Study of the Efficacy and Safety of BP101 in Female Patients With Decrease or Loss of Sexual Desire (NCT03080298) | Clinical Trial Compass
CompletedPhase 2
Study of the Efficacy and Safety of BP101 in Female Patients With Decrease or Loss of Sexual Desire
Russia119 participantsStarted 2016-03-14
Plain-language summary
This is study of the efficacy, safety and pharmacokinetics of BP101 compared to placebo in patients with a decrease or loss of sexual desire.
Who can participate
Age range21 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 treat…
What they're measuring
1
Desire domain score in the Female Sexual Function Index
Timeframe: 28 days (4 weeks) of treatment
2
Item 13 score in the Female Sexual Distress Scale-Revised