A Phase 3 interventional study of BP101 and Placebo in Hypoactive Sexual Desire Disorder, Female Sexual Dysfunction and Sexual Desire Disorder, sponsored by Ivix LLX. Completed at 20 sites in Russian Federation. Open to female participants aged 21 Years to 50 Years. Per ClinicalTrials.gov, last updated 2020-02-11.
Sponsored by Ivix LLX · Phase 3, Interventional, and Treatment
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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.
138 studies on the registry are indexed under Sexual Dysfunctions, Psychological; 10 are open to participants now.
This study's enrollment of 205 is above the median of 100 across 114 interventional studies indexed under Sexual Dysfunctions, Psychological.
Browse Sexual Dysfunctions, Psychological studies →Ivix LLX is the lead sponsor of 3 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: BP101
Drug: Placebo
Investigational product BP101, nasal spray
Placebo to Investigational product BP101, nasal spray
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.
Time frame: Baseline and 4 weeks of treatment
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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: During 12 weeks after start of treatment (4 weeks of treatment and 8 weeks of follow-up)
Plan to share: No
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Ran from Mar 2018 to primary completion in Nov 2018, 8 months.
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This study is completed, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: BP101
Sexual Dysfunctions, Psychological →