Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment with BP101 | Experimental |
| |
| Treatment with placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BP101 | Drug | Investigational product BP101, nasal spray |
| |
| 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 |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Women aged from 21 to 50 years old
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Daniil G. Nemenov, MD | Ivix LLX | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Алтайский государственный медицинский университет | Barnaul | Russia | ||||
| Kazan State Medical University |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D020018 | Sexual Dysfunctions, Psychological |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo |
| Drug |
Placebo to Investigational product BP101, nasal spray |
|
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) |
| Kazan' |
| Russia |
| Kuban State Medical University | Krasnodar | Russia |
| Central Clinical Hospital of the Russian Academy of Sciences | Moscow | Russia |
| N.A. Alexeev Moscow Psychiatric Clinical Hospital #1 | Moscow | Russia |
| National Medical Research Center of Obstetrics, Gynecology and Perinatology | Moscow | Russia |
| National Medical Research Center of Psychiatry and Addiction named after V.P. Serbsky | Moscow | Russia |
| Clinical Psychiatry Hospital №1 | Nizhny Novgorod | Russia |
| Orenburg Regional Clinical Psychiatric Hospital No. 2 | Orenburg | Russia |
| City psychiatric hospital №7 named after academician I.P. Pavlov | Saint Petersburg | Russia |
| Doctor SAN Ltd. | Saint Petersburg | Russia |
| Leningrad Regional Narcological Dispensary | Saint Petersburg | Russia |
| OrKli Hospital LLC | Saint Petersburg | Russia |
| Research center Eco-Safety LLC | Saint Petersburg | Russia |
| Samara Psychiatric Hospital | Samara | Russia |
| Regional Clinical Psychiatric Hospital of St. Sofia | Saratov | Russia |
| Engels Psycyatric hospital | Saratovskaya | Russia |
| Clinic "Hundred Years" | Tomsk | Russia |
| Bashkir State Medical University | Ufa | Russia |
| Yaroslavl Regional Clinical Psychiatric Hospital | Yaroslavl | Russia |