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

Though many men don’t like to talk about it, ejaculation problems are very common. Some of the most common issues include premature, delayed, or retrograde ejaculation.

• Viagra cream is considered experimental by many health authorities.
• It is not approved by the FDA for medical use.
• Efficacy evidence mainly comes from anecdotal reports.
• Risks associated include allergic reactions and skin burns.
• It can be part of a broader treatment plan for ED.
• Safe disposal of unused cream is necessary to prevent misuse.
• The cream may interact with other medications, demanding caution.
• Clinical trials are needed to confirm safety and efficiency.
• Patients should report adverse effects promptly.
• Distribution channels are often unregulated, so caution is advised.

Your pelvic floor is a lot like plumbing in your home: you never really think about it unless something goes wrong.

Where the Magic Happens

Though many men don’t like to talk about it, ejaculation problems are very common. Some of the most common issues include premature, delayed, or retrograde ejaculation. Your pelvic floor is a lot like plumbing in your home: you never really think about it unless something goes wrong. When you think of male sexual dysfunction, concerns like erectile dysfunction (ED) or premature ejaculation (PE) probably come to mind first. But there’s another sex-related issue that’s more common in men than you might expect: difficulty orgasming.

Can topical sildenafil improve sex?

Female sexual arousal disorder (FSAD) FSAD, as described in the Diagnostic and Statistical Manual 4th Edition (DSM-IV), is a condition characterized as a persistent or recurrent inability to attain or maintain sufficient genital arousal (an adequate lubrication-swelling response) during sexual activity, frequently resulting in distress or interpersonal difficulty. Of the various types of female sexual dysfunction disorders, FSAD is most analogous to erectile dysfunction (ED) in men. There are currently no FDA-approved therapies for FSAD. 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. When you think of male sexual dysfunction, concerns like erectile dysfunction (ED) or premature ejaculation (PE) probably come to mind first. But there’s another sex-related issue that’s more common in men than you might expect: difficulty orgasming. Female sexual arousal disorder (FSAD) FSAD, as described in the Diagnostic and Statistical Manual 4th Edition (DSM-IV), is a condition characterized as a persistent or recurrent inability to attain or maintain sufficient genital arousal (an adequate lubrication-swelling response) during sexual activity, frequently resulting in distress or interpersonal difficulty.

Of the various types of female sexual dysfunction disorders, FSAD is most analogous to erectile dysfunction (ED) in men. There are currently no FDA-approved therapies for FSAD. 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. 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.

Get on the List

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.

Real results from real women

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. 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. 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 viagra over the counter 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 viagra alternative uk 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. 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. 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.

How does it work?

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.

CUSTOM FORMULATED

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. But for women, comparable progress on enhancing viagra vardenafil 20mg 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. Based on US Census projections for 2016.

OUR PRE-FULFILLMENT PRESCRIPTION PERIOD HAS BEGUN.

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. 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.

Though you cannot place an order quite yet...

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 viagra over the counter 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. 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 concept of Viagra cream emerged as a topical alternative.
• It is intended to bypass gastrointestinal absorption issues.
• Topical use may reduce the risk of cardiovascular side effects.
• Some formulations include additional botanicals for enhancement.
• It is part of a growing market for personal sexual wellness products.
• Regulations vary by country; some products are unapproved.
• Expect a warming or tingling sensation upon application.
• The cream should be stored in a cool, dry place.
• Discontinue use if skin redness or irritation occurs.
• Use as directed to prevent overdose or adverse reactions.

The first-of-its-kind cream called "Dare to Play" contains sildenafil, the same active ingredient in Viagra.

The Alloy Promise

All participants had a main diagnosis of FSAD and may have also had concomitant viagra alternative uk 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. 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).

Cell Signal

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. Read more about the Phase 2b clinical study here. 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 viagra vardenafil 20mg 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 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.