medicines for treating problems with sexual arousal or sexual desire in women. Yet 4 in 10 women report having sexual concerns. The FDA now has approved two medicines. You may opt out of email communications at any time by clicking on the unsubscribe link in the email.

Country	Legal Status	Prescription Required	Notes
USA	Approved for certain uses	Yes	Off-label for women often not approved
UK	Prescription-only	Yes	Approved for male ED; off-label use in women
Canada	Restricted use	Yes	Prescription required; variable by province
Australia	Prescription-only	Yes	Limited clinical guidelines for women

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What happens if a woman takes Viagra?

Although the sildenafil cream is manufactured “in an outsourcing facility subject to FDA inspection and under current Good Manufacturing Practice regulations,” Daré Bioscience noted that compounded drugs are not FDA approved or evaluated by the agency for “safety, effectiveness, or quality.”1 DARE to PLAY is currently available for prescription for pre-order in Connecticut, Florida, Indiana, Missouri, New Jersey, Oregon, Pennsylvania, Rhode Island, and Utah. Daré Bioscience said the sildenafil cream’s availability will expand to other states throughout December 2025 and early 2026.1 DARE to PLAY has been evaluated in several studies, including a phase 2b randomized controlled trial (NCT04948151), the results of which were published in Obstetrics & Gynecology. In that study, 200 women with female sexual arousal disorder (FSAD) were randomly assigned to receive the sildenafil cream or placebo cream. The co-primary efficacy end points included change from baseline to week 12 in the Arousal Sensation domain of the Sexual Function Questionnaire (SFQ28), as well as question 14 of the Female Sexual Distress Scale—Desire, Arousal, Orgasm (FSDS-DAO).2 Greater improvement in SFQ28 Arousal Sensation domain scores was observed in patients receiving sildenafil cream, although “there were no statistically significant differences between sildenafil and placebo cream users in the coprimary and secondary efficacy end points,” wrote the authors. The investigators also conducted an exploratory post hoc analysis evaluating a subset of the intention-to-treat population who had a diagnosis of FSDD with or without concomitant decreased desire.

Authors and Affiliations

In this subset, significant increases in SFQ28 Arousal Sensation domain score were seen vs the placebo group. These patients also had a higher mean improvement in SFQ28 Desire and Orgasm domain scores, as well as significantly decreased sexual distress and interpersonal difficulties as assessed by FSDS-DAO questions 3, 5, and 10.2 “As more women speak openly about their sexual health, the need for research-backed solutions has never been greater,” said Irwin Goldstein, MD, director of San Diego Sexual Medicine in California and a founder of the International Society for the Study of Women’s Sexual Health in the news release. “Daré’s commitment to both clinical integrity and timely access ensures women who need it don’t have to wait to benefit from this innovation.”1 DARE to PLAY sildenafil cream now available for pre-order by prescription: First evidence-based topical arousal cream for women begins commercial rollout in select states via 503B outsourcing facility. Preliminary efficacy of topical sildenafil cream for the treatment of female sexual arousal disorder: A randomized controlled trial. Sildenafil is a standard treatment for male erectile dysfunction, but its application in female sexual dysfunction remains uncertain. American Association for Marriage and Family Therapy.

• Female sexual dysfunction affects millions worldwide, prompting research into treatments.
• Sildenafil is part of a broader conversation about women’s sexual health innovations.
• The role of sildenafil in improving orgasm quality is still being studied.
• It is essential to distinguish between clinical trial results and off-label use.
• Some women experience mood improvement alongside physical effects with sildenafil.
• Education about both benefits and risks is crucial for women considering sildenafil.

Overview of sexual dysfunction in women: Management.

Parameter	Description	Typical Values	Notes
Absorption Rate	Time to reach peak plasma levels	30-120 minutes	Varies with food intake
Half-Life	Duration of drug activity	4 hours	Metabolized mainly in liver
Bioavailability	Percentage of drug absorbed	40-50%	Affected by gastric pH
Metabolism	Enzymes involved	CYP3A4	Liver metabolism mainly
Excretion	How drug is eliminated	Feces and urine	Mainly fecal excretion

Viagra is sometimes prescribed to treat female sexual arousal disorder, but its effectiveness is still unclear.

Chemical synthesis

Headache, flushing, dyspepsia, nasal congestion, and transient visual disturbances were the most common adverse events reported with sildenafil use in this study; nausea and increased anxiety were more commonly reported in the placebo group than the study group. This is the first randomized placebo-controlled study to show a significant decrease in sexual side effects when looking at the use of sildenafil in premenopausal women with SSRI-associated sexual dysfunction, supporting previous case reports and open label studies of this medication in this population. Nurnberg HG, Hensley PL, Heiman JR, Croft HA, Debattista C, Paine S. Sildenafil Treatment of Women with Antidepressant-Associated Sexual Dysfunction. DARE to PLAY is a topical sildenafil cream enhancing female arousal, available in select states as a compounded product while awaiting FDA approval.

Statistical Analysis

Clinical trials showed improved arousal sensation scores, though not statistically significant compared to placebo, with significant benefits in a subset of women with FSAD. Daré Bioscience said the sildenafil cream’s availability will expand to other states throughout December 2025 and early 2026. DARE to PLAY, a proprietary topical arousal cream designed to enhance genital blood flow and arousal response in women, can now be prescribed in select states, manufacturer Daré Bioscience, Inc announced in a news release.1 “When Viagra [sildenafil citrate] was approved in 1998, it revolutionized sexual medicine for men. But for women, comparable progress on enhancing the natural arousal sensations has stalled for nearly 3 decades,” said Sabrina Martucci Johnson, President and CEO of Daré Bioscience, in the news release. “We believe DARE to PLAY represents a long overdue correction, giving women an option to reconnect with their own bodies, their pleasure, and their confidence, using science that finally recognizes their needs.”1 As the company continues the process to seek FDA approval of the sildenafil cream formulation, it is making the cream available in the form of a Section 503B compounded product. If a woman takes Viagra, it might help increase blood flow to the genitals, which could increase sensitivity and arousal. While some studies show Viagra might work for female sexual dysfunction, more research is needed to know for sure.

• 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.

When a woman takes Viagra, it may increase blood flow to her genitals, potentially enhancing

• Awareness of sildenafil's potential side effects helps women make informed choices.
• Women should avoid using sildenafil with nitrates to prevent dangerous drops in blood pressure.
• Proper diagnosis of sexual dysfunction can guide appropriate treatment options.
• Scientific research continues to explore safer, women-specific sexual health drugs.
• Sildenafil’s long-term effects on women are not yet fully understood.
• Healthcare providers can help determine if sildenafil is appropriate for individual cases.

sensitivity and arousal, though its effectiveness is still inconclusive and it's not FDA-approved for this purpose.

DARE to PLAY Sildenafil Cream

It should not be used more than once a day or more than eight times a month. Side effects can include nausea, headache, vomiting and reactions at the site of the shot. Talk with your healthcare professional to see if this medicine might be right for you. Sexual problems may be due to trouble with arousal, a lack of desire or both. Many factors can affect sexual desire in women.

Cite this article

Many women find that the stresses of daily life lower their desire for sex. Highs and lows in sexual desire may go along with the beginning or end of a relationship or with major life changes, such as pregnancy or menopause. For sildenafil generic some women, orgasm can be hard to reach. This can cause worries that lead to a loss of interest in sex. Desire often is linked to a sense of closeness between partners, as well as sexual issues from the past. While generally safe, mild side effects can occur, and other more effective treatments for female sexual arousal disorder exist.

• Clinical research into sildenafil for women includes various dosage trials.
• Women using sildenafil should monitor blood pressure to avoid adverse effects.
• The safety profile of sildenafil in women is less documented than in men.
• Sildenafil’s impact on female sexual desire is still under scientific investigation.
• Women should avoid sildenafil if pregnant or breastfeeding unless prescribed.
• Alternative therapies for female sexual dysfunction include counseling and hormone therapy.

Evidence is limited regarding the benefits of Viagra (sildenafil) for females with sexual dysfunction.

Non-medical use

The FDA sildenafil 200 mg has approved a daily pill called flibanserin (Addyi) to treat low sexual desire in women before menopause. This medicine started as a treatment for depression. Addyi may boost sex drive in women with low sexual desire. It's for women who are not happy with their low sex drive. Possible serious side effects include low blood pressure, dizziness and fainting.

Marketing and sales

These side effects are more likely to happen if the medicine is mixed with alcohol. The FDA says not to drink alcohol if you take this medicine. Experts suggest that you stop taking the medicine if your sex drive doesn't improve after eight weeks. The FDA also has approved a medicine given as a shot to treat low sexual desire in women before menopause. Bremelanotide (Vyleesi) is injected under the skin in the belly or thigh at least 45 minutes before having sex.