Study of the Efficacy and Safety of BP101 in Female Patients With Decrease or Loss of Sexual Desire

Study Overview
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Brief Summary
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This is study of the efficacy, safety and pharmacokinetics of BP101 compared to placebo in patients with a decrease or loss of sexual desire.

Official Title
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International, Multicenter, Double-blind, Randomized, Placebo-controlled Phase 2a Study of the Efficacy and Safety of BP101 in Female Patients With Decrease or Loss of Sexual Desire

Conditions
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Hypoactive Sexual Desire Disorder (HSDD)

Intervention / Treatment
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* Drug: BP101
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women aged 21 or older, who have signed informed concent, with a regular menstrual cycle (STRAW stages -5 to -3 (see Annex 7)). The level of follicle-stimulating hormone (FSH) is not more than 25 milli-International unit per ml (mIU/ml) according to the screening values. Decrease or loss of sexual desire (ICD-10 code: F-52.0) corresponding to the hypoactive sexual desire disorder (HSDD) diagnosed according to Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM4), criteria. Current HSDD episode lasting not less than 24 weeks. Patients with secondary female sexual arousal disorder (FSAD) and/or female orgasmic disorder (FOD) will be eligible only if the HSDD developed before the FSAD and/or FOD and the HSDD has a more significant impact on the patient's quality of life. 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. 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. Surgical interventions (other than cosmetic surgeries) on reproductive organs in past medical history (ovariectomy, hysterectomy, obvious scars from childbirth-related perineal stitches, etc). 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.

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment with BP101<br> | Drug: BP101<br> <br> |
| Placebo Comparator: Treatment with placebo<br> | Drug: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Desire domain score in the Female Sexual Function Index | Change in the Desire domain score in the Female Sexual Function Index (FSFI) after 28 days (4 weeks) of treatment compared with the baseline. | 28 days (4 weeks) of treatment | 
| Item 13 score in the Female Sexual Distress Scale-Revised | Change of Item 13 score in the Female Sexual Distress Scale-Revised (FSDS-R) after 28 days (4 weeks) of treatment compared with the baseline. | 28 days (4 weeks) of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Desire domain in the Female Sexual Function Index | Change of the Desire domain in the Female Sexual Function Index (FSFI) after 28 days (4 weeks) and 56 days (8 weeks) of follow-up compared with the baseline. | 28 days (4 weeks) of treatment and 56 days (8 weeks) of follow-up | 
| Item 13 score in the Female Sexual Distress Scale-Revised | Change of Item 13 score in the Female Sexual Distress Scale-Revised (FSDS-R) after 28 days (4 weeks) and 56 days (8 weeks) of follow-up compared with the baseline. | 28 days (4 weeks) of treatment and 56 days (8 weeks) of follow-up | 
| Satisfying sexual events | Change in the number of satisfying sexual events (SSEs) in proportion to the 28 day period after 28 days (4 weeks) of the therapy and after 28 days (4 weeks) and 56 days (8 weeks) of follow-up compared with the baseline. | 28 days (4 weeks) of treatment and 56 days (8 weeks) of follow-up | 
| The total score of the Female Sexual Function Index | Change of the total score of the Female Sexual Function Index (FSFI) after 28 days (4 weeks) of the therapy and after 28 days (4 weeks) and 56 days (8 weeks) of follow-up compared with the baseline. | 28 days (4 weeks) of treatment and 56 days (8 weeks) of follow-up | 
| The total score of the Female Sexual Distress Scale-Revised | Change of total score of the Female Sexual Distress Scale-Revised (FSDS-R) after 28 days (4 weeks) of the therapy and after 28 days (4 weeks) and 56 days (8 weeks) of follow-up compared with the baseline. | 28 days (4 weeks) of treatment and 56 days (8 weeks) of follow-up | 
| The sexual function according to the Female Sexual Function questionnaire | Change of the sexual function according to the Female Sexual Function questionnaire (FSF) after 28 days (4 weeks) of the therapy and after 28 days (4 weeks) and 56 days (8 weeks) of follow-up compared with the baseline. | 28 days (4 weeks) of treatment and 56 days (8 weeks) of follow-up | 
| The patient's assessment of efficacy of the therapy according to the Patient Global Impression of Improvement | The patient's assessment of efficacy of the therapy according to the Patient Global Impression of Improvement (PGI-I) after 28 days (4 weeks) of the therapy and after 28 days (4 weeks) and 56 days (8 weeks) of the follow-up. | 28 days (4 weeks) of treatment and 56 days (8 weeks) of follow-up | 
| Number of adverse events | Frequency of adverse events reporting, including serious adverse events, in treatment groups. | 28 days (4 weeks) of treatment and 56 days (8 weeks) of follow-up |