This is study of the efficacy, safety and pharmacokinetics of BP101 compared to placebo in patients with a decrease or loss of sexual desire.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
119
V.M. Bekhterev Republic Clinical Psychiatric Hospital
Kazan', Russia
"People's Friendship University of Russia"
Moscow, Russia
Mental Health Research Center
Moscow, Russia
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.
Time frame: 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.
Time frame: 28 days (4 weeks) of treatment
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
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N.A. Alexeev Moscow Psychiatric Clinical Hospital #1
Moscow, Russia
Clinical Psychiatry Hospital №1
Nizhny Novgorod, Russia
Orenburg Regional Clinical Psychiatric Hospital #1
Orenburg, Russia
OrKli Hospital LLC
Saint Petersburg, Russia
Regional Clinical Psychiatric Hospital of St. Sofia
Saratov, Russia
Engels Psycyatric hospital
Saratov Oblast, Russia
Clinic "Hundred Years"
Tomsk, Russia
...and 2 more locations
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 28 days (4 weeks) of treatment and 56 days (8 weeks) of follow-up