Beyond Men: Viagra Cream for Female Sexual Arousal Disorder and Its Psychological Benefits

Further, data from a thermography study in healthy women demonstrated significantly greater increases in genital temperature after administration of Sildenafil Cream compared to placebo cream, indicating a positive impact on genital blood flow during the 30-minute testing session, with statistical separation from placebo within the first 15 minutes after dosing. We also completed a content validity study designed to identify and document the genital arousal symptoms that are the most important and relevant to women with FSAD.

• Viagra cream is a topical treatment designed for erectile dysfunction.
• It contains the active ingredient sildenafil.
• Applied directly to the skin for quick absorption.
• Typically used before sexual activity for increased blood flow.
• Often marketed as an alternative to oral tablets.
• May have fewer systemic side effects than pills.
• Application areas usually include the inner thigh or genitals.
• Effectiveness can vary depending on individual response.
• Needs to be applied about 15-30 minutes prior to sex.
• Not suitable for people allergic to sildenafil or similar drugs.

The findings of this study helped facilitate alignment with the FDA on acceptable efficacy endpoints for the Phase 2b RESPOND study and a future Phase 3 program.

Menopause Care Made Easy

The Phase 2b study was an exploratory study to evaluate a number of primary endpoints and secondary endpoints as well as to identify a target patient population for Sildenafil Cream, 3.6%. The Phase 2b clinical study was designed as a multi-center, double-blind, placebo-controlled study to evaluate the efficacy and safety of Sildenafil Cream, 3.6% in premenopausal patients with female sexual arousal disorder (FSAD). Study participants used Sildenafil Cream and placebo cream over 12 weeks in their home setting, following both a non-drug and placebo cream run-in period. All participants had a main diagnosis of FSAD and may have also had concomitant sexual dysfunction diagnoses or symptoms including decreased desire, orgasmic dysfunction, and genital pain. Exploratory Phase 2b clinical study designed to evaluate Sildenafil Cream vs. placebo over 12 weeks of double-blinded dosing following both a non-drug and placebo run-in period: Compared Sildenafil Cream vs.

Product	Dosage	Quantity + Bonus	Price
Viagra Oral Jelly	100mg	21 Sachets	78.66€ 74.91€	Buy
Viagra Generic	25mg	30 + 4 Pills	47.97€ 45.69€	Buy
Viagra Soft Tabs	100mg	90 + 6 Pills	205.31€ 195.53€	Buy
Viagra Generic	50mg	30 + 4 Pills	54.26€ 51.68€	Buy
Viagra Generic	50mg	90 + 6 Pills	107.37€ 102.26€	Buy
Viagra Original	100mg	4 Pills	40.94€ 38.99€	Buy
Viagra Generic	50mg	180 + 8 Pills	158.82€ 151.26€	Buy
Viagra Oral Jelly	100mg	10 Sachets	46.36€ 44.15€	Buy
Viagra Generic	200mg	90 + 6 Pills	170.79€ 162.66€	Buy
Viagra Generic	25mg	180 + 6 Pills	154.93€ 147.55€	Buy
Viagra Generic	100mg	180 + 8 Pills	199.37€ 189.88€	Buy
Viagra Original	100mg	64 + 4 Pills	264.15€ 251.57€	Buy
Viagra Generic	50mg	20 Pills	40.52€ 38.59€	Buy
Viagra Original	100mg	76 + 4 Pills	306.59€ 291.99€	Buy
Viagra Generic	150mg	60 + 4 Pills	111.25€ 105.95€	Buy

placebo used in patients’ home setting.

HOW TO GET YOUR PRESCRIPTION

Further, data from a thermography study in healthy women demonstrated significantly greater increases in genital temperature after administration of Sildenafil Cream compared to placebo cream, indicating a positive impact on genital blood flow during the 30-minute testing session, with statistical separation from placebo within the first 15 minutes after dosing. We also completed a content validity study designed to identify and document the genital arousal symptoms that are the most important and relevant to women with FSAD. The findings of this study helped facilitate alignment with the FDA on acceptable efficacy endpoints for the Phase 2b RESPOND study and a future Phase 3 program. The Phase 2b study was an exploratory study to evaluate a number of primary endpoints and secondary endpoints as well as to identify a target patient population for Sildenafil Cream, 3.6%. The Phase 2b clinical study was designed as a multi-center, double-blind, placebo-controlled study to evaluate the efficacy and safety of Sildenafil Cream, 3.6% in premenopausal patients with female sexual arousal disorder (FSAD).

Why is clitoral stimulation for orgasm more important during menopause?

Study participants used Sildenafil Cream and placebo cream over 12 weeks in their home setting, following both a non-drug and placebo cream run-in period. All participants had a main diagnosis of FSAD and may have also had concomitant sexual dysfunction diagnoses or symptoms including decreased desire, orgasmic dysfunction, and genital pain. Exploratory Phase 2b clinical study designed to evaluate Sildenafil Cream vs. placebo over 12 weeks of double-blinded dosing following both a non-drug and placebo run-in period: Compared Sildenafil Cream vs. placebo used in patients’ home setting.

Sildenafil and lipolysis

Co-primary endpoints: patient reported outcome (PRO) instruments measured improvement in localized genital sensations of arousal (Arousal-Sensation Domain of the Sexual Function Questionnaire) and reduction in FSAD related distress (Female Sexual Distress Scale). Secondary endpoint: measured change in the number of satisfactory sexual events Exploratory endpoints: Several efficacy endpoints measured and could be candidate endpoints in a Phase 3 study. Efficacy assessments were administered both on an electronic diary to be completed within 24 hours of a sexual event and via 28-day recall assessments. Sildenafil Cream-treated group showed meaningful improvement in the co‑primary endpoint assessment that evaluated change from baseline in the Arousal-Sensation Domain of the Sexual Function Questionnaire, although the endpoint did not achieve statistical significance.1 Post-hoc analyses showed that Sildenafil Cream met the Ph2b co-primary endpoint (SFQ28-arousal domain patient reported outcome (PRO)) and demonstrated clinically meaningful benefit in patients who have FSAD or FSAD with concomitant decreased desire. Secondary and exploratory endpoints saw these patients report meaningful improvement in arousal sensation, desire, orgasm, as well as stress, guilt, and embarrassment about the sexual dysfunction. Co-primary endpoints: patient reported outcome (PRO) instruments measured improvement in localized genital sensations of arousal (Arousal-Sensation Domain of the Sexual Function Questionnaire) and reduction in FSAD related distress (Female Sexual Distress Scale). Secondary endpoint: measured change in the number of satisfactory sexual events Exploratory endpoints: Several efficacy endpoints measured and could be candidate endpoints in a Phase 3 study. Efficacy assessments were administered both on an electronic diary to be completed within 24 hours of a sexual event and via 28-day recall assessments. Sildenafil Cream-treated group showed meaningful improvement in the co‑primary endpoint assessment that evaluated change from baseline in the Arousal-Sensation Domain of the Sexual Function Questionnaire, although the endpoint did not achieve statistical significance.1 Post-hoc analyses showed that Sildenafil Cream met the Ph2b co-primary endpoint (SFQ28-arousal domain patient reported outcome (PRO)) and demonstrated clinically meaningful benefit in patients who have FSAD or FSAD with concomitant decreased desire.

Medication Type	Interaction Effect	Advice
Nitrates	Severe hypotension (low blood pressure)	Avoid concurrent use
Alpha-blockers	Enhanced blood pressure-lowering effect	Monitor blood pressure
CYP3A4 Inhibitors	Increased plasma levels of sildenafil	Dose adjustment needed

Secondary and exploratory endpoints saw these patients report meaningful improvement in arousal sensation, desire, orgasm, as well as stress, guilt, and embarrassment about the sexual dysfunction. Read more about the Phase 2b clinical study here. Regulatory Strategy for Sildenafil Cream, 3.6%: Next Steps The Company is working to align with the FDA on the Phase 3 study design. At the conclusion of the development program, if successful, Daré intends to leverage the existing safety and efficacy data for sildenafil to utilize the FDA’s 505(b)(2) pathway to obtain marketing approval of Sildenafil Cream, 3.6% for the treatment of women in the U.S. DOI: 10.1016/j.sxmr.2016.03.002 Ad Hoc Market Research: FSAD Prevalence Report (Oct 2015) conducted for SST LLC. Based on US Census projections for 2016. Dare Bioscience developed Dare to Play, a cream boosting female sexual arousal in 10 minutes The cream contains sildenafil, the active ingredient in Viagra, increasing vaginal blood flow Clinical trials showed Dare to Play improved libido and orgasms with no side effects versus placebo Over three decades after the invention of Viagra, a little blue pill that allows men to boost their sexual performance, scientists have developed a similar alternative for women.

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

Johnson said the new cream represents a "long overdue correction" that allows women an option to reconnect with their own bodies, with science finally recognising their needs as well. As for why a pill akin to those used by men was not developed, Johnson said a female pill viagra tablet for sex would require a lot of sildenafil. She added that the option was "just not practical" as it would require much higher doses than what men generally need. Residents of Connecticut, Florida, Indiana, Missouri, New Hampshire, New Jersey, Oregon, Pennsylvania, Rhode Island and Utah can pre-order the cream already. Track Latest News Live on NDTV.com and get news updates from India and around the world Developed and evaluated specifically for women, DARE to PLAY™ Sildenafil Cream is a first-of-its-kind female arousal cream, a non-hormonal topical cream shown in clinical studies to increase genital blood flow in 10–15 minutes, and improve arousal sensations based on clinically-validated endpoints.

Key Takeaways

Market introduction of DARE to PLAY™ is expected to mark a breakthrough in women’s sexual health and represents important progress toward closing one of medicine’s most persistent gender gaps. SAN DIEGO, Dec. 10, 2025 (GLOBE NEWSWIRE) -- Daré Bioscience, Inc. (NASDAQ: DARE), a purpose-driven health biotech company solely focused on closing the gap in women’s health between promising science and real-world solutions, today announced that providers in select states can now begin prescribing DARE to PLAY™ Sildenafil Cream, a proprietary topical arousal cream designed specifically for women to enhance genital blood flow and arousal response. DARE to PLAY™ represents the first and only evidence-backed sildenafil cream formulation for women.

Can topical sildenafil improve sex?

Its commercial availability through a 503B outsourcing facility will mark the first time a topical sildenafil formulation manufactured in accordance with cGMP requirements and supported by clinical data will be accessible to women. DARE to PLAY™ uses sildenafil, the same active ingredient found in Viagra®, to improve genital blood flow. Applied topically, it’s designed for use as needed, to enhance the body’s natural arousal response without systemic effects, providing women with a new, evidence-based tool to take charge of their sexual health. “When Viagra 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 three decades,” said Sabrina Martucci Johnson, President and CEO of Daré Bioscience. US-based health biotech group Dare Bioscience has created a $10 a use product that works in just 10 minutes and boosts women's arousal.

References (14)

“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.” Existing products promoted for arousal lean heavily on marketing language, consumer reviews, and lifestyle branding without real evidence. DARE to PLAY™ is the first and only topical formulation of sildenafil developed specifically for women and backed by: Toxicology studies covering oral, anal, vaginal, and reproductive health; Multiple clinical trials in women, including a randomized placebo-controlled study with 200 women and their sexual partners; and Published, peer-reviewed research in medical journals such as The Green Journal, the official publication of the American College of Obstetrics and Gynecology (ACOG) and the Journal of Sexual Medicine, the official publication of the International Society for the Study of Women’s Sexual Health (ISSWSH). “As more women speak openly about their sexual health, the need for research-backed solutions has never been greater,” said Dr. Irwin Goldstein, Director of San Diego Sexual Medicine and a founder of ISSWSH. “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.” While continuing activities necessary to seek U.S.

MORE MENOPAUSE

Food and Drug Administration (FDA) approval of its proprietary sildenafil cream formulation in the future, Daré Bioscience is making DARE to PLAY™ available as a Section 503B compounded product, manufactured in an outsourcing facility subject to FDA inspection and under current Good Manufacturing Practice (cGMP) regulations to ensure quality, strength and consistency. Compounded drug products are not FDA approved. The first-of-its-kind cream called "Dare to Play" contains sildenafil, the same active ingredient in Viagra. The topical treatment works by increasing blood flow in the vagina, improving sensation and arousal. “We have this scientific evidence that sildenafil as an active ingredient can work if only it were designed and formulated specifically with women in mind and that's really where we came into the equation," Sabrina Martucci Johnson, president and CEO of Dare Bioscience was quoted as saying by New York Post. But for women, comparable progress on enhancing the natural arousal sensations has stalled for nearly three decades." The Southern California company stated that it was continuing to seek necessary approvals for the product from the US Food and Drug Administration (FDA), adding that its effectiveness was backed by toxicology studies, multiple clinical trials and peer-reviewed research. During the trials, the Dare to Play cream increased libido as well as orgasms with no potential side effects compared to a placebo cream. It was also tested in oral sex situations. "Phase 2b trial included 200 premenopausal women experiencing symptoms of female sexual interest/arousal disorder, such as reduced genital sensation and frustration during intimacy," the company said. After 12 weeks, women who used the cream reported an increase in arousal as well as key areas of sexual function, including desire and orgasm. Johnson said the new cream represents a "long overdue correction" that allows women an option to reconnect with their own bodies, with science finally recognising their needs as well. As for why a pill akin to those used by men was not developed, Johnson said a female pill viagra tablet for sex would require a lot of sildenafil. She added that the option was "just not practical" as it would require much higher doses than what men generally need. Residents of Connecticut, Florida, Indiana, Missouri, New Hampshire, New Jersey, Oregon, Pennsylvania, Rhode Island and Utah can pre-order the cream already. Track Latest News Live on NDTV.com and get news updates from India and around the world Developed and evaluated specifically for women, DARE to PLAY™ Sildenafil Cream is a first-of-its-kind female arousal cream, a non-hormonal topical cream shown in clinical studies to increase genital blood flow in 10–15 minutes, and improve arousal sensations based on clinically-validated endpoints. Market introduction of DARE to PLAY™ is expected to mark a breakthrough in women’s sexual health and represents important progress toward closing one of medicine’s most persistent gender gaps. SAN DIEGO, Dec. 10, 2025 (GLOBE NEWSWIRE) -- Daré Bioscience, Inc.

Year	Estimated Sales (Units)	Growth Rate (%)	Key Markets
2022	500,000	12%	US, Europe, Asia
2023	560,000	12%	US, Europe, Asia
2024	630,000	12.5%	US, Europe, Middle East

(NASDAQ: DARE), a purpose-driven health biotech company solely focused on closing the gap in women’s health between promising science and real-world solutions, today announced that providers in select states can now begin prescribing DARE to PLAY™ Sildenafil Cream, a proprietary topical arousal cream designed specifically for women to enhance genital blood flow and arousal response. DARE to PLAY™ represents the first and only evidence-backed sildenafil cream formulation for women. Its commercial availability through a 503B outsourcing facility will mark the first time a topical sildenafil formulation manufactured in accordance with cGMP requirements and supported by clinical data will be accessible to women. DARE to PLAY™ uses sildenafil, the same active ingredient found in Viagra®, to improve genital blood flow.

LinkOut - more resources

Read more about the Phase 2b clinical study here. Regulatory Strategy for Sildenafil Cream, 3.6%: Next Steps The Company is working to align with the FDA on the Phase 3 study design. At the conclusion of the development program, if successful, Daré intends to leverage the existing safety and efficacy data for sildenafil to utilize the FDA’s 505(b)(2) pathway to obtain marketing approval of Sildenafil Cream, 3.6% for the treatment of women in the U.S. DOI: 10.1016/j.sxmr.2016.03.002 Ad Hoc Market Research: FSAD Prevalence Report (Oct 2015) conducted for SST LLC. Based on US Census projections for 2016.

Other Literature Sources

Dare Bioscience developed Dare to Play, a cream boosting female sexual arousal in 10 minutes The cream contains sildenafil, the active ingredient in Viagra, increasing vaginal blood flow Clinical trials showed Dare to Play improved libido and orgasms with no side effects versus placebo Over three decades after the invention of Viagra, a little blue pill that allows men to boost their sexual performance, scientists have developed a similar alternative for women. US-based health biotech group Dare Bioscience has created a $10 a use product that works in just 10 minutes and boosts women's arousal. The first-of-its-kind cream called "Dare to Play" contains sildenafil, the same active ingredient in Viagra. The topical treatment works by increasing blood flow in the vagina, improving sensation and arousal. “We have this scientific evidence that sildenafil as an active ingredient can work if only it were designed and formulated specifically with women in mind and that's really where we came into the equation," Sabrina Martucci Johnson, president and CEO of Dare Bioscience was quoted as saying by New York Post.

How to Prevent Vaginal Dryness During Menopause

But for women, comparable progress on enhancing the natural arousal sensations has stalled for nearly three decades." The Southern California company stated that it was continuing to seek necessary approvals for the product from the US Food and Drug Administration (FDA), adding that its effectiveness was backed by toxicology studies, multiple clinical trials and peer-reviewed research. During the trials, the Dare to Play cream increased libido as well as orgasms with no potential side effects compared to a placebo cream. It was also tested in oral sex situations. "Phase 2b trial included 200 premenopausal women experiencing symptoms of female sexual interest/arousal disorder, such as reduced genital sensation and frustration during intimacy," the company said. After 12 weeks, women who used the cream reported an increase in arousal as well as key areas of sexual function, including desire and orgasm. Applied topically, it’s designed for use as needed, to enhance the body’s natural arousal response without systemic effects, providing women with a new, evidence-based tool to take charge of their sexual health.

• Viagra cream can provide localized effects on erectile tissue.
• It might offer quicker results than oral medications.
• Some products claim longer-lasting erections with topical use.
• Topical application reduces the risk of some systemic adverse effects.
• Efficacy reports are anecdotal; clinical trials are limited.
• Proper application involves a gentle massage into the skin.
• Dosage instructions are essential for safety and effectiveness.
• Not recommended for use by women or children.
• Some products may contain unverified or unsafe ingredients.
• Always verify the legitimacy of the product before purchase.

“When Viagra 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 three decades,” said Sabrina Martucci Johnson, President and CEO of Daré Bioscience. “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.” Existing products promoted for arousal lean heavily on marketing language, consumer reviews, and lifestyle branding without real evidence. DARE to PLAY™ is the first and only topical formulation of sildenafil developed specifically for women and backed by: Toxicology studies covering oral, anal, vaginal, and reproductive health; Multiple clinical trials in women, including a randomized placebo-controlled study with 200 women and their sexual partners; and Published, peer-reviewed research in medical journals such as The Green Journal, the official publication of the American College of Obstetrics and Gynecology (ACOG) and the Journal of Sexual Medicine, the official publication of the International Society for the Study of Women’s Sexual Health (ISSWSH). “As more women speak openly about their sexual health, the need for research-backed solutions has never been greater,” said Dr. Irwin Goldstein, Director of San Diego Sexual Medicine and a founder of ISSWSH. “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.” While continuing activities necessary to seek U.S. Food and Drug Administration (FDA) approval of its proprietary sildenafil cream formulation in the future, Daré Bioscience is making DARE to PLAY™ available as a Section 503B compounded product, manufactured in an outsourcing facility subject to FDA inspection and under current Good Manufacturing Practice (cGMP) regulations to ensure quality, strength and consistency. Compounded drug products are not FDA approved.