Evaluation of the Efficacy, Safety and Tolerability of BZ371A in Women with Sexual Arousal Disorder

Inclusion Criteria: * Women between the ages 21 and 60; * Pre-menopausal or post-menopausal women may be included; * May or may not be taking female sex hormones (estrogen with or without progesterone, or their derivatives); * FSAD, defined as the inability, persistent or recurrent, to obtain or maintain until the conclusion of sexual activity an adequate genital response to sexual arousal (lubrication, warmth and enlargement of the clitoris); * Women with FSAD who present marked suffering or interpersonal difficulties; * Stable relationship for more than 6 months, with a sexually active partner; * Ability to read and understand the Informed Consent Form (ICF) and to answer the questionnaires. Exclusion Criteria: * Women who do not agree to use a contraceptive method and who have the capacity to become pregnant during the study; * Women who do not agree to attempt sexual activity at least twice a week while taking the study medication; * History of unresolved sexual trauma or abuse; * Diagnosis of vaginismus, genitopelvic pain/penetration disorder and/or sexual aversion disorder; * Uncontrolled diabetes at screening visit (HbA1C \> 10%); * Prior spinal cord injury, with lower limb paralysis; * History of abdominal or pelvic surgery that may have damaged pelvic nerves, including vulvectomy, colostomy, cytostomy, hysterectomy, or bladder suspension. * Current testosterone use, or long-term testosterone use (such as chip) within the past 6 months; * Presence of menstrual irre…