Sildenafil cream demonstrates safety, efficacy in phase 2b study for female sexual arousal disorder

Indeed these results were opposite to the study of Dasgupta et al.

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These results mean that sexual function of women resident in cities is better than those living in villages. This may be due to better level of education, sexual knowledge or socioeconomic factors. [11] concluded that men and women who had trouble in paying their bills were twice as likely to report sexual dysfunctions compared with peers without such economic troubles. In women, there was also a statistically significant trend of increasing sexual dysfunction prevalence with decreasing income. As regard masturbation practice before marriage, it was more common among participants living in cities.

A Note on Gender and Sex Terminology

In the current study 53.85% of participants living in towns and 46.15% in villages; about 80.76% of them stated that they did not know what masturbation is. This can be attributed to customs and traditions which to some extent discourage sexual education especially among females. [12] found that sexual satisfaction seemed to be associated with residence as (26.4%) and (39.1%) of participants living in town were very and moderately sexually satisfied compared to (18.2%) and (20.5%) of women living in villages who were very and moderately sexually satisfied. Regarding masturbation (17.3%) of town residents practiced it before marriage versus (11.4%) of those living in a village and (59%) of participants living in town and (54.5%) of participants living in rural areas stated that they did not know what masturbation is. This study revealed no significant differences between both groups regarding their baseline sexual desire or orgasm (Table 2). [14] which included 19 women completed the 2 arms of the double-blind phase and 12 completed the optional open label extension phase. Statistically significant improvement following sildenafil was only reported in the lubrication domain of sexual function during the double-blind phase.

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There was no overall change in quality of life after sildenafil. [15] found that efficacy was shown on only one sexual function measure and only in a small subsample of women who had no associated hypoactive sexual desire disorder (HSDD) and had sufficient estradiol and free testosterone concentration or were receiving estrogen and/ or androgen replacement therapy.

• 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.

Proposed reasons for the unconvincing efficacy of sildenafil in women have included failure to adequately characterize the study populations, differences in the physiologic response to sildenafil in men and women, and the mechanism of action of the drug needing to be central and not peripheral. It is also possible that sildenafil from canada lack of concordance between physiological and subjective aspects of women’s sexual experiences need to be further investigated [16]. This study revealed no significant association between both groups in comparison of post treatment regarding sexual dysfunction assessment except in orgasm less than half times, which become (84.6%) versus (30.8%) in sildenafil group and placebo group respectively.

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On the same side, the study carried by Omidi et al. [13] in Iran compared the two groups in terms of primary mean scores of sexual function, sexual satisfaction, and marital satisfaction showed similarities in terms of factors and prevalence of disorders at the beginning of the study. In the treatment arm of the present study, there was improvement in sexual dysfunction particularly in sexual desire, maintenance of lubrication, orgasm and satisfaction. Regarding the desire, the obvious change was in patients with no desire weekly pretreatment to improve from zero to 61.5% post-treatment. The orgasm differences in women who achieved orgasm less than half the time were 38.5% versus 84.6% pre- and post-treatment respectively (Table 2). These results can be supported by the study of Leddy et al. [17]; 13 of 19 (68%) subjects achieved a ≥50% increase in clitoral engorgement from baseline when administered sildenafil or placebo 30 minutes after dose administration. At 60 minutes after administration, 17/19 (89%) subjects receiving sildenafil and 16/19 (84%) subjects receiving placebo had responded (P value 0.3). [16] used self-reported measures of sexual function which showed mixed results whereas studies examining physiological effects of PDE5i on genital vasocongestion consistently report significant effects on genital sexual response.

Author information

All patients in the 2 groups were subjected to: Complete history taking: age, education, occupation, residence, age of marriage, special habits, history of medical diseases, surgical history and sexual history in the previous 6 months. Thorough general and local examination was also done. Routine laboratory investigations including complete blood count liver function tests renal function tests, blood sugar and lipid profiles; were done. Evaluation questionnaire used included 25 items designed by the investigators. Only some items selected from the female sexual function index (FSFI) [5], other questions were added to suit the purpose of study.

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The FSFI domain has maximum possible total scores of 36 as in (Table 1). The FSFI, a 19-item questionnaire, has been developed as a brief, multidimensional self-report instrument for assessing the key dimensions of sexual function in women. It is psychometrically sound, easy to administer, and has demonstrated ability to discriminate between clinical and nonclinical populations. The questionnaire described was designed and validated for assessment of female sexual function and quality of life in clinical trials or epidemiological studies. In addition, depression questionnaire was added to exclude the major psychological depressive disorder and its result put with the evaluation questionnaire as one item only (Table 2).

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The collected data were statistically analyzed using SPSS program (Statistical Package for Social Science) version 18.0.SPSS Inc., Chicago, IL, US. No significant differences were found between both studied groups regarding the demographic data (Table1). Also, the pretreatment baseline sexual function domains were comparable between both arms as shown in Table1. There were significant improvements in group A (the sildenafil group) particularly in the desire, lubrication, orgasm and the overall satisfaction domains (Table2).When compared to the placebo group, the treatment group was superior only in the post-treatment orgasm domain (Table 2). Sexual dysfunction is any disturbance in sexual response cycle [6].The family as the center and core of all human societies is based on the sexual instinct [7]. The improvnent in FSFI in-group A may be related to increase in androgen level as there might be a positive correlation between sildenafil intake and increase testosterone blood level [18].

• 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.

Also it increases the pelvic blood flow which may give more improvement in lubrication and decrease pain during sexual act and increase overall sexual satisfaction. [19] stated that sildenafil citrate only acts on the physical phenomena of arousal and does not completely respond to the complexity of female sexual arousal disorders (FSADs).

Materials and Methods:

Female sexual problems have not received much sildenafil citrate 120 mg attention as men’s sexual problems especially in Arab countries [8]. The current study was conducted to evaluate the effect of sildenafil citrate on the female sexual dysfunction. The included sample was composed of 52 women complaining of sexual dysfunction. They were randomized into 2 equal groups “sildenafil group and placebo group” as mentioned in the methodology section. Overall, most of patients who received sildenafil were living in urban areas (53%).

Flibanserin (Addyi)

All patients of this study were educated, varying between secondary and university levels. Well-educated women from urban areas gave accurate answers as compared to those from conservative families, rural areas with lower education because the latter suffers from lack of access to information and lower level of awareness. [9] concluded that high education level, exposure to the media, and living in modernized cities were the main contributing factors to a high awareness of reproductive health issues. Both studied groups were comparable regarding the pretreatment FSFI with its all domains. As for the unprovoked desire to have sex, no statistically significant difference between both groups was found.

Recreational use

This means that the demographic data has no particular effect on the female sexuality and both groups were at the same baseline pretreatment parameters. This agrees with the conclusion of Spector et al. [10] who tablet sildenafil 50 mg stated that the sexual desire, which is an aspect of a person’s sexuality, varies significantly from one person to another, and varies depending on the surrounding circumstances at a particular time. Comparing the effect of residence on female sexuality, the study showed higher figures in urban areas regarding coital frequency, ability to reach orgasm, overall satisfaction with sexual life, practice of premarital masturbation and knowledge about it. However, frequency of experiencing unprovoked desire seemed to be unaffected by residence. In fact, encouraging results were achieved in specific groups of patients affected by secondary FSADs (e.g., diabetes mellitus, multiple sclerosis, chronic antidepressant users) in which the genital arousal disorder is clearly connected with a neurological or vascular injury. [20] reported only lubrication changes in vaginal and clitoral sensitivity in patients treated with sildenafil. When examining the effects of sildenafil on female sexual dysfunction, it was found that sildenafil may increase congestion of the vagina, but it has no effect on excitement. This difference in results can be attributed to the manner and extent of drug administration, assessment of sexual status, and cultural status of the subjects in the study. Moreover, in most studies, the sample size has been very small, which makes their validity questionable.

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

The limitation of this study is that it was conducted on only Egyptian patients, so further well-designed studies are needed to see if the same conclusions apply to other races.