Low Dose Sildenafil (AKA Viagra®) for Women

Ours was the first study on the effects of sildenafil on clitoral blood flow in diabetic women using color Doppler ultrasound. An interesting study was conducted with healthy postmenopausal women to examine the effects of sildenafil on both clitoral and uterine blood flow by color Doppler ultrasound (35).

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Considering the order in which the treatments were allocated, data was analyzed by Student’s t-test, using the Bonferroni method of correction for multiple comparisons if a significant F ratio was found. Statistical analysis was carried out using the Primer of Biostatistics statistical computer package (29). Of the 36 women enrolled in the study, 32 women aged 27–41 with a mean age (±SD) of 33 (±3.1) and a BMI 25.0 ± 3.5 provided information at each treatment to be included in the analyses. Four women were excluded after assessment at baseline: [1] two for anovulatory cycles and [2] two for refused treatment. The mean duration of diabetes was 12.1 ± 8.5 years, and the mean HbA1c value was 8.0% ± 1.8%.

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Plasma concentrations of T (0.4 ± 0.6 ng/mL; normal range, 0.3–1.2 ng/mL), FT (1.3 ± 0.7 pg/mL; normal range, 0.3–3.2 pg/mL)19, and PRL (10.5 ± 3.5 ng/mL; normal range, 5–25 ng/mL) were normal. Moreover, 4 (12.5%) of 32 women in the B sequence did not complete the study for adverse events, all during sildenafil usage. They stopped taking the drug for [1] headache, vision problems, and nausea (n = 1), [2] vision problem and headache (n = 1), and [3] headache and nausea (n = 2). Therefore, the incidences of the most commonly recorded adverse events reported by subjects during the use of sildenafil were headache (12.5%), nausea (6.2%), and vision problem (6.2%). Each adverse event was predominantly transient and mild in nature. After sildenafil administration each mean index showed improvement in blood flow, even if the Doppler measurements of the clitoris and uterus were not equal, probably due to the dense concentration of PDE5, which is highly expressed in clitoris erectile tissue in comparison to other female genital tissues (36, 37).

• Some studies suggest sildenafil might help women with sexual arousal disorder.
• The drug's vasodilating effects can have cardiovascular implications in women.
• Women should be cautious of counterfeit or unapproved sildenafil products.
• Combining sildenafil with other ED drugs in women is not recommended without medical advice.
• Psychological support remains an important aspect of treating female sexual dysfunction.
• Ongoing clinical trials aim to establish the safety and efficacy of sildenafil for women.

Besides studying the effect of diabetes on arousal, orgasm, and desire and its role in provoking sexual pain, we took into consideration the change of sexual enjoyment and both satisfaction with and frequency of sexual activity. In contrast to previously reported data, in our study women with type 1 diabetes did not suffer from sexual desire dysfunction (6, 38, 39), which was investigated by both the SHI and the PEQ. Because diabetes produces vascular pathologies and microangiopathy, vasoactive drugs could be used to treat genital arousal dysfunction in diabetic women. recently affirmed that no single androgen level is predictive of low female sexual function and the majority of women with low DHEAS levels did not have low sexual function; however, they said that their results were not in conflict with T being used pharmacologically to treat hypoactive sexual desire disorder (HSDD): sex steroids influence female sexual function, but there is no serum androgen level that defines female androgen insufficiency (40). found no evidence of association between sexual disorders and low serum total and FT levels, in our study we included only women with normal plasma concentrations of both steroids because androgens may play an important role in modulating the physiology of vaginal tissue and contribute to female genital sexual arousal by enhancing NO synthase activity (41).

Moreover, there are several studies that showed the efficacy of androgen treatment of women affected by sexual dysfunction such as HSDD (9, 10, 40, 42).

Assessment of quality of life in subjects affected by diabetes is increasingly believed to be a crucial parameter to take into account before concluding on the efficacy of new therapies.

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Our study was the first to take into consideration type 1 diabetic women treated with sildenafil. In our pilot study, the treatment with 100 mg sildenafil was effective in modifying both sexuality and clitoral blood flow in premenopausal women with type 1 diabetes. Techniques measuring hemodynamic changes in the vagina and clitoris using clitoral tissue concentrations of hemoglobin, vaginal luminar pressure, and clitoral intracavernosal pressure could involve noninvasive instruments (8). However, we should use more direct diagnostic procedures to evaluate hemodynamic events of vaginal and clitoral pathways. The color Doppler ultrasound has become a first-level diagnostic procedure to measure the penile blood flow of men with ED (30) and might be a useful method to study the female sexual response by measuring clitoral blood flow (31).

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By color Doppler ultrasound, we observed a decreased mean RI and an increased mean PSV and PI of the clitoral artery. These changes may be due to the vasodilator effect of sildenafil on female genital tissues. Sildenafil was shown to be able to inhibit cGMP hydrolysis by high-affinity selective PDE5 inhibition in intact cells and in soluble extracts of human clitoral corpus cavernosum smooth muscle cells. Moreover, the finding of NO in human clitoral tissue (32) and vaginal tissue (33) could sustain the activity of sildenafil on female peripheral genital targets. Some interesting clinical data showed sildenafil to be effective on both premenopausal (22) and postmenopausal (23) women affected by SAD, and data on asymptomatic premenopausal women using sildenafil to study the effects of the PDE5 inhibitor on the genital pathway showed increased sexual activity, mainly in genital arousal (34). The quality of life of diabetic subjects depends on several daily aspects, among which is sexuality.

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During the study, each women had well-controlled diabetes. The mean HbA1c value obtained during each treatment was similar to that observed at baseline (P=NS). The BMI did not show any significant variation with respect to baseline values (P=NS). The sexual interview showed that the mean duration of sexual dysfunction was 3.5 years (range, 2.2–4.5 years). Subjects mainly reported arousal and orgasm difficulties and dyspareunia.

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Moreover, they reported a decrease in sexual satisfaction and in sexual activity. The mean (±SD) usage of sildenafil and placebo was, respectively, 2.1 (±0.4) and 2.9 (±0.4) times weekly. It is interesting to note that all women recorded using each drug for all sexual activities. Changes in sexuality produced by drug administrations were noticed though the analysis of PEQ items. Table 1 shows the changes from baseline of qualitative and quantitative sexual behaviors according to the treatment and the efficacy of sildenafil and placebo. The integration of clinical and psychosocial care could be helpful in both identifying subjects that need a treatment reexamination and improving the quality of life of the subject.

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The PEQ was used at baseline, at the washout, and after treatments. Arterial clitoral color Doppler ultrasound was performed at baseline and during the usage of drugs. All adverse events reported by the woman were recorded, irrespective of any random relationship with the study drug. Intention-to-treat analyses were performed for all efficacy variables and included all patients who had a baseline evaluation and had at least one efficacy assessment after the baseline visit. We included in the analysis the subjects that had missing information on one or more questionnaire items.

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The last observation carried forward was used to select data such that missing data were replaced by values from the last available assessment during treatment before the respective assessment. Furthermore, women who stopped treatment for adverse events were included in the analysis. For comparisons among baseline, sildenafil 100 mg, and placebo sexual PEQ scores, the nonparametric Wilcoxon’s rank-sum test was used. Separate analyses were performed for the arousal score (primary end point) and desire, orgasm, enjoyment of sexual activities, satisfaction with frequency, and frequency of intercourse. Paired Student’s t-test was performed to compare changes between baseline sildenafil and placebo values of clitoral arterial blood flow. Based on the results of our study, we believe that diabetic women affected by sexual dysfunction such as sexual arousal disorder could use PDE5 inhibitors.

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Data indicate that sildenafil improved [1] the experience of arousal (P<.001), orgasm (P<.001), and enjoyment (P<.001) with respect to baseline; and [2] the experience of arousal (P<.01) and orgasm (P<.05) with respect to placebo. Excluding the frequency of intercourse (P<.05), each aspect of sexuality during placebo intake was similar to that observed at baseline (P=NS). During sildenafil intake, dyspareunia decreased with respect to baseline and placebo (P<.05). Finally, desire and frequency of fantasies did not change during both treatments with respect to baseline (P=NS). All women enrolled in the study underwent baseline color Doppler ultrasound; at the end of the A sequence, 32 women (response rate, 88.9%) underwent color Doppler ultrasound, while at the end of the B sequence 28 women (response rate, 77.7%) underwent color Doppler ultrasound.

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Table 2 shows the results of the color Doppler ultrasound measurements and statistical analysis. In both the A and B sequences of drug administration, sildenafil improved clitoral blood flow with respect to placebo (P<.05). During sildenafil administration, the mean PSV (16.78 ± sildenafil oral jelly 100 mg 1.65) markedly increased and the mean EDV (−5.1 ± 1.2) significantly decreased from baseline. On the contrary, placebo was not able to produce any change with respect to baseline (P=NS). Moreover, the mean RI (0.71 ± 0.32) was significantly lower and the mean PI (1.81 ± 0.77) was significantly higher compared with both baseline and placebo values (P<.05). Sex therapists are discovering that integrating adjunctive use of the new sexual pharmaceuticals with sex therapy can accelerate the therapeutic process and improve outcome.

• Sildenafil is often known by the brand name Viagra, primarily for men.
• Researchers are exploring other PDE5 inhibitors for women’s sexual health.
• Efficacy of sildenafil in women might depend on underlying health conditions.
• Women with cardiovascular issues should be particularly cautious with sildenafil.
• Some women report increased sexual satisfaction after using sildenafil.
• Medical advice is crucial before women consider sildenafil as a treatment.

As new drugs will be developed and approved for female sexual dysfunctions, opportunities for medical and nonmedical sex therapies will increase.