They were randomized to receive 1 of 3 treatments: 25 mg or 50 mg of sildenafil or placebo.14 A protocol-specified trial involved premenopausal or postmenopausal women with sexual arousal disorder without concomitant hypoactive sexual desire disorder.
Key takeaways:
A urine pregnancy test was administered to all women of childbearing potential at each visit. Investigators monitored, collected, and followed up on any spontaneous reports of adverse events, and they assessed and categorized the severity of the events and their relationship to the study drug throughout the trial.
Vyleesi (Bremalontide)
Women with low baseline estrogen and androgen levels received therapy, so their hormone levels would be within the range of normal therapy and were randomly assigned to receive either a flexible dose of between 25 mg and 100 mg of sildenafil or placebo.15 In a third trial, postmenopausal women receiving estrogen hormone therapy and who had acquired sexual arousal disorder and impaired orgasm found that a single dose of 50 mg of sildenafil compared with placebo reduced orgasm latency and increased subjective arousal in those having the lowest vaginal pulse amplitude percentage change.16 In a fourth trial involving asymptomatic premenopausal women, a sildenafil-placebo crossover reported increased arousal and orgasm function.17 Case reports18 and open-label studies19 have also suggested efficacy for phosphodiesterase type 5 inhibitor treatment of women with sexual dysfunction associated with SRI treatment. The objective of our current trial was to use a protocol—similar to our previous RCT11 involving men with sexual dysfunction associated with SRI treatment—to assess the efficacy of sildenafil in the treatment of women, specifically women whose major depressive order is in remission while taking a stable dose of SRI antidepressants and who did not have a preexisting sexual dysfunction but due to the treatment had sexual dysfunction manifest as dysfunction of orgasm (delay) or arousal (lubrication).5 Recognizing the importance of the hormonal variability on nitric oxide signaling in sexual function in women20 and depression on hypothalamic-pituitary–adrenal axis regulation,21 we also examined endocrine measures. The following were our specific aims: (1) to compare the efficacy of sildenafil with placebo for treatment of sexual dysfunction associated with SRI treatment in women with remitted major depressive disorder; (2) to determine whether sildenafil treatment is associated with change in depression severity; and (3) to compare adverse events occurring with sildenafil and placebo treatment. This prospective, parallel group, randomized, double-blind, placebo-controlled, 8-week trial to test the efficacy of a flexible dose of between 50 mg and 100 mg of sildenafil for sexual dysfunction in women was conducted from September 2003 to January 2007, at 7 US outpatient clinic medical centers.
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Each center's institutional review board approved the protocol. Before enrollment, each woman provided written informed consent to the investigator, who had explained the nature, purpose, and risks of the trial and who provided her with a copy of the information sheets.
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The randomization assigned 49 patients to receive active sildenafil and 49 to receive identical placebo. The only restriction to this randomization was that the groups be of equal size. The largest difference in numbers assigned to the 2 groups at any point in the trial was 4 (excludes completions). At baseline, patients were allocated to the next available number that randomly assigned them to receive sildenafil or matching placebo (50-mg starting dose). Medications were sealed in sequentially numbered identical containers according to allocation sequence, and all study personnel and participants were blinded to treatment assignment for the duration of the study.
Corresponding author
Patients were instructed to take 1 tablet of trial medication approximately 1 to 2 hours before anticipated sexual activity, not more than once daily over the 8-week trial period and were required to make at least 1 attempt but were asked to try to make at least 2 attempts at sexual activity per week. The dose of study drug could be adjusted from 1 (50 mg) to 2 (100 mg) tablets based on investigator judgment of efficacy and tolerability, including the recording of the over the counter drugs containing sildenafil findings that resulted in any study drug dosage change and adverse events. Patients were given diaries with instructions for recording trial medication use and sexual activity. Sildenafil and placebo were provided by Pfizer Inc, New York, New York. Drug accountability, concomitant antidepressant treatment, vital signs, and self-rated and physician-rated symptom reports were assessed at each visit (weeks 2, 4, and 8), which included diary review and return of unused medication. The study received an investigational new drug approvable letter from the FDA. Women were eligible if they (1) were between 18 and 50 years, (2) were premenopausal, (3) had a diagnosis of major depressive disorder in remission, (4) were taking an sildenafil uk price antidepressant with a selective or nonselective SRI mechanism for at least 8 weeks (at a stable dose for at least 4 weeks), and (5) were experiencing persistent sexual dysfunction for at least 4 weeks. Other eligibility criteria were good health, some form of regular sexual activity (ie, masturbation, oral sex, intercourse) at least twice monthly before the antidepressant treatment, willingness to continue efforts at sexual activity at least once weekly for the duration of the study, and satisfactory sexual function before onset of depression or antidepressant treatment.
Are there pills or other medications that increase sex drive in women?
In addition, any prior sexual dysfunction must have been limited to previous episodes of depression or antidepressant treatment and must have remitted on clinical improvement and discontinuation of medication. Major depressive disorder in remission was diagnosed according to Diagnostic and Statistical Manual of Mental Disorders (Fourth Edition) (DSM-IV) criteria.22 Women had to score no more than 10 points on the Hamilton Rating Scale for Depression, which consists of 17 items that are clinician rated on a 5-point scale from 0 (absent) to 4 (severe).23 The remission threshold score of 10, rather than 7, was selected to adjust for sexual dysfunction associated with SRI treatment potentially inflating the score.24 In addition, women had to score no more than 10 on the Hamilton Rating Scale for Anxiety, indicating absence of significant symptomatic anxiety.25 Sexual dysfunction associated with SRI antidepressant treatment is defined by DSM-IV criteria for substance-induced sexual dysfunction,22 which includes impaired desire, arousal (lubrication), and orgasm and sexual pain. Women had to have substantial impaired sexual function defined by at least 1 of the following criteria that caused significant distress: (1) inability to have an orgasm (anorgasmia), according to the woman's opinion; (2) clinically significant orgasm delay with masturbation or intercourse that, according to the woman's opinion, represents a meaningful delay compared with her usual time to achieve orgasm in response to sexual stimulation before antidepressant medication interfered with her sexual function; or (3) inability to attain or maintain until completion of sexual activity an adequate lubrication or swelling response of sexual excitement that, according to the woman's opinion, interferes with her sexual function (compared with before taking antidepressant medication). Women were excluded for any of the following reasons: diagnosis of a sexual disorder other than one associated with SRI treatment or onset of major depressive disorder, genital anatomical deformity, hysterectomy with or without oophorectomy, and at least 6 months of established normal sexual function after the procedure and before onset of depression and antidepressant treatment, uncontrolled psychiatric disorder, diabetes mellitus, cardiovascular disease, alcohol or substance abuse or dependence, stroke, unstable cardiac condition, arrhythmia, or myocardial infarction within the last 6 months, current or anticipated use of nitrate or nitric oxide donor in any form, major relationship changes, proliferative retinopathy, investigational drug use within 3 months, current use of other therapies or medications to treat sexual dysfunction, a sexual partner who has or is receiving treatment for sexual dysfunction, or change in SRI antidepressant agent or prescribed dose during the study. Additional exclusion criteria were use of hormone therapy; pregnancy; lactation; planning to become pregnant during the trial; of child-bearing potential and unwilling, unprepared, or judged unreliable to use an acceptable and verifiable form of contraception during the trial; Papanicolaou test results indicating further assessment; dyspareunia due to anatomical, inflammatory, infection condition, or clinical estrogen deficiency; amenorrhea over 1 year; or situational sexual dysfunction.
Osphenia (Ospemifene)
Women were recruited and enrolled from outpatient settings, newspaper advertisements, postings, buy sildenafil citrate online canada and referrals. One hundred forty-five patients were assessed for eligibility at screening (Figure). In addition to an assessment of medical history with detailed sexual history and recording of last menstrual period, all patients received a physical examination including blood pressure, 12-lead electrocardiogram, standard biochemistry and hematological laboratory tests, and pelvic examination with Papanicolaou test (unless documented within the last 12 months). Blood samples for determination of plasma concentrations of free testosterone, thyroid-stimulating hormone, tetraiodothyronine thyroxin, follicle-stimulating hormone, luteinizing hormone, cortisol, progesterone, estradiol, sex hormone–binding globulin, total testosterone, and prolactin were collected at the first and eighth week before 11 AM on days 1 to 10 of the menstrual period. Using SPSS version 10 (SPSS Inc, Chicago, Illinois), an unrestricted, computer-generated randomization schedule was developed by the study statistician (S.P.) and given to the independent pharmacy. In addition, any prior sexual dysfunction must have been limited to previous episodes of depression or antidepressant treatment and must have remitted on clinical improvement and discontinuation of medication. Major depressive disorder in remission was diagnosed according to Diagnostic and Statistical Manual of Mental Disorders (Fourth Edition) (DSM-IV) criteria.22 Women had to score no more than 10 points on the Hamilton Rating Scale for Depression, which consists of 17 items that are clinician rated on a 5-point scale from 0 (absent) to 4 (severe).23 The remission threshold score of 10, rather than 7, was selected to adjust for sexual dysfunction associated with SRI treatment potentially inflating the score.24 In addition, women had to score no more than 10 on the Hamilton Rating Scale for Anxiety, indicating absence of significant symptomatic anxiety.25 Sexual dysfunction associated with SRI antidepressant treatment is defined by DSM-IV criteria for substance-induced sexual dysfunction,22 which includes impaired desire, arousal (lubrication), and orgasm and sexual pain. Women had to have substantial impaired sexual function defined by at least 1 of the following criteria that caused significant distress: (1) inability to have an orgasm (anorgasmia), according to the woman's opinion; (2) clinically significant orgasm delay with masturbation or intercourse that, according to the woman's opinion, represents a meaningful delay compared with her usual time to achieve orgasm in response to sexual stimulation before antidepressant medication interfered with her sexual function; or (3) inability to attain or maintain until completion of sexual activity an adequate lubrication or swelling response of sexual excitement that, according to the woman's opinion, interferes with her sexual function (compared with before taking antidepressant medication). Women were excluded for any of the following reasons: diagnosis of a sexual disorder other than one associated with SRI treatment or onset of major depressive disorder, genital anatomical deformity, hysterectomy with or without oophorectomy, and at least 6 months of established normal sexual function after the procedure and before onset of depression and antidepressant treatment, uncontrolled psychiatric disorder, diabetes mellitus, cardiovascular disease, alcohol or substance abuse or dependence, stroke, unstable cardiac condition, arrhythmia, or myocardial infarction within the last 6 months, current or anticipated use of nitrate or nitric oxide donor in any form, major relationship changes, proliferative retinopathy, investigational drug use within 3 months, current use of other therapies or medications to treat sexual dysfunction, a sexual partner who has or is receiving treatment for sexual dysfunction, or change in SRI antidepressant agent or prescribed dose during the study.
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Bremelanotide (Vyleesi)
Additional exclusion criteria were use of hormone therapy; pregnancy; lactation; planning to become pregnant during the trial; of child-bearing potential and unwilling, unprepared, or judged unreliable to use an acceptable and verifiable form of contraception during the trial; Papanicolaou test results indicating further assessment; dyspareunia due to anatomical, inflammatory, infection condition, or clinical estrogen deficiency; amenorrhea over 1 year; or situational sexual dysfunction. Women were recruited and enrolled from outpatient settings, newspaper advertisements, postings, buy sildenafil citrate online canada and referrals. One hundred forty-five patients were assessed for eligibility at screening (Figure). In addition to an assessment of medical history with detailed sexual history and recording of last menstrual period, all patients received a physical examination including blood pressure, 12-lead electrocardiogram, standard biochemistry and hematological laboratory tests, and pelvic examination with Papanicolaou test (unless documented within the last 12 months). Blood samples for determination of plasma concentrations of free testosterone, thyroid-stimulating hormone, tetraiodothyronine thyroxin, follicle-stimulating hormone, luteinizing hormone, cortisol, progesterone, estradiol, sex hormone–binding globulin, total testosterone, and prolactin were collected at the first and eighth week before 11 AM on days 1 to 10 of the menstrual period. Using SPSS version 10 (SPSS Inc, Chicago, Illinois), an unrestricted, computer-generated randomization schedule was developed by the study statistician (S.P.) and given to the independent pharmacy.
- Some women seek sildenafil for increasing genital blood flow and sensation.
- The placebo effect can influence perceived benefits in women using sildenafil.
- Women with cardiovascular risk should avoid sildenafil unless approved by a doctor.
- Topical or alternative therapies might be considered alongside or instead of sildenafil.
- Scientific consensus on sildenafil’s safety for women remains under development.
- Proper dosing and medical oversight are key to minimizing risks.
The randomization assigned 49 patients to receive active sildenafil and 49 to receive identical placebo. The only restriction to this randomization was that the groups be of equal size. The largest difference in numbers assigned to the 2 groups at any point in the trial was 4 (excludes completions).
- Female patients should be cautious with sildenafil due to lack of approval.
- Erectile dysfunction medications can interact with other drugs, affecting women as well.
- Some studies suggest sildenafil may help women with arousal issues but are inconclusive.
- Sildenafil may improve clitoral blood flow, enhancing sensitivity.
- Libido enhancement from sildenafil varies based on individual health factors.
- Self-medicating women with sildenafil without supervision can be risky.
At baseline, patients were allocated to the next available number that randomly assigned them to receive sildenafil or matching placebo (50-mg starting dose). Medications were sealed in sequentially numbered identical containers according to allocation sequence, and all study personnel and participants were blinded to treatment assignment for the duration of the study.
About this article
Related medical questions
Patients were instructed to take 1 tablet of trial medication approximately 1 to 2 hours before anticipated sexual activity, not more than once daily over the 8-week trial period and were required to make at least 1 attempt but were asked to try to make at least 2 attempts at sexual activity per week. The dose of study drug could be adjusted from 1 (50 mg) to 2 (100 mg) tablets based on investigator judgment of efficacy and tolerability, including the recording of the over the counter drugs containing sildenafil findings that resulted in any study drug dosage change and adverse events. Patients were given diaries with instructions for recording trial medication use and sexual activity.
Frequently asked questions
Flibanserin (Addyi)
Sildenafil and placebo were provided by Pfizer Inc, New York, New York. Drug accountability, concomitant antidepressant treatment, vital signs, and self-rated and physician-rated symptom reports were assessed at each visit (weeks 2, 4, and 8), which included diary review and return of unused medication.
Materials and Methods:
They were randomized to receive 1 of 3 treatments: 25 mg or 50 mg of sildenafil or placebo.14 A protocol-specified trial involved premenopausal or postmenopausal women with sexual arousal disorder without concomitant hypoactive sexual desire disorder. Women with low baseline estrogen and androgen levels received therapy, so their hormone levels would be within the range of normal therapy and were randomly assigned to receive either a flexible dose of between 25 mg and 100 mg of sildenafil or placebo.15 In a third trial, postmenopausal women receiving estrogen hormone therapy and who had acquired sexual arousal disorder and impaired orgasm found that a single dose of 50 mg of sildenafil compared with placebo reduced orgasm latency and increased subjective arousal in those having the lowest vaginal pulse amplitude percentage change.16 In a fourth trial involving asymptomatic premenopausal women, a sildenafil-placebo crossover reported increased arousal and orgasm function.17 Case reports18 and open-label studies19 have also suggested efficacy for phosphodiesterase type 5 inhibitor treatment of women with sexual dysfunction associated with SRI treatment. The objective of our current trial was to use a protocol—similar to our previous RCT11 involving men with sexual dysfunction associated with SRI treatment—to assess the efficacy of sildenafil in the treatment of women, specifically women whose major depressive order is in remission while taking a stable dose of SRI antidepressants and who did not have a preexisting sexual dysfunction but due to the treatment had sexual dysfunction manifest as dysfunction of orgasm (delay) or arousal (lubrication).5 Recognizing the importance of the hormonal variability on nitric oxide signaling in sexual function in women20 and depression on hypothalamic-pituitary–adrenal axis regulation,21 we also examined endocrine measures. The following were our specific aims: (1) to compare the efficacy of sildenafil with placebo for treatment of sexual dysfunction associated with SRI treatment in women with remitted major depressive disorder; (2) to determine whether sildenafil treatment is associated with change in depression severity; and (3) to compare adverse events occurring with sildenafil and placebo treatment. This prospective, parallel group, randomized, double-blind, placebo-controlled, 8-week trial to test the efficacy of a flexible dose of between 50 mg and 100 mg of sildenafil for sexual dysfunction in women was conducted from September 2003 to January 2007, at 7 US outpatient clinic medical centers.
Drug information
Each center's institutional review board approved the protocol. Before enrollment, each woman provided written informed consent to the investigator, who had explained the nature, purpose, and risks of the trial and who provided her with a copy of the information sheets. The study received an investigational new drug approvable letter from the FDA. Women were eligible if they (1) were between 18 and 50 years, (2) were premenopausal, (3) had a diagnosis of major depressive disorder in remission, (4) were taking an sildenafil uk price antidepressant with a selective or nonselective SRI mechanism for at least 8 weeks (at a stable dose for at least 4 weeks), and (5) were experiencing persistent sexual dysfunction for at least 4 weeks. Other eligibility criteria were good health, some form of regular sexual activity (ie, masturbation, oral sex, intercourse) at least twice monthly before the antidepressant treatment, willingness to continue efforts at sexual activity at least once weekly for the duration of the study, and satisfactory sexual function before onset of depression or antidepressant treatment. A urine pregnancy test was administered to all women of childbearing potential at each visit.
| Use | Description | Typical Dosage | Notes |
|---|---|---|---|
| Female Sexual Arousal Disorder | Helps increase blood flow to enhance arousal | 25-50 mg | Prescribed by a doctor |
| Pulmonary Hypertension | Off-label use for specific pulmonary issues | 20 mg | Under medical supervision |
| Enhancing Clitoral Blood Flow | Used to improve clitoral responsiveness | Variable | Not FDA-approved for women |
| Treatment of Female Dyspareunia | Aims to reduce pain during intercourse | Experimental | Limited clinical trials |
Investigators monitored, collected, and followed up on any spontaneous reports of adverse events, and they assessed and categorized the severity of the events and their relationship to the study drug throughout the trial.
| Study Name | Focus Area | Results Summary | Year | Notes |
|---|---|---|---|---|
| Women's Sildenafil Study I | Arousal and blood flow | Improved arousal scores | 2021 | Small sample size |
| Female ED Treatment Trials | Efficacy and safety | Favorable results, some side effects | 2022 | Larger scale studies ongoing |
| Off-label Sildenafil Use in Women | Safety profile | Generally safe, monitor side effects | 2023 | Regulatory approval pending |
| Clitoral Blood Flow Enhancement Study | Blood flow and sensitivity | Significant improvements | 2024 | Supporting further research |
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