Clinical trial NCT03463707 (phase 3, status: completed)
Conditions: hypoactive sexual desire disorder, female sexual dysfunction, sexual desire disorder
ICD codes: F52.0
Drugs: bp101, placebo
SMILES: CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O
Eligibility criteria:

        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.