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In the flexible dose-escalation study, 329 different men were randomly assigned to take placebo

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The protocols were approved by the institutional review board at each center, and all the men gave written informed consent. We assessed efficacy by using the responses to question 3 (frequency of penetration) and question 4 (maintenance of erections after penetration) of the 15-question International Index of Erectile Function, a validated, multidimensional, self-administered questionnaire used for the clinical assessment of erectile dysfunction and treatment outcomes in clinical studies.11 The responses to these two questions pertaining to the ability to achieve and maintain an erection sufficient for sexual intercourse, as described in the definition of erectile dysfunction,1 were rated on a scale of 1 (almost never or never) to 5 (almost always or always). A score of 0 indicated no attempt at sexual intercourse. The mean score for each of the two questions was 4.3 for 109 normal men, 31 to 86 years old, with an age distribution similar to that of the men with erectile dysfunction (unpublished data). Efficacy was also assessed on the basis of the scores for the five separate response domains of male sexual function of the International Index13: erectile function (questions 1 through 5 and 15; possible total score, 1 to 30); orgasmic function (questions 9 and 10; possible total score, 0 to 10); sexual desire (questions 11 and 12; possible total score, 2 to 10); intercourse satisfaction (questions 6, 7, and 8; possible total score, 0 to 15); and overall satisfaction (questions 13 and 14; possible total score, 2 to 10).

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The domain scores were computed by adding the scores for the individual questions in each domain. Other means of assessing efficacy were an event log, in which we asked the men to record the date and dose of medication taken, the presence of sexual stimulation, the hardness of erections (graded sildenafil citrate 200mg price on a four-point scale), and whether sexual intercourse was successful, and a global-efficacy question (“Did the treatment improve your erections?”), with a response of yes or no. The end points of the International Index quantified the magnitude of the response, and the global-efficacy question and the event log provided qualitative assessments of efficacy. Physical examinations and standard blood-chemistry and hematologic laboratory tests were performed throughout the studies. Adverse effects were recorded by the investigators. or 50 mg of sildenafil approximately one hour before sexual activity for 12 weeks.

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At each follow-up visit, the dose could be doubled or reduced by 50 percent on the basis of the therapeutic response and adverse effects.

Precaution/Contraindication	Explanation	Recommendations
Use with Nitrates	Can cause severe hypotension	Avoid concomitant use
Cardiac conditions	Potential stress on cardiovascular system	Consult healthcare provider
Recent Stroke or Heart Attack	Increased risk of adverse events	Medical evaluation required
Liver or Kidney Impairment	Altered drug metabolism	Dose adjustments needed
Sensitive to Sildenafil	Allergic reactions or hypersensitivity	Discontinue if adverse reactions occur

Each man completed the International Index of Erectile Function at 0 and 12 weeks and was asked about global efficacy at week 12.

• Sildenafil 50 mg is effective for most men within 30 minutes.
• Duration of effect lasts about 4-6 hours.
• It does not cause an erection without sexual stimulation.
• The medication does not protect against sexually transmitted diseases.
• Report any adverse reactions to your healthcare provider.
• Do not combine sildenafil with recreational drugs like poppers.
• Regular use may improve sexual performance over time.
• Always check for allergies before use.

The event logs were reviewed at 0, 2, 4, 8, and 12 weeks.

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Sildenafil is rapidly absorbed, with maximal plasma concentrations occurring within one hour after oral administration and a mean terminal half-life of three to five hours.10 In a placebo-controlled pilot study of 12 men, sildenafil significantly improved the erectile response during visual sexual stimulation.10,12 We therefore undertook two studies to evaluate in a home setting the efficacy and safety of sildenafil in men with erectile dysfunction. In two sequential studies, we studied a total of 861 men 18 years of age or older with a clinical diagnosis of erectile dysfunction (as defined previously1) of six months' duration or longer at 37 centers in the United States. Each man had to be in a stable relationship with a female partner that had begun at least six months earlier. The cause of erectile dysfunction was determined from the medical history, physical examination, and other diagnostic procedures, including a test involving the intracavernosal injection of a vasoactive drug (done in 31 percent of the men), a RigiScan test of nocturnal penile tumescence (26 percent), penile duplex ultrasonography (21 percent), and endocrine testing (21 percent). On the basis of these evaluations, the men were classified as having organic, psychogenic, or mixed erectile dysfunction.

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Of the 861 men studied, 605 (70 percent) were judged to have organic erectile dysfunction, 99 (11 percent) to have psychogenic erectile dysfunction, and 157 (18 percent) to have mixed erectile dysfunction. Men were excluded if they had penile anatomical defects, a primary diagnosis of another sexual disorder (e.g., premature ejaculation), spinal cord injury, any major psychiatric disorder not well controlled with treatment, poorly controlled diabetes mellitus, active peptic ulcer disease, a history of alcohol or substance abuse, major hematologic, renal, or hepatic abnormalities, or a recent (within the previous six months) stroke or myocardial infarction or if they were receiving nitrate therapy. Other erectile-dysfunction therapies were discontinued at the time of screening (four weeks before the subjects received the study medication). Sildenafil (Viagra) and an identical-looking placebo were supplied by Pfizer. The men were instructed to take a dose approximately one hour before planned sexual activity but not more than once daily. The men who completed the study and who did not have any serious

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adverse effects were eligible to receive open-label sildenafil for an additional 32 weeks.

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Should I take a lower dosage of Viagra because of my other medications? Would a higher dosage of Viagra increase my risk for side effects? To learn more about Viagra, see these articles: Disclaimer: Healthline has made every effort to make certain that all information is factually correct, comprehensive, and up to date. We evaluated the efficacy and safety of sildenafil, administered as needed in two sequential double-blind studies of men with erectile dysfunction of organic, psychogenic, or mixed causes. In a 24-week dose–response study, 532 men were treated with oral sildenafil (25, 50, or 100 mg) or placebo.

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In a 12-week, flexible dose-escalation study, 329 different men were treated with sildenafil or placebo, with dose escalation to 100 mg based on efficacy and tolerance. After this dose-escalation study, 225 of the 329 men entered a 32-week, open-label extension study. We assessed efficacy according to the International Index of Erectile Function, a patient log, and a global-efficacy question. In the dose–response study, increasing doses of sildenafil were associated with improved erectile function (P values for increases in scores for questions about achieving and maintaining erections were <0.001). For the men receiving 100 mg of sildenafil, the mean score for the question about achieving erections was 100 percent higher after treatment than at base line (4.0 vs. The mean frequency of responses to questions 3 and 4 of

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In this double-blind, placebo-controlled, fixed-dose study, 532 men were randomly assigned to take placebo or 25, 50, or 100 mg of sildenafil (approximately one hour before planned sexual activity but not more than once daily) for 24 weeks. Each dose consisted of three tablets from the same row of a blister pack (placebo–placebo–placebo; placebo–placebo–25 mg; placebo–placebo–50 mg; or placebo–50 mg–50 mg). The men were instructed not to consume more than two alcoholic drinks within one hour of sexual activity. Each man completed the International Index of Erectile Function at 0, 12, and 24 weeks and was asked about global efficacy at 12 and 24 weeks. The event logs were reviewed at 0, 2, 4, 8, 12, 16, 20, and 24 weeks. the International Index of Erectile Function for each treatment group was calculated.

• Sildenafil 50 mg tablets are used to treat erectile dysfunction.
• The medicine improves blood flow to the penis.
• Take sildenafil 50 mg 30-60 minutes before activity.
• Do not exceed one tablet per 24 hours.
• Common side effects include headache and flushing.
• Avoid consuming high-fat meals before taking it.
• Alcohol may reduce the effectiveness of the medication.
• Consult a doctor if you experience prolonged erections.

An analysis-of-covariance model was fitted for each question, which

• Sildenafil 50 mg tablets should be stored away from moisture.
• Do not alter the dosage prescribed by your doctor.
• Men with optic conditions should exercise caution.
• Be aware of the risk of sudden hearing loss.
• Use only as directed by healthcare providers.
• Keep track of medication expiration dates.
• The drug works best when taken on an empty stomach.
• Always inform your doctor of any new symptoms.

included main-effect terms for investigational center and treatment effect

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2.0 of a possible score of 5). In the last four weeks of treatment in the dose-escalation study, 69 percent of all attempts at sexual intercourse were successful for the men receiving sildenafil, as compared with 22 percent for those receiving placebo (P<0.001). The mean numbers of successful attempts per month were 5.9 for the men receiving sildenafil and 1.5 for those receiving placebo (P<0.001). Headache, flushing, and dyspepsia were the most common adverse effects in the dose-escalation study, occurring in 6 percent to 18 percent of the men. Ninety-two percent of the men completed the 32-week extension study.

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Oral sildenafil is an effective, well-tolerated treatment for men with erectile dysfunction. Erectile dysfunction, the persistent inability to achieve or maintain an erection sufficient for satisfactory sexual performance, is estimated to affect up to 30 million men in the United States.1 The disorder is age-associated,1–3 with estimated prevalence rates of 39 percent among men 40 years old and 67 percent among those 70 years old.2 The available treatments include vacuum-constriction devices; intracavernosal injections of vasoactive agents, including alprostadil (prostaglandin E1)4; transurethral delivery of alprostadil5; implantation of penile prostheses; and venous or arterial surgery. No effective oral therapy for erectile dysfunction is currently available.6 Normal penile erection depends on the relaxation of smooth muscles in the corpora cavernosa. In response to sexual stimuli, cavernous nerves and endothelial cells release nitric oxide, which stimulates the formation of cyclic guanosine monophosphate (GMP) by guanylate cyclase.7–9 The mechanism by which cyclic GMP stimulates relaxation of the smooth muscles remains to be elucidated. Sildenafil is a selective inhibitor of cyclic-GMP–specific phosphodiesterase type 5, the predominant isozyme metabolizing cyclic GMP in the corpus cavernosum.10 By selectively inhibiting cyclic-GMP catabolism in cavernosal smooth-muscle cells,11 sildenafil would be expected to restore the natural erectile response to sexual stimulation but not cause erections in the sildenafil oral jelly 100mg absence of such stimulation. (as ordered categorical variables), with base-line score, patient age, smoking, and duration and cause of erectile dysfunction as covariates.

Use Case	Description	Typical Dosage	Notes
Erectile Dysfunction	Improve erectile response during sexual activity	50 mg as needed	Taken 30-60 min before activity
Pulmonary Arterial Hypertension	Off-label use to reduce blood pressure in lungs	Under medical supervision	Brand: Revatio
Off-label uses	Possible off-label benefits in other circulatory disorders	Under research	Not generally approved