Female sexual arousal disorder is clinically analogous to male erectile dysfunction, characterized by impaired blood flow to genital tissues.
Are there other uses for this medicine?
Dr. Brainard's practice received funding from Daré Bioscience for study specific activities. Dr. Goldstein also reported receiving payments from Nuvig, Ipsen, and AbbVie. This is a phase 2b study of topical sildenafil cream 3.6%, which is being developed clinically for the treatment of female sexual arousal disorder.
Erectile dysfunction
The study was conducted under a U.S. Food and Drug Administration–approved investigational new sildenafil 10mg drug application. Each author has confirmed compliance with the journal's requirements for authorship. This is an open access article distributed under the terms of the Creative Commons Attribution-Non Commercial-No Derivatives License 4.0 (CCBY-NC-ND), where it is permissible to download and share the work provided it is properly cited. The work cannot be changed in any way or used commercially without permission from the journal. Oral sildenafil citrate (Viagra) was approved in 1998 for the treatment of erectile dysfunction.
- Clinical research into sildenafil for women includes various dosage trials.
- Women using sildenafil should monitor blood pressure to avoid adverse effects.
- The safety profile of sildenafil in women is less documented than in men.
- Sildenafil’s impact on female sexual desire is still under scientific investigation.
- Women should avoid sildenafil if pregnant or breastfeeding unless prescribed.
- Alternative therapies for female sexual dysfunction include counseling and hormone therapy.
Published placebo-controlled trials of oral sildenafil administered in premenopausal and postmenopausal women afflicted with broad-spectrum female sexual dysfunction (eg, hypoactive sexual desire disorder, female sexual arousal disorder, female orgasmic disorder, dyspareunia) demonstrated marginal efficacy compared with placebo6–9 with high incidences of intolerable side effects.
| Product | Dosage | Quantity + Bonus | Price | |
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| Kamagra Oral Jelly | 100mg | 220 + 18 Sachets | 662.24€ 630.70€ | |
| Viagra Generic | 100mg | 20 Pills | 45.58€ 43.41€ | |
| Kamagra Oral Jelly | 100mg | 21 Sachets | 95.92€ 91.35€ | |
| Kamagra Soft Tabs | 100mg | 84 + 4 Pills | 233.05€ 221.95€ | |
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| Kamagra Polo | 100mg | 32 Pills | 125.88€ 119.89€ | |
| Viagra Generic | 150mg | 360 + 10 Pills | 423.48€ 403.31€ | |
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| Viagra Generic | 100mg | 270 + 10 Pills | 270.47€ 257.59€ | |
| Kamagra Polo | 100mg | 84 + 4 Pills | 244.49€ 232.85€ | |
| Viagra Generic | 200mg | 90 + 6 Pills | 170.79€ 162.66€ | |
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| Viagra Generic | 50mg | 120 + 6 Pills | 129.64€ 123.47€ |
Topical sildenafil cream 3.6% (sildenafil cream) has been developed for the treatment of female sexual arousal disorder.
How Does Viagra Affect Women?
In particular, in an exploratory analysis of a subset of women with female sexual arousal disorder with or without concomitant decreased desire, topical sildenafil cream increased sexual arousal sensation, desire, and orgasm and reduced sexual distress. Topical sildenafil cream 3.6% improved outcomes among women with female sexual arousal disorder, particularly an exploratory subset of women with female sexual arousal disorder with or without concomitant decreased desire. Female sexual arousal disorder is a persistent or recurrent inability to attain, or to maintain until completion of the sexual activity, an adequate lubrication-swelling response of sexual excitement that causes marked distress or interpersonal difficulty.1,2 Despite the high prevalence of female sexual arousal disorder (about 20% of U.S. women3–5), to date there are no U.S. Food and Drug Administration (FDA)–approved pharmacologic treatments for female sexual arousal disorder. We hypothesized that by delivering sildenafil citrate topically with a fast-absorbing delivery technology specifically targeting genital anatomy central to the vascular arousal response,10 there would be less systemic exposure, fewer systemic side effects, and a more immediate biological efficacy response.
- Awareness of sildenafil's potential side effects helps women make informed choices.
- Women should avoid using sildenafil with nitrates to prevent dangerous drops in blood pressure.
- Proper diagnosis of sexual dysfunction can guide appropriate treatment options.
- Scientific research continues to explore safer, women-specific sexual health drugs.
- Sildenafil’s long-term effects on women are not yet fully understood.
- Healthcare providers can help determine if sildenafil is appropriate for individual cases.
Before the start of the study, we conducted a qualitative content validity study among women with female sexual arousal sildenafil 130mg disorder to ensure that the efficacy endpoints, which were patient-reported outcome measures, were fit for purpose and valid for this specific population.11 This clinical trial was conducted at 49 sites in the United States, approved by the Advarra IRB (Pro00049161), and registered at ClinicalTrials.gov (NCT04948151).
- 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.
Healthy premenopausal women aged 18 years or older and their sexual partners were screened for the study.
| Age Group | Considerations | Recommended Dosage | Notes |
|---|---|---|---|
| 20-30 years | Generally healthy | 25 mg | Consult doctor if contraindicated |
| 31-50 years | Possible hormonal changes | 25-50 mg | Monitor for side effects |
| 51+ years | Increased health risks | 25 mg | Under medical advice |
| Postmenopausal | Effectiveness varies | Variable | Focus on overall health |
Volunteers and their sexual partners provided written informed consent before the performance of any study-related procedures. Women at risk of pregnancy used effective contraception during the study (eg, hormonal contraception).
How should this medicine be used?
It's also worth remembering that the effects of Viagra in women are not as well understood as in men, and they may vary from person to person. Since Viagra isn't specifically approved for use in women, these timeframes are based on limited research and anecdotal evidence. Thought you might appreciate this item(s) I saw in Obstetrics & Gynecology. Your message has been successfully sent to your colleague. Some error has occurred while processing your request.
Setting and Sample
Preliminary Efficacy of Topical Sildenafil Cream for the Treatment of Female Sexual Arousal Disorder Johnson, Isabella MS; Thurman, Andrea Ries MD; Cornell, Katherine A. BS; Hatheway, Jessica MBA; Dart, Clint MS; Brainard, C. Paige MD; Friend, David R. PhD; Goldstein, Andrew MD Daré Bioscience, San Diego, California; Strategic Science & Technologies, LLC, Cambridge, Massachusetts; Premier Research, Morrisville, North Carolina; and Copperstate OB/GYN, Tucson, Arizona. Corresponding author: Andrea Ries Thurman, MD, Daré Bioscience, San Diego, CA; [email protected]. Male condoms could be used for sexually transmitted infection prevention.
| Trend | Description | Potential Impact |
|---|---|---|
| Development of women-specific formulations | Customized doses and delivery methods | Improved safety and efficacy |
| Combination therapies | Sildenafil combined with other agents | Potentially enhanced outcomes |
| Non-oral delivery systems | Topicals, patches, or injectables | Increased convenience and quicker onset |
| Personalized medicine approaches | Genetic testing to optimize treatment | Higher success rates with fewer side effects |
| Increased clinical trials in women | More robust evidence for approval | Better guideline development |
The coprimary efficacy endpoints were the change from baseline to week 12 in the Arousal Sensation domain of the SFQ38 (Sexual Function Questionnaire) and question 14 of the FSDS-DAO (Female Sexual Distress Scale—Desire, Arousal, Orgasm).
Key Words
To assess the efficacy of topical sildenafil cream, 3.6% among healthy premenopausal women with female sexual arousal disorder. We conducted a phase 2b, exploratory, randomized, placebo-controlled, double-blind study of sildenafil cream. Coprimary efficacy endpoints were the change from baseline to week 12 in the Arousal Sensation domain of the SFQ28 (Sexual Function Questionnaire) and question 14 of the FSDS-DAO (Female Sexual Distress Scale—Desire, Arousal, Orgasm). Two hundred women with female sexual arousal disorder were randomized to sildenafil cream (n=101) or placebo cream (n=99). A total of 174 participants completed the study (sildenafil 90, placebo 84).
Interactions with other medications
Among the intention-to-treat (ITT) population, which included women with only female sexual arousal disorder and those with female sexual arousal disorder with concomitant sexual dysfunction diagnoses or genital pain, although the sildenafil cream group demonstrated greater improvement in the SFQ28 Arousal Sensation domain scores, there were no statistically significant differences between sildenafil and placebo cream users in the coprimary and secondary efficacy endpoints. An exploratory post hoc subset of the ITT population with an enrollment diagnosis of female sexual arousal disorder with or without concomitant decreased desire randomized to sildenafil cream reported significant increases in their SFQ28 Arousal Sensation domain score (least squares mean 2.03 [SE 0.62]) compared with placebo cream (least squares mean 0.08 [SE 0.71], P=.04). This subset achieved a larger mean improvement in the SFQ28 Desire and Orgasm domain scores. This subset population also had significantly reduced sexual distress and interpersonal difficulties with sildenafil cream use as measured by FSDS-DAO questions 3, 5, and 10 (all P≤.04). Topical sildenafil cream improved outcomes among women with female sexual arousal disorder, most significantly in those who did not have concomitant orgasmic dysfunction. A one-on-one clinical interview was conducted with each potential participant, using interviewers who were not employees of the study sponsor and who were recognized experts in the field, to establish the diagnosis of female sexual arousal disorder and to verify that female sexual arousal disorder was the woman's main sexual dysfunction concern if other concomitant sexual dysfunction diagnoses or symptoms existed.
- The legality of women using sildenafil varies by country and local regulations.
- Lifestyle modifications can complement medication for better sexual health outcomes.
- Women with diabetes may have different responses to sildenafil therapy.
- The stigma surrounding female sexual dysfunction can hinder treatment seeking.
- Advances in research are aimed at developing female-specific ED medications.
- Open discussions with physicians are essential for safe and effective treatments.
The clinical interview documented those concomitant diagnoses or symptoms for exploratory post hoc analyses based on sexual dysfunction diagnoses or symptoms at enrollment. The first screening occurred in July 2021, and the last participant visit was in April 2023.
| Tip | Explanation | Rationale |
|---|---|---|
| Take on an empty stomach | Food, especially high-fat meals, delays absorption | Ensures faster effect |
| Follow prescribed dosage | Avoid overdose and side effects | Ensures safety and effectiveness |
| Do not mix with nitrates | Risk of severe hypotension | Critical safety warning |
| Monitor for side effects | Report persistent issues to healthcare provider | Ensures prompt management |
| Use with sexual stimulation | Enhances the effectiveness | Maximizes potential benefits |
Appendix 1, available online at outlines the schedule of efficacy evaluations.
DARE to PLAY Sildenafil Cream
For instance, medications such as flibanserin (Addyi) and bremelanotide (Vyleesi) have been approved by the FDA to address hypoactive sexual desire disorder (HSDD) in premenopausal women. These medications work differently than Viagra and are tailored to help with low sexual desire in women. In addition to medical treatments, non-medical approaches like sex therapy, lifestyle changes, and addressing relationship issues can also play a vital role in improving sexual health and satisfaction. In women, Viagra doesn't directly cause vaginal lubrication — ie, "getting wet." Some studies have explored Viagra's effects on women, particularly those with sexual arousal disorders, but the results have been mixed and inconclusive. In women, Viagra can increase blood flow to the genital area, which might enhance physical sensations during arousal and potentially contribute to increased lubrication.
Key takeaways
However, this effect is not direct or guaranteed, and Viagra doesn't act as a lubricant itself. Instead, any impact on lubrication would be indirect and depend on whether the woman experiences increased sexual arousal. If you're experiencing vaginal dryness or issues with lubrication, you're better off using lube! It usually takes about 30 minutes to an hour for Viagra to start working after it's taken orally, and the peak effects typically occur within one to two hours. However, this can vary depending on factors such as metabolism, whether you’re on an empty stomach, and your overall health. In brief, volunteers underwent informed consent and screening safety procedures at visit 1.
What should I do if I forget to take a dose?
This study was funded by Daré Bioscience. Financial Disclosure Clint Dart reports money was paid to his institution from Daré Bioscience. Isabella Johnson, Andrea Ries Thurman, Jessica canadian sildenafil citrate Hatheway, David R. Friend, and Andrew Goldstein are employees of Daré Bioscience. Katherine A.
What should I know about storage and disposal of sildenafil?
Cornell is an employee of Strategic Science & Technologies, LLC. She indicated that this article discusses off-label use, in that sildenafil cream for FSAD is investigated. Clint Dart provided independent data verification and is an employee of Premier Research. C. Paige Brainard was the principal investigator of this study and was financially compensated by Del Sol Research Management for that service.