BP101 for Adults With Female Sexual Dysfunction

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Hypoactive Sexual Desire Disorder, Female Sexual Dysfunction, Sexual Desire Disorder

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 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.

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 50 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>* Investigational product BP101, nasal spray<br>|
| Placebo Comparator: Treatment with placebo<br> | Drug: Placebo<br>* Placebo to Investigational product BP101, nasal spray<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Satisfying sexual events | Change in the number of satisfying sexual events (SSEs), standardized to the 28-day period, after 4 weeks of treatment, compared with the baseline. | Baseline and 4 weeks of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Satisfying sexual events | Change in the number of satisfying sexual events (SSEs), standardized to the 28-day period, after 4 and 8 weeks of follow-up, compared with the baseline. | Baseline and 4 and 8 weeks of follow-up | 
| Orgasms | Change in the number of orgasms, standardized to the 28-day period, after 4 weeks of therapy and after 4 and 8 weeks of follow-up, compared with the baseline. | Baseline and 4 weeks of treatment, 4 and 8 weeks of follow-up | 
| Female Sexual Function Index total score | Change in the Female Sexual Function Index (FSFI) total score after 4 weeks of therapy and after 4 and 8 weeks of follow-up, compared with the baseline. FSFI total score ranges from 2.0 to 36.0, where higher score represents better sexual function. FSFI total score is a sum of FSFI individual domains scores (individual domains are: Desire, Arousal, Lubrication, Orgasm, Satisfaction, and Pain). | Baseline and 4 weeks of treatment, 4 and 8 weeks of follow-up | 
| Female Sexual Function Index Desire domain score | Change in the Female Sexual Function Index (FSFI) Desire domain score after 4 weeks of therapy and after 4 and 8 weeks of follow-up, compared with the baseline. FSFI Desire domain score ranges from 1.2 to 6.0, where higher score represents better sexual desire. | Baseline and 4 weeks of treatment, 4 and 8 weeks of follow-up | 
| Female Sexual Function Index Arousal domain score | Change in the Female Sexual Function Index (FSFI) Arousal domain score after 4 weeks of therapy and after 4 and 8 weeks of follow-up, compared with the baseline. FSFI Arousal domain score ranges from 0 to 6.0, where higher score represents better sexual arousal. | Baseline and 4 weeks of treatment, 4 and 8 weeks of follow-up | 
| Female Sexual Function Index Lubrication domain score | Change in the Female Sexual Function Index (FSFI) Lubrication domain score after 4 weeks of therapy and after 4 and 8 weeks of follow-up, compared with the baseline. FSFI Lubrication domain score ranges from 0 to 6.0, where higher score represents better vaginal lubrication. | Baseline and 4 weeks of treatment, 4 and 8 weeks of follow-up | 
| Female Sexual Function Index Orgasm domain score | Change in the Female Sexual Function Index (FSFI) Orgasm domain score after 4 weeks of therapy and after 4 and 8 weeks of follow-up, compared with the baseline. FSFI Orgasm domain score ranges from 0 to 6.0, where higher score represents better orgasm sensation. | Baseline and 4 weeks of treatment, 4 and 8 weeks of follow-up | 
| Female Sexual Function Index Satisfaction domain score | Change in the Female Sexual Function Index (FSFI) Satisfaction domain score after 4 weeks of therapy and after 4 and 8 weeks of follow-up, compared with the baseline. FSFI Satisfaction domain score ranges from 0.8 to 6.0, where higher score represents better sexual satisfaction. | Baseline and 4 weeks of treatment, 4 and 8 weeks of follow-up | 
| Female Sexual Function Index Pain domain score | Change in the Female Sexual Function Index (FSFI) Pain domain score after 4 weeks of therapy and after 4 and 8 weeks of follow-up, compared with the baseline. FSFI Pain domain score ranges from 0 to 6.0, where higher score represents lower pain sensation during sexual intercourse. | Baseline and 4 weeks of treatment, 4 and 8 weeks of follow-up | 
| Female Sexual Distress Scale-Revised Total score | Change in the Female Sexual Distress Scale-Revised (FSDS-R) total score after 4 weeks of therapy and after 4 and 8 weeks of follow-up, compared with the baseline. FSDS-R total score ranges from 0 to 52, where higher score represents higher level of distress related to sexual activities. A score of ≥11 discriminates between women with female sexual disfunction (score of ≥11) and no female sexual disfunction (score of <11). | Baseline and 4 weeks of treatment, 4 and 8 weeks of follow-up | 
| Female Sexual Distress Scale-Revised Item 13 score | Change in the Female Sexual Distress Scale-Revised (FSDS-R) Item 13 score after 4 weeks of therapy and after 4 and 8 weeks of follow-up, compared with the baseline. FSDS-R Item 13 score ranges from 0 to 4, where higher score represents higher level of bother by low sexual desire. | Baseline and 4 weeks of treatment, 4 and 8 weeks of follow-up | 
| Sexual function according to the Female Sexual Function questionnaire | Change in the Female Sexual Function questionnaire (FSF) score after 4 weeks of therapy and after 4 and 8 weeks of follow-up, compared with the baseline. FSF score ranges from 0 to 36, where higher score represents better sexual function. | Baseline and 4 weeks of treatment, 4 and 8 weeks of follow-up | 
| 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 4 weeks of therapy and after 4 and 8 weeks of follow-up, compared with the baseline. | Baseline and 4 weeks of treatment, 4 and 8 weeks of follow-up | 
| Number of adverse events | Frequency of adverse events reporting, including serious adverse events, in treatment groups. | During 12 weeks after start of treatment (4 weeks of treatment and 8 weeks of follow-up) |