Ladygra for the Treatment of Female Sexual Arousal Disorder

As per the American Foundation of Urological Diseases, female sexual arousal disorder (FSAD) is defined as “a persistent or recurring inability to attain or maintain sufficient sexual excitement that causes personal suffering”. This may be experienced as an absence of personal excitement, genital lubrication/ swelling, genital sensation or other somatic responses. FSAD may occur self-sufficiently of or concomitantly with other separate female sexual disorders, like hypoactive sexual desire disorder (HSDD), female orgasmic disorder and/or dyspareunia. Though psychosocial factors evidently underwrite to the disorder, medical and physiological factors, with reduced vaginal/clitoral blood flow, changed hormonal environment, previous pelvic surgery (like hysterectomy), vaginal injury from childbearing or use of some medications, may be the main basis for the disorder. Augmented clitoral and vaginal vasocongestion during sexual arousal is supposed to be arbitrated by the nitric oxide– cyclic guanosine monophosphate pathway. Results of nitric oxide synthase in human clitoral tissue and phosphodiesterase 5 (PDE5), the enzyme accountable for cGMP breakdown, in human clitoral and vaginal tissue back this concept. Sildenafil citrate, which is popular among men is also a popular choice among females for the treatment of sexual arousal disorder in females. When intended to be used by women, it is famous by its brand name Ladygra which is also known as Femalegra.

Ladygra is a potent and selective inhibitor of PDE5, causes relaxation of female clitoral and vaginal smooth muscle and inhibits PDE5 in clitoral and vaginal smooth muscle. Improved genital blood flow and vaginal and clitoral distension in women with FSAD have been recognized with sildenafil. Together these findings suggest that sildenafil may be efficacious for treating FSAD of physiological origin. Estrogen and testosterone promote the expression of nitric oxide synthase in human and animal genital tissue. Thus, physiological levels of testosterone and estradiol may augment the response to PDE5 inhibitors in women with FSAD.

The clinical evidence

Aims and objectives of the study

The efficacy and safety of sildenafil (Ladygra) in postmenopausal and hysterectomy undergone women with FSAD who have free testosterone (≥0.9 pg/ml) and estradiol (≥40 pg/ml) which normal values for premenopausal women was evaluated.

The main objective of the study was to evaluate the efficacy and safety of sildenafil citrate (Ladygra) in spontaneously or surgically postmenopausal women having female sexual arousal disorder (FSAD).

Method

A 12-week, double-blind, placebo controlled study was conducted for the evaluation of Ladygra 100mg was done in 202 postmenopausal women with FSAD having the aforementioned estradiol and free testosterone concentrations, and/or were receiving estrogen and/or androgen replacement therapy.

Primary end points

• Questions from the Female Intervention Efficacy Index (FIEI)

Secondary end points

• The Sexual Function Questionnaire

• Sexual activity event log questions

Results

Significant improvements in the second and fourth questions of FIEI were observed with Ladygra vs. placebo. For women having FSAD without concomitant hypoactive sexual desire disorder (HSDD) statistically significant improvement in 5 of 6 FIEI items compared with placebo (p <0.02). For women with concomitant HSDD, there were no significant improvements noted. Adverse events reported were mild to moderate with headache, flushing, rhinitis, nausea and visual symptoms reported most frequently.

Conclusion

Sildenafil ( Ladygra 100mg ) was effective and well tolerated in postmenopausal women with FSAD without associated HSDD or influential emotional, relationship or historical abuse issues. All patients had estradiol and free testosterone concentrations up to the levels which are seen in postmenopausal women normally or were receiving estrogen and/or androgen replacement therapy.