BP101 for Adults With Female Sexual Dysfunction

Hypoactive Sexual Desire Disorder Clinical Trial

Official title:

Multicenter, Double-blind, Randomized, Placebo-controlled Phase III Confirmatory Study of the Efficacy and Safety of BP101 in Female Patients With Decrease or Loss of Sexual Desire

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03463707
• Other study ID #: BP101-SD02-RUS
• Status: Completed
• Phase: Phase 3
• Start date: March 5, 2018
• Est. completion date: January 23, 2019

Study information

• Verified date: February 2020
• Source: Ivix LLX
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 205
• Est. completion date: January 23, 2019
• Est. primary completion date: November 26, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years to 50 Years

Eligibility

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 depressive disorder is observed in the patient.

• Inflammatory diseases of pelvic organs, infections of the genitourinary system, cervicitis, interstitial cystitis, vulvodynia or severe atrophy of the vaginal epithelium, precluding normal sexual activity.

• Surgical interventions (other than cosmetic surgeries) on reproductive organs in past medical history (ovariectomy, hysterectomy, obvious scars from childbirth-related perineal stitches, etc), resulting in pain/dyspareunia, and/or precluding sexual contacts, and/or requires hormonal replacement treatment, and/or lead to the loss of sensibility while sexual contact.

• Pregnant and nursing women or non-lactating women during the first 12 months after childbirth.

• Consumption of more than 5 portions of alcoholic drinks per week or alcohol addiction, drug addiction or drug abuse in the past. One portion of an alcoholic drink means 360 ml of beer, 120 ml of wine or 30 ml of a strong alcoholic drink.

Related Conditions & MeSH terms

• Disease
• Female Sexual Dysfunction
• Hypoactive Sexual Desire Disorder
• Sexual Desire Disorder
• Sexual Dysfunctions, Psychological

Intervention

Drug:
• BP101
Investigational product BP101, nasal spray
• Placebo
Placebo to Investigational product BP101, nasal spray

Locations

Country	Name	City	State
Russian Federation	????????? ??????????????? ??????????? ???????????	Barnaul
Russian Federation	Kazan State Medical University	Kazan
Russian Federation	Kuban State Medical University	Krasnodar
Russian Federation	Central Clinical Hospital of the Russian Academy of Sciences	Moscow
Russian Federation	N.A. Alexeev Moscow Psychiatric Clinical Hospital #1	Moscow
Russian Federation	National Medical Research Center of Obstetrics, Gynecology and Perinatology	Moscow
Russian Federation	National Medical Research Center of Psychiatry and Addiction named after V.P. Serbsky	Moscow
Russian Federation	Clinical Psychiatry Hospital ?1	Nizhniy Novgorod
Russian Federation	Orenburg Regional Clinical Psychiatric Hospital No. 2	Orenburg
Russian Federation	City psychiatric hospital ?7 named after academician I.P. Pavlov	Saint Petersburg
Russian Federation	Doctor SAN Ltd.	Saint Petersburg
Russian Federation	Leningrad Regional Narcological Dispensary	Saint Petersburg
Russian Federation	OrKli Hospital LLC	Saint Petersburg
Russian Federation	Research center Eco-Safety LLC	Saint Petersburg
Russian Federation	Samara Psychiatric Hospital	Samara
Russian Federation	Regional Clinical Psychiatric Hospital of St. Sofia	Saratov
Russian Federation	Engels Psycyatric hospital	Saratovskaya
Russian Federation	Clinic "Hundred Years"	Tomsk
Russian Federation	Bashkir State Medical University	Ufa
Russian Federation	Yaroslavl Regional Clinical Psychiatric Hospital	Yaroslavl'

Sponsors (1)

Lead Sponsor	Collaborator
Ivix LLX

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	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.	Baseline and 4 weeks of treatment, 4 and 8 weeks of follow-up
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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)