Sildenafil in women with sexual arousal disorder following spinal cord injury

There’s no conclusive evidence to suggest that Viagra is effective for women, and it’s generally prescribed as a last resort to women with sexual dysfunction who haven’t seen improvement with other treatments first. While some women may experience positive effects from Viagra, it’s important to keep a few things in mind.

Area of Research	Focus	Expected Outcomes	Challenges
Larger clinical trials	Efficacy and safety validation	Better approval pathway	Funding, recruitment difficulties
Combination therapies	Sildenafil with hormonal or psychological treatments	Enhanced effects	Interaction management
Delivery methods innovations	Topical, transdermal, or implantable forms	Increased convenience	Development complexity
Long-term safety studies	Effects of prolonged use	Safety confirmation	Ethical and logistical hurdles

It’s been extensively studied by Pfizer (the pharmaceutical company who manufacture Viagra) in a broad range of women without demonstrating efficacy in increasing arousal that is significantly greater than placebo.

Further information

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 50g Sildenafil Cream, 3.6%: Next Steps The Company is working to align with the FDA on the Phase 3 study design.

Anatomy and physiology of female sexual function and dysfunction: classification

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. Viagra is a well-known drug for treating erectile dysfunction in men, but it’s sometimes used off-label in women, too. While Viagra is primarily designed for men, there’s been growing interest in how it might affect women.

Increased genital blood flow

Below, we look at what Viagra does for women, its potential benefits, and the things you should consider if you’re curious about trying it. Sildenafil, sold under the brand name Viagra, helps achieve and maintain an erection by enhancing blood flow to the penis. When a man is sexually aroused, his body releases nitric oxide into the erectile tissue of his penis. This stimulates an enzyme that produces cyclic guanosine monophosphate (cGMP), which causes the smooth muscle cells to relax and the arteries in the penis to widen. The increased blood flow to the penis causes the erectile tissue to fill with blood, resulting in an erection. The placebo response may be as high as 40% in women in the Viagra clinical trials.

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Viagra isn’t a magic pill for all sexual issues.

How does Viagra work?

Viagra works by maintaining the level of cGMP in the smooth muscle cells, which are only present when a man is sexually aroused. This means that Viagra won’t automatically give a man an erection all on its own, because arousal is still required. Viagra targets sexual performance, rather than desire. Sexual desire (also referred to as libido or sex drive) is influenced by both your mental state and your environment. Everything from your body image and overall mental health, relationship dynamics, to whether your bed is uncomfortable or your partner’s breath stinks all affect desire, AKA how turned on you are.

Sildenafil inhibits phosphodiesterase type 5 in human clitoral corpus cavernousum smooth muscle

Viagra can help on the sexual arousal front (by increasing blood flow to the genitals), but it doesn’t address the sexual desire part. So yes, while Viagra can help someone with a penis get and maintain an erection, popping that little blue pill isn’t enough. So now that you know how Viagra works in men, what does that mean for women? The idea behind using Viagra for women is similar to how it works in men—it’s thought that the increased blood flow could potentially improve sexual arousal by increasing blood flow to the clitoris and vagina. Even though it’s not FDA-approved for women, some doctors prescribe Viagra off-label to treat sexual dysfunction.

Obstet. Gynecol.

Female sexual dysfunction (FSD) is defined as a disorder of sexual desire, arousal, orgasm, and/or sexual pain. It’s a pretty broad term used to describe a complex condition. And like many aspects of female sexual health, it’s poorly researched and pretty hard to diagnose. FSD can affect different aspects of your sex life depending on what kind of sexual dysfunction you're experiencing: Low libido: A lack of sexual interest and desire to be sexual Arousal disorder: Difficulty to become or stay aroused Orgasmic disorder: A persistent and recurrent difficulty in achieving orgasm Depending on what you’re struggling with, Viagra may help. Viagra may increase blood flow to the vulva, which could help buy pills sildenafil with sexual performance issues such as vaginal lubrication, sensation, and pleasure. Women’s sexual health is complex and can be influenced by a range of factors, including physical health, emotional well-being, past trauma, and relationship dynamics.

Side Effect	Severity	Frequency	Management
Headache	Mild to Moderate	Common	Analgesics, hydration
Flushing	Mild	Common	Cooling measures
Dizziness	Mild	Occasional	Sit/lie down, avoid sudden standing
Nasal Congestion	Mild	Common	Decongestants if needed
Vision Changes	Rare	Rare	Stop medication if occurs

If you’re experiencing sexual difficulties, it’s important to consider all potential causes and solutions, not just medication.

• Sildenafil's effect duration in women may range from 4 to 6 hours.
• It may help women experiencing low libido linked to blood flow issues.
• The drug’s efficacy in women is less predictable than in men.
• Female sexual dysfunction has multiple causes beyond blood flow.

Like any medication, Viagra can have side effects.

How Viagra Works

In turn, this could enhance overall sexual arousal and the ability to achieve orgasm. More pleasurable sex could also increase sexual desire in those dealing with low libido. But in clinical studies, Viagra hasn’t proven to be the cure-all it’s touted to be for women — the reasons for this are incompletely understood but may relate to the lower amount of PDE5 in vaginal and clitoral smooth muscle when compared to men. One review suggests that sildenafil only acts on the physical aspects of arousal (such as lubrication and sensation) and does not completely respond to the complexity of FSD. Other research shows promising results in women experiencing diminished arousal as a side effect of taking selective serotonin reuptake inhibitors (SSRIs), a common type of antidepressant. These can include headaches, flushing, indigestion, and in some rare cases, changes in vision or hearing. There is an absolute contraindication to Viagra. Anyone on nitrates (for angina) must not take Viagra or they may experience a catastrophic drop in blood pressure. It’s essential to talk to a healthcare provider before taking Viagra to understand the risks and whether it’s appropriate for you.

• Psychological support can enhance the effectiveness of medical treatments.
• Female sexual health is complex and multifaceted.
• Sildenafil should not replace comprehensive sexual health assessments.
• Evidence supports combining medication with behavioral therapies.

The bottom line is that FSD is a complex, multi-factorial issue that can show up in the bedroom in more ways than one. While Viagra may help with certain aspects of sexual arousal, it doesn’t address the root cause of sexual dysfunction in women.

2. Upsides

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. 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.

Sexual dysfunction in the United States: prevalence and predictors

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). 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.

Understanding Female Sexual Arousal Disorder (FSAD)

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. If you’re curious about how Viagra might work for you, it’s crucial to approach this decision with caution and under the guidance of your healthcare professional.