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Sildenafil improves sexual functioning in premenopausal women with type 1 diabetes who are affected by sexual arousal disorder: a double-blind, crossover, placebo-controlled pilot study

Caruso S, Rugolo S, Agnello C, Intelisano G, Di Mari L, Cianci A

Fertility and sterility, 2006

Abstract

OBJECTIVE: To verify whether sildenafil is effective in type 1 premenopausal women affected by sexual arousal disorder (SAD).

DESIGN: Double-blind, crossover, placebo-controlled study.

SETTING: Gynecological diabetic outpatient clinic and sexual clinic.

PATIENT(S): Thirty-six type 1 premenopausal diabetic women affected by SAD.

INTERVENTION(S): Two 8-week periods of sildenafil 100 mg, washout, and placebo, by two possible sequences.

MAIN OUTCOMES MEASURE(S): Each woman submitted blood samples to measure HbA(1c), and T, free T (FT), and PRL. Efficacy was assessed [1] subjectively by the Personal Experiences Questionnaire based on the 5-point Likert scale, quantifying arousal, desire, orgasm, enjoyment of sexual activities, and frequency of sexual relationships; and [2] objectively by translabial color Doppler ultrasound to measure the resistance index (RI), pulsatility index (PI), peak systolic velocity (PSV), and end diastolic velocity of clitoral arteries.

RESULT(S): Thirty-two women completed the study. The mean HbA(1c) value was 8.0% +/- 1.8%, and plasma concentrations of T, FT, and PRL were normal. Sildenafil seems to improve arousal, orgasm and sexual enjoyment, and dyspareunia in women affected by type 1 diabetes. However, by flowmetric measurements, the mean RI was significantly lower and both the mean PI and PSV of the clitoral arteries were significantly higher compared with baseline and placebo.

CONCLUSION(S): Sildenafil seems to improve subjective sexual aspects…

How strong is the evidence?

Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design.

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