BP101 for Adults With Female Sexual Dysfunction (NCT03463707) | Clinical Trial Compass
CompletedPhase 3
BP101 for Adults With Female Sexual Dysfunction
Russia205 participantsStarted 2018-03-05
Plain-language summary
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.
Who can participate
Age range21 Years – 50 Years
SexFEMALE
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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 depressiv…