Safety and Efficacy of Sildenafil Citrate for the Treatment of Female Sexual Arousal Disorder: A Double-Blind, Placebo Controlled Study
Giuliano F, Hultling C, El Masry WS, Smith MD, Osterloh IH, Orr M et al. Randomized trial of sildenafil for the treatment of erectile dysfunction in spinal cord injury.
| Study Name | Focus Area | Results Summary | Year | Notes |
|---|---|---|---|---|
| Women's Sildenafil Study I | Arousal and blood flow | Improved arousal scores | 2021 | Small sample size |
| Female ED Treatment Trials | Efficacy and safety | Favorable results, some side effects | 2022 | Larger scale studies ongoing |
| Off-label Sildenafil Use in Women | Safety profile | Generally safe, monitor side effects | 2023 | Regulatory approval pending |
| Clitoral Blood Flow Enhancement Study | Blood flow and sensitivity | Significant improvements | 2024 | Supporting further research |
Maytom MC, Derry FA, Dinsmore WW, Glass CA, Smith MD, Orr M et al.
- 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.
A two-part pilot study of sildenafil (VIAGRA) in men with erectile dysfunction caused by spinal cord injury. Hultling C, Giuliano F, Quirk F, Peña B, Mishra A, Smith MD .
DARE to PLAY Sildenafil Cream
Sexual arousal and orgasm in women: effects of spinal cord injury. The effects of spinal cord injury on psychogenic sexual arousal in males. Sexual responsiveness in women with spinal cord injuries: differential effects of anxiety-eliciting stimulation. Arch Sex Behav 2004; 33: 295–302. Effects of level and degree of spinal cord injury on male orgasm. Quality of life in patients with spinal cord injury receiving Viagra (sildenafil citrate) for the treatment of erectile dysfunction.
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Sildenafil effects on sexual and cardiovascular responses in women with spinal cord injury. Diagnostic and Statistical Manual of Mental Disorders DSM-IV-TR 4th edn (Text Revision). Development of a sexual function questionnaire for clinical trials of female sexual dysfunction.
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The study was conducted at clinical practice sites in North America (n =23), 11 European countries (n =23), Australia (n =4) and South Africa (n =2). 129 women were randomized and treated sildenafil citrate sublingual tablets 100mg with sildenafil or matching placebo. A 4-week baseline period was followed by 12 weeks of treatment, which could be increased from 50 to 100 mg or decreased to 25 mg once during the treatment period, depending on efficacy and tolerability. By use of an event log, sexual activity was monitored between screening and the end of treatment. The Sexual Function Questionnaire, the Sexual Quality of Life Questionnaire–Female, a global efficacy question and Sexual Distress Question were also assessed.
Study design:
Sildenafil-treated women and placebo-treated women had an increase in their percentage of sexual activities throughout the course of the study, with no statistically significant difference between groups in the percentage of successful sexual activities at end of treatment versus baseline. There were also no statistically significant differences between sildenafil- and placebo-treated women on the aforementioned measures. The most common adverse events included headache and vasodilatation. The results of this study are similar to other reports regarding a lack of clinically meaningful benefit of sildenafil in other populations of women. This study was sponsored by Pfizer Inc. J Womens Health Gend Based Med 2002; 11: 277–289. The use of the sexual function questionnaire as a screening tool for women with sexual dysfunction.
- Sildenafil is often known by the brand name Viagra, primarily for men.
- Researchers are exploring other PDE5 inhibitors for women’s sexual health.
- Efficacy of sildenafil in women might depend on underlying health conditions.
- Women with cardiovascular issues should be particularly cautious with sildenafil.
- Some women report increased sexual satisfaction after using sildenafil.
- Medical advice is crucial before women consider sildenafil as a treatment.
Development of a questionnaire on sexual quality of life in women. Phosphodiesterase type 5 inhibitors and female sexual response: faulty protocols or paradigms? This study was sponsored by Pfizer Inc.
| Brand Name | Formulation | Dosage Options | Notes |
|---|---|---|---|
| Viagra Women | Oral tablet | 25 mg, 50 mg | Off-label use, not approved by FDA |
| Female Arousal Gel | Topical gel | N/A | Claimed to enhance blood flow |
| Sildenafil Citrate | Generic oral tablet | 25-100 mg | Widely used off-label in women |
| Custom Compounded | Customized formulations | Variable | Prescribed by special clinics |
Editorial support was provided by Anne Johnson, Janet E Matsuura, PhD, and Deborah M Campoli-Richards, BSPharm, RPh, of Complete Healthcare Communications, Inc., and was funded by Pfizer Inc.
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Keep all medication out of sight and reach of children as many containers are not child-resistant. Place the medication in a safe location – one that is up and away and out of their sight and reach. Dispose of unneeded medications in a way so that pets, children, and other people cannot take them. Do not flush this medication down the toilet. Talk to your pharmacist about take-back programs in your community.
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Visit the FDA's Safe Disposal of Medicines website for more information. In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911. Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription. Marca Sipski Alexander reports no commercial interests with the study sponsor. Raymond Rosen reports no current commercial interests with the study sponsor. At the time of this research, Dr Rosen served as a consultant and research advisor for Pfizer Inc.
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The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. does not endorse or recommend the use of any drug. The information is not a substitute for medical care. To evaluate the efficacy, safety and tolerability of oral sildenafil in women with female sexual arousal disorder as a result of SCI (paraplegia/tetraplegia). Claes Hultling reports no commercial interests with the study sponsor.
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Gain free access to this article, as well as selected content from this journal and more on nature.com Targeting recovery: priorities of the spinal cord-injured population. Targeting recovery: priorities of the spinal cord-injured population. Sexual activities, response and satisfaction in women pre- and post-spinal cord injury. Sexual activities, desire, and satisfaction in males pre- and post-spinal cord injury. Arch Sex Behav 1993; 22: 217–228. Tara Symonds and Scott Haughie are employees of Pfizer. Susanne Steinberg was an employee of Pfizer when the study was conducted. Sildenafil in women with sexual arousal disorder following spinal cord injury. Sexual Health in the Neurogenic Patient Current Bladder Dysfunction Reports (2020) Knowledge Gaps in Urologic Care of Female Spinal Cord Injury Patients Current Urology Reports (2019) Sexual Function after Spinal Cord Injury: Innervation, Assessment, and Treatment Current Sexual Health Reports (2016) Learn more about compounded Sildenafil creams made for women.
Mechanism of action
Do not take a double dose to make up for a missed one. Tell your doctor if any of these symptoms are severe or do not go away: numbness, burning, or tingling in the arms, hands, feet, or legs pain in muscles, back, arms, or legs changes in color vision (seeing a blue tinge on objects or having difficulty telling the difference between blue and green) If you experience any of the following symptoms, call your doctor immediately: sudden severe loss of vision (see below for more information) erection that is painful or lasts longer than 4 hours rash; itching; hives; difficulty breathing or swallowing; swelling of the eyes, face, throat, tongue, or lips Some patients experienced a sudden loss of some or all of their vision after they took sildenafil or other medications that are similar to sildenafil. The vision loss was permanent in some cases. It is not known if the vision loss was caused by the medication. If you experience a sudden loss of vision while you are taking sildenafil, call your doctor immediately.
Bupropion (Wellbutrin)
Do not take any more doses of sildenafil or similar medications such as tadalafil (Cialis) or vardenafil (Levitra) until you talk to your doctor. There have been reports of heart attack, stroke, irregular heartbeat, bleeding in the brain or lungs, high blood pressure, and sudden death in men who took sildenafil for erectile dysfunction. Most, but not all, of these people had heart problems before taking sildenafil. It is not known whether these events were caused by sildenafil, sexual activity, heart disease, or a combination of these and other causes.Talk to your doctor about the risks of taking sildenafil. Some patients experienced a sudden decrease or loss of hearing after they took sildenafil or other medications that are similar to sildenafil.
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It is not known if the hearing loss was caused by the medication. If you experience a sudden loss of hearing, sometimes with ringing in the ears or dizziness, while you are taking sildenafil, call your doctor immediately. If you are taking sildenafil (Viagra) for erectile dysfunction, do not take any more doses of sildenafil (Viagra) or similar medications such as tadalafil (Cialis) or vardenafil (Levitra) until you talk to your doctor. If you are taking sildenafil (Liqrev, Revatio) for PAH, do not stop taking your medication until you talk to your doctor. Call your doctor if you have any unusual problems while you are taking this medication.
