Safety and Efficacy of Sildenafil Citrate for the Treatment of Female Sexual Arousal Disorder: A Double-Blind, Placebo Controlled Study

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 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. 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.

• Female sexual dysfunction affects many women worldwide.
• Medical research continues to explore effective treatments.
• Sildenafil's role remains experimental for many women.
• Consultation with specialists is recommended for personalized care.

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.

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]. 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). 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.

• Sildenafil can enhance arousal in women with sexual issues.
• It works by relaxing blood vessels, increasing genital blood flow.
• Dosage for women is not well established; consult a doctor.
• Its effectiveness varies among women with sexual dysfunction.

[20] reported only lubrication changes in vaginal and clitoral sensitivity in patients treated with sildenafil.

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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).

Curr. Opin. Neurobiol.

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). 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.

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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).

How much time does it take for Viagra to work for females?

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].

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Female sexual problems have not received much 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%). 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. On the other hand, points of strength include among others, the good sample size and the prospective randomized double-blinded study design.

• Sildenafil is being studied for female sexual dysfunction.
• It may improve blood flow to vaginal tissues.
• Not officially approved for women in many countries.
• Side effects can include headaches and flushing.

Sildenafil citrate seems to improve orgasm in a sample of Egyptian females with sexual dysfunction.

• Sildenafil’s interaction with other medications is an important consideration.
• It has a different impact depending on individual health conditions.
• Data on long-term effects of sildenafil in women are inconclusive.
• Use only under medical supervision to minimize risks.

Desilva P (1995) Sexual dysfunction in S.J.E Lindsay and G.E.Powell, The hand book of lineal and adult psychology.

London and New York rout ledge (2): 199-288.

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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.

Biochemical Factors Modulating Female Genital Sexual Arousal Physiology

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 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.

Int. J. Impot. Res.

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. Jaafapour M, Khani A, Khajavikhan J, Suhrabi Z (2013) Female sexual dysfunction, prevalence and risk factor and Journal of clinical and diagnostic research 7(12): 2877-2880.

Efficacy of Sildenafil Citrate on Female Sexual Dysfunction in A Sample of Egyptian Females, A Prospective Placebo Controlled Study

Indeed these sildenafil tablets lp 100 mg results were opposite to the study of Dasgupta et al. [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. 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. (2006) Sildenafil improve sexual functioning in premenopausal women with type 1 diabetes who are affected by sexual arousal disorder.