Drug Treatment Options For Female Sexual Dysfunction

Sexual dysfunction (SD) is a broad term for a variety of symptoms and syndromes that affect sexual function and satisfaction. In general, sexual function is multifactorial, with biological, psychological and social factors all playing an integral role. Nevertheless, there is a growing interest in understanding the biological components of sexual dysfunction, which has led to the emergence of medical and pharmacological therapies. Female sexual dysfunction (FSD) is an umbrella term that covers multiple aspects of sexual desire, arousal, orgasm, and/or pain. Persistent, recurrent problems with arousal, sexual desire, orgasm, or pain that are distressing to the patient or strain the relationship with the partner are called sexual dysfunctions. Female sexual dysfunction can occur at any stage of life and can significantly reduce the quality of life for many women. With up to 45% of women experiencing sexual health problems, most commonly 39% with low libido and 12% with sex-related pain, the true incidence of SD may be underestimated. Although the sexual function is a complex biopsychosocial construct, there are many pharmacological treatment options designed to address the changing vaginal hormonal environment in postmenopausal individuals and to modulate central nervous system arousal and inhibition in patients with hypoactive sexual desire disorder. Over the past decade, there has been an increase in the number and type of pharmacotherapeutic options for dysfunction primarily associated with menopause and hypoactive sexual desire disorder. Centrally acting therapies such as topical estrogen and testosterone replacement medications in postmenopausal individuals and flibanserin, bremelanotide, and testosterone in premenopausal individuals designated female at birth are safe and can be used to increase libido and sexual satisfaction.

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Table 1 - Summary of pharmacological treatment options for sexual dysfunction in premenopausal and postmenopausal individuals

Genitourinary syndrome of menopause

Genitourinary syndrome of menopause (GSM) refers to the symptoms associated with a low estrogenic state. Although most often associated with menopause, hypoestrogenic states can also be seen with surgical menopause, hypothalamic amenorrhea, lactation, a history of long-term oral contraceptive use, hormone therapy for breast cancer or sexual irritability, a history of pelvic radiation therapy, or having received chemotherapy. An estimated 27-84% of postmenopausal individuals experience GSM, which can present with a range of symptoms, including vaginal dryness, burning or irritation, difficulty having intercourse, decreased libido and sexual arousal, and urinary symptoms. GSM also has a significant impact on quality of life, with 75% of individuals reporting that their symptoms negatively impacted their lives. While vasodilatory symptoms (VMS) tend to improve over time, GSM is often progressive and requires ongoing management.

Non-hormonal therapies

Moisturizers and Lubricants

Lubricants are usually used during intercourse, while vaginal moisturizers have a longer duration of action and can be used regularly. Vaginal moisturizers act as emollients that are absorbed into the skin, thereby rehydrating the lining of the vagina. The effects of vaginal moisturizers usually last 2-3 days. In addition to increasing vaginal hydration, some products (such as Replens) have been found to lower the pH to return it to premenopausal acidity. Replens may be used in place of hormone therapy or as an adjunct to vaginal estrogen, often on alternate days. In a randomized trial of 172 postmenopausal individuals with vaginal dryness randomized to receive either a non-hormonal vaginal moisturizer or vaginal estriol (0.1%) cream, non-hormonal moisturizers were found to be non-inferior to vaginal estriol symptoms in improving symptoms in women with mild to moderate vaginal dryness. Although an earlier systematic evaluation found the use of vaginal estrogens to be superior to moisturizers for patients with more than one symptom, this study adds support for the use of vaginal moisturizers for mild to moderate GSM. Both hyaluronic acid and polycarbophil-based polymers are used as active ingredients in vaginal moisturizers. In a randomized trial comparing hyaluronic acid and polycarbophil emollients in 53 people, symptoms improved in both groups, with no significant difference between the two.

Vaginal Estrogens

Vaginal estrogens continue to be the primary treatment for GSM. Formulations include 17-β-estradiol cream or ring, combined with equine estrogen cream and estradiol vaginal tablets or gel capsules. Low doses of vaginal estrogens are sufficient to treat GSM symptoms, and numerous studies have shown no change in systemic estrogen levels above normal postmenopausal levels. a 2016 Cochrane review found no difference in the improvement of GSM symptoms with vaginal estrogen preparations, although they concluded that the quality of evidence for the superiority of vaginal estrogens over placebo for the treatment of vulvovaginal atrophy was low. In a recent systematic evaluation of the efficacy and safety of vaginal estrogens, vaginal estrogens were superior to placebo for all objective and subjective endpoints of GSM. Vaginal estrogens are typically administered once daily for two weeks and then 2-3 times per week. The estradiol ring is replaced every 3 months, but may be challenging to maintain in women with pelvic organ prolapse. Although it may take several months to achieve maximum benefit, improvement in difficulty with intercourse may be seen even within the first 2 weeks of treatment.

Vaginal estrogen is generally considered safe, even for individuals with a history of breast cancer. The American College of Obstetrics and Gynecology consensus statement on vaginal estrogen in patients with breast cancer, including those currently taking tamoxifen or aromatase inhibitors, states that vaginal estrogen may be used if non-hormonal vaginal moisturizers are inadequate and the patient makes shared decisions with their provider. Although vaginal estrogen use is associated with endometrial thickening, there is no clear association with endometrial cancer. Finally, while systemic estrogen use was associated with dementia, there was no association between vaginal estrogen and dementia in population-based studies.

Vaginal Androgen Therapy

Vaginal Prasterone (DHEA)

Androgens are important for sexual health, and testosterone is associated with libido, sexual arousal, genital blood flow, vaginal lengthening, and lubrication in AFAB individuals. Testosterone is produced by the adrenal glands and ovaries, and as individuals enter menopause, their testosterone levels are approximately 50% of premenopausal levels. In addition, androgen receptors are present in female genital tissue. Dehydroepiandrosterone (DHEA) is produced physiologically by the adrenal glands and subsequently metabolized to androgens (androstenedione and testosterone), which are then further aromatized to estrogens (estrone, estradiol), . Vaginally administered DHEA 6.5 mg (prandione, FDA approved in 2016) is locally converted to testosterone, dihydrotestosterone (DHT), and estradiol in vaginal tissues. Similar to vaginal estrogens, systemic levels of estrogen and androgens do not increase with vaginal DHEA and it appears to be safe for breast cancer patients. Vaginal DHEA has also been found to improve objective and subjective symptoms and sexual function in GSM].A 2018 systematic review of three randomized trials found significant improvement in vaginal dryness with DHEA compared to placebo, but no difference in the incidence of difficulty with intercourse. Vaginal DHEA is an alternative therapy for 12-15% of individuals whose symptoms persist despite estrogen use].

Vaginal Testosterone

Although not FDA-approved in the United States, vaginal testosterone therapy (0.1%) can be used in combination with GSM. In a systematic evaluation, vaginal testosterone had similar effects on sexual function as vaginal estrogen. In two small trials of vaginal testosterone in breast cancer patients, vaginal testosterone improved dyspareunia and vaginal dryness. Due to the limited data available, NAMS does not recommend the use of vaginal testosterone for GSM.

Systemic Hormone Therapy

Systemic Estrogen/Progestin

Individuals with both GSM and VMS may choose systemic hormone replacement therapy, i.e. estrogen alone (after hysterectomy) or combined estrogen/progesterone. In a systematic review of three studies comparing systemic hormone therapy with vaginal estrogen, there were no differences in subjective (urinary urgency, vaginal dryness, painful intercourse) or objective (vaginal maturation, pH) markers of GSM, but the incidence of adverse events was higher in the systemic estrogen group. However, it should be noted that systemic therapy may not adequately address GSM symptoms. In such cases, a combination of vaginal and systemic estrogens is recommended. If systemic estrogen therapy is used, the lowest dose required for symptom relief should be given. In addition, since VMS symptoms tend to improve over time, women can stop using systemic hormones and transition to vaginal estrogens with far fewer side effects.