Each woman received each treatment for 8-week periods. There was a 7-day washout period between treatments. We chose a 1-week washout period on the basis of our previous studies using a similar intervention by which we did not observe any carryover effect (22, 34). The PEQ was used at baseline, at the washout, and after treatments.

• 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.

Arterial clitoral color Doppler ultrasound was performed at baseline and during the usage of drugs.

• 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.

All adverse events reported by the woman were recorded, irrespective of any random relationship with the study drug.

Key takeaways:

The women with acquired sexual dysfunction and SAD were the focus of our study. Finally, one of our hypotheses was that if arousal were enhanced, orgasm could possibly be facilitated. To measure sexuality we used the Personal Experiences Questionnaire (PEQ) (27), a self-reporting questionnaire based on the McCoy Female Sexuality Questionnaire (28). Using the PEQ, it was possible to assess the efficacy of each treatment with respect to baseline values. Qualitative items were answered on a 5-point Likert scale, ranging from 1, not at all, to 5, a great deal.

Setting and Sample

Quantitative items were answered as 0, never; 1, less than once a week; 2, once or twice a week; 3, several times a week; 4, once a day/sometimes twice; and 5, several times a day. The PEQ was completed by each woman and handed back to the fieldworker. Finally, each woman underwent color Doppler ultrasound to measure clitoral blood flow. Ultrasound was performed using a SonoAce 8800 (Medison Co., Seoul, Korea) with a 7.5-MHz linear transducer by the same investigator. Each woman was scanned in the gynecological position.

Though you cannot place an order quite yet...

The Doppler translabial probe was placed sagittally on the clitoris at an angle of <20 degrees, without exerting any significant pressure on the tissues. After identifying the clitoral artery using color flow mapping, the Doppler probe was positioned over the vessel and at least three sequential Doppler waveforms were obtained. The peak systolic velocity (PSV), the end diastolic velocity (EDV), the resistance index (RI = PSV − EDV/PSV), and the pulsatility index (PI = PSV − EDV/mean flow velocity of clitoral artery) were calculated. A double-blind, crossover, placebo-controlled study design was performed. The efficacy of treatment was the primary end point based on the proportion of successful attempts, defined as sexual arousal levels, occurring after dosing. 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.

Frequently asked questions

Safety was considered a further end point of this study, data being collected throughout the study period, and included recording adverse events, vital signs, and changes in laboratory test values for standard hematology and biochemistry variables. Patients provided information recorded on diary cards and were reviewed at each study visit concerning sexual activity. After defining inclusion criteria at the screening, according to a computer-generated list of random number groups, each woman sildenafil citrate 150 mg red pill was randomly allocated to one of the two possible sequences, each of which constituted two medication series: sildenafil 100 mg/placebo (A sequence) and placebo/sildenafil 100 mg (B sequence). Women were assessed before being treated and during each treatment by one investigator. Both the woman and the attending doctor carrying out the procedure were blinded to the two drugs.

Sexual Function after Spinal Cord Injury: Innervation, Assessment, and Treatment

The investigator was not involved in the recruitment of the women and did not know the computer-generated randomization list and the assignment of the treatment group according to the sequence of recruitment. The codes were broken after the study was completed. The crossover study design was used to define whether the treatment with sildenafil was effective with respect to placebo. Each woman took sildenafil or placebo 1 hour before each sexual intercourse. The usage of the drug was not more than once daily. 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.

• Doctors may prescribe sildenafil off-label for women based on individual assessment.
• Patient education about realistic expectations is essential when using sildenafil.
• Sildenafil’s mechanism involves enhancing nitric oxide signaling in blood vessels.
• Women with liver or kidney problems need careful evaluation before sildenafil use.
• Viagra was initially tested for women before focusing on men’s erectile issues.
• Alternative options like vaginal lubricants are also common for female sexual problems.

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.

Medical uses

To confirm the ovulatory cycle, ultrasound was performed on days 10, 12, and 15 of the cycle and serum P concentrations were measured at days 21 and 25 of the cycle. Menstrual cycle was defined as ovulatory when the serum P was >18 IU/mL. The P level was measured using commercially available enzyme-linked immunoassorbent assay (ELISA) kits (Elecsys System 2010; Roche, Monza, Italy). Moreover, during the screening period subjects underwent a physical examination, including assessment of vital signs and an ECG. A venous blood sample was collected on the day of enrollment to determine hemoglobin glycosylated (HbA1c).

A note about sex and gender

HbA1c was determined using the Cobas Integra assay (Roche, Basel, Switzerland), where the normal rage is 4.0%–6.0%. Subjects with HbA1c ≥10% were excluded from sildenafil products over the counter the study because they were considered to be affected by diabetes that was not well-controlled. Blood samples were obtained from all study participants to measure hormonal levels of T, FT, and PRL. Hormones were sampled during the morning on cycle days 12–17. Plasma T and PRL were measured using commercially available ELISA kits (Elecsys Systems 2010).

Flibanserin (Addyi)

Plasma levels of FT were also measured using ELISA kits (DSX System; DRG Instruments GmbH, Marburg/Lahn, Germany). Each woman underwent a Sexual History Interview (SHI) (24) that was conducted in a private room alone with the female sexual disorder therapist: 60–90 minutes were needed for the interview, and 15–30 minutes to write the justification. Information was sought about any changes in number of sexual fantasies and arousal and about other sexual experiences such as orgasmic and coital frequency and enjoyment of sexual activities. Women with dysphoric arousal, a sensation of unpleasant genital engorgement (25), were excluded from the study. The American Foundation for Urologic Disease definition of Female Sexual Function Disorders (26) was used to define SAD, that is, the persistent or recurring inability to attain or maintain sufficient sexual excitement, causing personal distress, which may be expressed as a lack of subjective excitement or genital (lubrication/swelling) or other somatic responses. 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.

• Awareness of sildenafil's potential side effects helps women make informed choices.
• Women should avoid using sildenafil with nitrates to prevent dangerous drops in blood pressure.
• Proper diagnosis of sexual dysfunction can guide appropriate treatment options.
• Scientific research continues to explore safer, women-specific sexual health drugs.
• Sildenafil’s long-term effects on women are not yet fully understood.
• Healthcare providers can help determine if sildenafil is appropriate for individual cases.

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.

Key Words

In male rabbits, diabetes produces penile cavernous trabecular smooth muscle fibrosis based on the degree of hyperglycemia (16). Several pharmacological agents, some with central-acting mechanisms and some with locally acting vascular effects, are therapeutically useful in the treatment of ED (17). Selective phosphodiesterase type 5 (PDE5) inhibitors, taken orally, are effective for men with ED and concomitant type 1 diabetes (18–21). Previous studies suggested that 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 (22, 23). Because subjects affected by chronic illness such as diabetes may suffer from a sexual dysfunction due to neurovascular alterations, research needs to be carried out to find drugs that are effective in treating the pathological effects to improve the quality of sexual life.

Similar content being viewed by others

This double-blind crossover placebo-controlled study was designed to determine whether sildenafil, taken orally, was able to improve sexual genital arousal in type 1 diabetic women with SAD using subjective and objective instruments to measure the efficacy of the drug. This was an independent study performed at the Research Group for Sexology of the Department of Microbiological and Gynaecological Science, School of Medicine, University of Catania, Catania, Italy. The Institutional Review Board of the department approved the study. Thus 36 consecutive premenopausal women aged 27–43 years, with a mean age (±SD) of 34 (±3.6) and a body mass index of 25.3 ± 3.8, affected by type 1 diabetes that was being treated with insulin therapy, and visiting the outpatient Sexology Service for SAD were invited to participate. All the subjects gave their written informed consent before entering the study, which was conducted in accordance with the Helsinki Declaration.

Exploratory Phase 2b RESPOND Study, Completed in 2023

However, the subjects could terminate participation at any time. The study was not advertised, and no remuneration was offered. The sample consisted of volunteers who had had a stable, satisfying heterosexual relationship for at least 6 month and subjectively normal sexual desire toward their partners (see Instruments section). Women were excluded from the study if they had a history of hypertension, coronary artery disease, or thromboembolic disorder; impaired hepatic and renal function and neoplasia; were taking hormone therapy or oral contraceptives; had a history of smoking and alcohol abuse; did not have a sexual partner; were affected by situational sexual dysfunction with their partner; or had a partner with sexual dysfunction. All patients admitted to the screening phase had regular menstrual cycles (mean cycle length 26.7 ± 4.2 days), with ovulation.