BP101 for Adults With Female Sexual Dysfunction

Multicenter, Double-blind, Randomized, Placebo-controlled Phase III Confirmatory Study of the Efficacy and Safety of BP101 in Female Patients With Decrease or Loss of Sexual Desire

This study is to confirm efficacy and safety of study drug BP101 in female patients with with decrease or loss of sexual desire, which is equal to acquired generalized hypoactive sexual desire disorder (HSDD). Patients will be randomized in 1:1 ratio to either BP101 or placebo arms.

Inclusion Criteria:

• Women aged from 21 to 50 years old, who have signed informed concent, with a regular menstrual cycle (STRAW stages -5 to -3).
• Decrease or loss of sexual desire (ICD-10 code: F-52.0) corresponding to the diagnosis of acquired generalized hypoactive sexual desire disorder (HSDD) according to Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM4), criteria.
• Current HSDD episode lasting not less than 24 weeks.
• Not less than 15 scores according to the FSDS-R (Distress) Total Score.
• Stable monogamous relationship with one sexually active male sexual partner lasting at least a year. The partner is physically available not less than 50% of time during a month.
• Consent to attempt to have a sexual intercourse at least twice a month, if she has a desire.
• Consent to complete a diary every day during the screening period and assessment of the baseline state (in this period diary records must cover ≥80% days), during the therapy and subsequent follow-up.
• Consent to use adequate methods of contraception throughout the study.

Exclusion Criteria:

• Any prohibited treatments.
• Other mental disorders or psychiatric diseases.
• Diagnosed Decrease or loss of sexual desire (HSDD) is situational (reactive) or lifelong.
• Score ≥ 20 according to the Beck Depression Inventory during the screening. Patients with 16 to 19 scores according to Beck's inventory may be included in the study unless, in the investigator's opinion, an actual depressive disorder is observed in the patient.
• Inflammatory diseases of pelvic organs, infections of the genitourinary system, cervicitis, interstitial cystitis, vulvodynia or severe atrophy of the vaginal epithelium, precluding normal sexual activity.
• Surgical interventions (other than cosmetic surgeries) on reproductive organs in past medical history (ovariectomy, hysterectomy, obvious scars from childbirth-related perineal stitches, etc), resulting in pain/dyspareunia, and/or precluding sexual contacts, and/or requires hormonal replacement treatment, and/or lead to the loss of sensibility while sexual contact.
• Pregnant and nursing women or non-lactating women during the first 12 months after childbirth.
• Consumption of more than 5 portions of alcoholic drinks per week or alcohol addiction, drug addiction or drug abuse in the past. One portion of an alcoholic drink means 360 ml of beer, 120 ml of wine or 30 ml of a strong alcoholic drink.