DARE to PLAY™ represents the first and

Viagra cream's popularity is growing among alternative therapies.
It is often advertised online without regulatory approval.
Users should research product ingredients before use.
Topical application may reduce some systemic side effects.
Temporary side effects include flushing and headache.
Proper technique in application influences effectiveness.
Avoid applying to mucous membranes or broken skin.
Expect some changes in sensation in the applied area.
Do not share or reuse leftover cream.
Discuss potential interactions with healthcare providers.

only evidence-backed sildenafil cream formulation for women.

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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.

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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. US-based health biotech group Dare buy viagra connect online 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. Its commercial availability through a 503B outsourcing facility

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will mark the first time a topical sildenafil

OUR PRE-FULFILLMENT PRESCRIPTION PERIOD HAS BEGUN.

“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.

J Cosmet Las Ther

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 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. formulation manufactured in accordance with cGMP requirements and

Parameter	Details	Optimal Conditions	Notes
Shelf life	24 months	Store in cool, dry place	Avoid high temperatures
Temperature range	15°C to 25°C	Keep away from direct sunlight	Refrigeration not required
Storage location	Original container, upright	Keep out of reach of children	Avoid freezing

supported by clinical data will be accessible to women. DARE to PLAY™ uses sildenafil, the same active

Viagra cream offers potential for personalized dosing.
It might be used in combinations with other topical therapies.
Some formulations include numbing agents for comfort.
The market is driven by demand for non-invasive ED solutions.
Long-term safety data is currently lacking.
Its use is often driven by convenience and privacy.
The cream's active ingredient is usually sildenafil, similar to tablets.
Some products claim to enhance libido beyond ED treatment.
Use of Viagra cream does not replace professional diagnosis.
Monitoring by healthcare providers is advised when used regularly.

ingredient found in Viagra®, to improve genital blood flow.

Psychological Dimensions: Arousal and Embodiment

A meta-analysis of 95 studies from 2000-2014 indicated prevalence of Female Sexual Dysfunction in premenopausal women worldwide is 41%, and difficulty with arousal alone is 23%.1 Market research estimates: 33% of US women aged 21 to 60 (~ 20 million women), experience symptoms of low or no sexual arousal.2,310 million women in the US are considered distressed and actively seeking treatment.2 33% of US women aged 21 to 60 (~ 20 million women), experience symptoms of low or no sexual arousal.2,3 10 million women in the US are considered distressed and actively seeking treatment.2 To put the market opportunity for an FDA-approved FSAD treatment in context, a PDE5 inhibitor utilized in an ED medication for men – Viagra® — peaked at $2.05 billion in sales in 2012.4 Orally administered sildenafil, a phosphodiesterase-5 (PDE-5) inhibitor, received FDA approval in 1998 for the treatment of erectile dysfunction in men and is marketed under the brand name Viagra®. Given the underlying pathophysiologic similarities of ED and FSAD, using sildenafil to direct blood to the genitals before sexual activity could provide a potential improvement in genital arousal response and overall sexual experience for women as it does in men. Sildenafil Cream, 3.6% is an investigational proprietary topical formulation of sildenafil being developed as a first-in-category option for women for the treatment of FSAD. Unlike the oral formulations of PDE-5 inhibitors, Sildenafil Cream is applied locally to the vaginal tissue and is designed to facilitate vasodilation and increased blood flow directly to the genital tissue to improve the physical arousal response symptoms commonly associated with FSAD while avoiding systemic side effects observed with oral formulations of sildenafil. Phase 1 and Phase 2a Clinical Studies, Previously Completed In a Phase 1 clinical study in 20 healthy post-menopausal women, topical sildenafil cream was safe and well tolerated at clinically relevant doses, and study subjects reported favorable product characteristics: easy to use and readily absorbed.

Effect of weight loss on cellulite: gynoid lypodystrophy

In a Phase 2a study in women with FSAD (15 pre-menopausal and 16 post-menopausal), Sildenafil Cream increased measurable blood flow to the genital tissue compared to placebo cream. 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%. Applied topically, it’s designed for use as needed,

The development of Viagra cream aims to improve convenience.
It may allow for quicker libido response times.
Compatibility with condom use varies; check labels.
Some formulations are designed for extended release.
Users with sensitive skin should opt for hypoallergenic versions.
The safety profile of long-term topical use is not well-established.
Dosage may be adjusted based on individual needs.
Always follow storage and usage instructions carefully.
Using too much can lead to unwanted side effects.
Disclosure with a healthcare professional is recommended.

to enhance the body’s natural arousal response without

Hear how patients are reclaiming their lives with Winona:

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.

How it Helps You Do It

placebo used in patients’ home setting. 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. systemic effects, providing women with a new, evidence-based

Up to 40% of women report low sexual desire or interest, and women are 2-3x more likely than men to experience a decline in sex drive as they age

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. (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. tool to take charge of their sexual health.

Country	Regulatory Body	Status	Notes
United States	FDA	Approved for research only	Not for medicinal use
EU	EMA	Under review	Pending approval
Canada	Health Canada	Approved	Sale restrictions
Australia	TGA	Not approved	Banned for sale