Sildenafil improves sexual functioning in premenopausal women with type 1 diabetes who are affected by sexual arousal disorder: a double-blind, crossover, placebo-controlled pilot study

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). 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.

• 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.

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).

Related questions

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. 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.

Read more like this

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. 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. 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.

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.

Non-medical use

While Viagra may help with certain aspects of sexual arousal, it doesn’t address the root cause of sexual dysfunction in women. 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. If you're facing sexual difficulties, know that there are treatments designed specifically for women. 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.

Bupropion (Wellbutrin)

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. 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. women3–5), to date there are no U.S.

Medical uses

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. To assess the efficacy of sildenafil otc 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. Food and Drug Administration (FDA)–approved pharmacologic treatments for female sexual arousal disorder. Female sexual arousal disorder is clinically analogous to male erectile dysfunction, characterized by impaired blood flow to genital tissues.

• 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.

Oral sildenafil citrate (Viagra) was approved in 1998 for the treatment of erectile dysfunction.

Chemical synthesis

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. Dr. Brainard's practice received funding from Daré Bioscience for study specific activities.

Addyi (filbanserin)

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. The study was conducted under a U.S. Food and Drug Administration–approved investigational new drug application. 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. Topical sildenafil cream 3.6% (sildenafil cream) has been developed for the treatment of 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.

Methods and Objectives

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]. This study was funded by Daré Bioscience. Financial Disclosure Clint Dart reports money was paid to his institution from Daré Bioscience.

Raynaud's phenomenon

Isabella Johnson, Andrea Ries Thurman, Jessica Hatheway, David R. Friend, and Andrew Goldstein are employees of Daré Bioscience. Katherine A. 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. Before the start of the study, we conducted a qualitative content validity study among women with female sexual arousal 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). Healthy premenopausal women aged 18 years or older and their sexual partners were screened for the study. 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).

• Sildenafil is a medication primarily used to treat erectile dysfunction in men.
• Women sildenafil is an off-label use aimed at improving female sexual arousal.
• Clinical trials are ongoing to assess efficacy of sildenafil for women.
• Side effects of sildenafil may include headaches, flushing, and nasal congestion.
• Women may experience increased blood flow and libido with sildenafil.
• Proper dosage and medical consultation are essential before use.

Male condoms could be used for sexually transmitted infection prevention. 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). 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 clinical interview documented those concomitant diagnoses or symptoms for exploratory post hoc analyses based on sexual dysfunction diagnoses or symptoms at enrollment.

• Some studies suggest sildenafil might help women with sexual arousal disorder.
• The drug's vasodilating effects can have cardiovascular implications in women.
• Women should be cautious of counterfeit or unapproved sildenafil products.
• Combining sildenafil with other ED drugs in women is not recommended without medical advice.
• Psychological support remains an important aspect of treating female sexual dysfunction.
• Ongoing clinical trials aim to establish the safety and efficacy of sildenafil for women.