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 untilthe 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 thequestionnaires.

Exclusion Criteria:

• Women who do not agree to use a contraceptive method and who have the capacity tobecome pregnant during the study;

• Women who do not agree to attempt sexual activity at least twice a week while takingthe study medication;

• History of unresolved sexual trauma or abuse;

• Diagnosis of vaginismus, genitopelvic pain/penetration disorder and/or sexualaversion 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 thepast 6 months;

• Presence of menstrual irregularity or endocrinopathies that significantly alter themenstrual cycle, preventing Cytocam analyses from taking place at the same time;

• Patients with current depression, characterized by the use or need for use ofpsychotropic drugs, including bupropion, lithium, or neuroleptics;

• Presence of genital lesions that impair analysis of local adverse effects on thegenitalia;

• Presence of diseases that cause excessive vaginal discharge, such as recurrenturinary tract infection, vaginal infection and pelvic inflammatory disease.

• Abnormal Papanicolaou test within the past 3 years;

• History of gynecological cancer (history of uterine dysplasia can be included,provided it has been properly treated for at least 6 months);

• History of pelvic irradiation;

• Use of topical medications in the genital region that may interfere with PSIassessment as well as their absorption or drug interaction, including vaginalestrogens, lubricants, spermicides, creams or gels, vaginal douches;

• History of symptomatic hypotension, or diseases that increase the risk ofsymptomatic hypotension, such as patient with heart disease (including history ofangina and/or heart failure) and nephropathies;

• Current use of nitrates, such as propatylnitrate (Sustrate®), isosorbide (Monocordil®, Cincordil®, Isordil®), nitroglycerin (Nitradisc®, Nitroderm TTS®,Nitronal®, Tridil®) and sosorbitol dinitrate (Isocord®)

• ECG findings that are clinically symptomatic, or that, in the Investigator'sjudgment, are considered significant and pose a risk to the research volunteer'sparticipation;

• Findings on laboratory tests that, in the Investigator's judgment, are consideredsignificant and offer risk to the research volunteer's participation or may hinderthe study analyses;

• TSH outside normal limits for age (participants with hypothyroidism on stable doseof medication, over 3 months, may be included);

• BP outside safe limits: SBP below 90 mmHg or above 170 mmHg; or DBP below 50 mmHg orabove 100 mmHg, except for situations such as "white coat" syndrome

• Severe hypertension, considered as use of three or more antihypertensives;

• Diseases that can cause clitoral priapism, such as sickle cell anemia, multiplemyeloma or leukemia;

• History of clitoral priapism;

• Current relevant diarrhea, defined as duration over four weeks, association withabdominal pain or malabsorptive syndrome, or presence of mucus, pus, or blood in thestool;

• Pregnant or lactating;

• Current use of nitric oxide donors, guanylate cyclase stimulators (e.g. Riociguat),or 5- phosphodiesterase inhibitors (Sildenafil, Tadalafil, etc.);

• Any disease or condition or physical finding that the Investigator considerssignificant and that increases the risk of the research participant's participationor may interfere with the results, including serious debilitating diseases, presenceof cancer, serious mental illness, persistent abuse of medication.