Sildenafil for women patients with antidepressant-induced sexual dysfunction

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.

• Psychological support can enhance the effectiveness of medical treatments.
• Female sexual health is complex and multifaceted.
• Sildenafil should not replace comprehensive sexual health assessments.
• Evidence supports combining medication with behavioral therapies.

They were randomized into 2 equal groups “sildenafil group and placebo group” as mentioned in the methodology section.

1. How it works

Also impaired sexual function can have damaging effects on the self-esteem, sense of wholeness and interpersonal relationships of women. It is often emotionally distressing and can affect reproduction or even end up with separation or divorce [2]. Selective type 5 phosphodiesterase (PDE5) inhibitors as sildenafil, which acts by inhibiting cyclic GMP specific PDE5 may improve the sexual health of women affected by sexual difficulties such as arousal disorders and may indirectly improve other aspects of sexual life [3]. Sildenafil was effective and well-tolerated in post-menopausal women with sexual arousal disorder without concomitant hypoactive sexual desire disorder or contributory emotional relationship or historical abuse issues [4]. However, studying FSD is lacking in the literature especially in the Arab and middle east region.

J. Sex Marital Ther.

In this study, we tried to prospectively assess safety and efficacy of sildenafil citrate in treating FSD. The study was conducted in the Andrology and gynecology departments of Zagazig and Tanta University Hospitals during the period from April 2017 to August 2020. Informed consents were taken from all participants. Group A contained 26 patients who received 50mg sildenafil on demand. Group B received placebo tablets and also included 26 patients.

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The sildenafil citrate tablets for female study was prospective, double-blinded and placebo controlled. The Institutional Review Board (IRB) provided ethical approval for this study (Institutional Review Board N° 1965) for Faculty of Medicine, Zagazig University, and Zagazig, Egypt on March 3, 2017. Married female patients complaining of sexual dysfunction for at least 6 months and not on drug therapy for the treatment of FSD. Patients with sexual dysfunction caused by local genital disorder, patients with retinal problem, patients with chronic debilitating diseases or hormonal disturbance, patients who cannot be treated with PDEs inhibitors type 5(sildenafil) as: Major hematological, renal or hepatic abnormalities, patients with major psychological disorders including major depression or psychosis, a history of stroke or myocardial infarction or any significant cardiovascular disease within the last 6 months, or concomitant treatment with nitrates. 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. Overall, most of patients who received sildenafil were living in urban areas (53%).

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All patients of this study were educated, varying between secondary and university levels.

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You should carry the list with you in case of emergencies. This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use. The American Society of Health-System Pharmacists, Inc. represents that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field.

Curr. Psychiatry Rep.

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Vyleesi (Bremalontide)

does not endorse or recommend the use of any drug. The information is not a substitute for medical care. Submission: October 15, 2021; Published: February 28, 2022 *Corresponding author: Mohamed Alhefnawy, Urology department, Benha University, Egypt How to cite this article: Mohamed A, Abdulla E, Mohamed A, Mohamed E, Ahmed E, et al. Efficacy of Sildenafil Citrate on Female Sexual Dysfunction in A Sample of Egyptian Females, A Prospective Placebo Controlled Study. J Gynecol Women’s Health 2022: 23(1): 556105. Well-educated women from urban areas gave accurate answers as compared to those from conservative families, rural areas

Off-label Use	Description	Evidence Level	Caution
Treatment of Female Sexual Dysfunction	Improving desire and arousal	Limited	Not FDA-approved, consult doctor
Pulmonary Arterial Hypertension	Used in women with this condition	Approved in some countries	Under medical supervision
Erectile Dysfunction in Partner	Enhancing sexual activity indirectly	Anecdotal	Not primary use

with lower education because the latter suffers from lack of access to information and lower level of awareness.

European Journal of Obstetrics & Gynecology and Reproductive Biology

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]. Female sexual problems have not received much attention as men’s sexual problems especially in Arab countries [8]. [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.

Drug Name	Mechanism	Approval Status	Cost per Dose	Common Side Effects
Sildenafil	PDE5 inhibitor	Not officially approved	$10-$20	Headache, flushing
Tadalafil	Longer duration, PDE5 inhibitor	Limited use	$15-$30	Muscle pain, headache
Vardenafil	Similar to sildenafil	Experimental	$12-$25	Vision changes

Both studied groups were comparable regarding the pretreatment FSFI with its all domains.

Materials and Methods:

DOI: 10.19080/JGWH.2022.23.556105 Background: Sexual dysfunction is a problem that occurs during the sexual response cycle that prevents the individual from experiencing satisfaction from sexual activity. The assessment of sexual function in women is frequently confounded by many factors, including depressed mood and other comorbid medical and psychiatric disorders. Sildenafil is selective type 5 phosphodiesterase (PDE5) inhibitors, taken orally and effective for men with erectile dysfunction. Previous studies suggested that sildenafil may improve the sexual health of women affected by sexual difficulties such as arousal disorders and may indirectly improve other aspects of sexual life. Sildenafil was effective and well tolerated in postmenopausal women with sexual arousal disorder without concomitant hypoactive sexual desire disorder or contributory emotional relationship or historical abuse issues.

Anatomy and physiology of female sexual function and dysfunction: classification

Objective: This study aimed to evaluate the effect of sildenafil citrate on female sexual dysfunction. Subjects and methods: The study was conducted in the Andrology and Gynecology departments of Zagazig and Tanta University Hospitals during the period from April 2017 to August 2020. Fifty-two married female patients were included in this study. Group 1 included 26 patients, all received 50mg sildenafil on demand and group 2 included 26 patients who took placebo tablets. Results: There was no significant difference between the studied groups regarding the demographic data, and FSFI.

Exploratory Phase 2b RESPOND Study, Completed in 2023

There was significant difference between pre and post treatment of sexual dysfunction regarding the Sildenafil arm. There was no significant difference in post treatment results between the two studied groups as regard sexual dysfunction except in orgasm which showed superior improvement in the Sildenafil group. Conclusions: Sildenafil citrate seems to be effective in treating women who could not achieve orgasm. Abbreviations: FSD: Female Sexual Dysfunction; IRB: Institutional Review Board; FSFI: female sexual function index; SPSS: Statistical Package for Social Science Female Sexual Dysfunction (FSD) is a disturbance or dysfunction in the process of desire, arousal or orgasm, which can be a symptom of a biological condition, a psychological problem, an interpersonal issue or a combination of these factors [1]. Female Sexual Dysfunction is a multi-causal and a multi- dimensional medical problem that adversely affects physical health & emotional wellbeing. As for the unprovoked desire to have sex, no statistically significant difference between both groups was found.

• Future studies may clarify sildenafil’s effectiveness for women.
• Regulatory approval for women may be granted if proven safe.
• Personalized medicine approaches could enhance treatment outcomes.
• In the meantime, women should seek professional advice before 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.

3. Downsides

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. The FSFI domain has maximum possible total scores of 36 as in (Table 1).

Competing interests

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). The collected data were statistically analyzed using SPSS program (Statistical Package for Social Science) version 18.0.SPSS Inc., Chicago, IL, US.