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BP101 for Adults With Female Sexual Dysfunction

Primary Purpose

Hypoactive Sexual Desire Disorder, Female Sexual Dysfunction, Sexual Desire Disorder

Status

Completed

Phase

Phase 3

Locations

Russian Federation

Study Type

Interventional

Intervention

BP101

Placebo

About this trial

This is an interventional treatment trial for Hypoactive Sexual Desire Disorder

Eligibility Criteria

21 Years - 50 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

Алтайский государственный медицинский университет
Kazan State Medical University
Kuban State Medical University
Central Clinical Hospital of the Russian Academy of Sciences
N.A. Alexeev Moscow Psychiatric Clinical Hospital #1
National Medical Research Center of Obstetrics, Gynecology and Perinatology
National Medical Research Center of Psychiatry and Addiction named after V.P. Serbsky
Clinical Psychiatry Hospital №1
Orenburg Regional Clinical Psychiatric Hospital No. 2
City psychiatric hospital №7 named after academician I.P. Pavlov
Doctor SAN Ltd.
Leningrad Regional Narcological Dispensary
OrKli Hospital LLC
Research center Eco-Safety LLC
Samara Psychiatric Hospital
Engels Psycyatric hospital
Regional Clinical Psychiatric Hospital of St. Sofia
Clinic "Hundred Years"
Bashkir State Medical University
Yaroslavl Regional Clinical Psychiatric Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Treatment with BP101

Treatment with placebo

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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.

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).

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.

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.

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.

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.

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.

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.

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).

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.

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.

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.

Number of adverse events

Frequency of adverse events reporting, including serious adverse events, in treatment groups.

Full Information

NCT ID

NCT03463707

First Posted

February 26, 2018

Last Updated

February 10, 2020

Sponsor

Ivix LLX

1. Study Identification

Unique Protocol Identification Number

NCT03463707

Brief Title

BP101 for Adults With Female Sexual Dysfunction

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2020

Overall Recruitment Status

Completed

Study Start Date

March 5, 2018 (Actual)

Primary Completion Date

November 26, 2018 (Actual)

Study Completion Date

January 23, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Ivix LLX

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hypoactive Sexual Desire Disorder, Female Sexual Dysfunction, Sexual Desire Disorder

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

205 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Treatment with BP101

Arm Type

Experimental

Arm Title

Treatment with placebo

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

BP101

Intervention Description

Investigational product BP101, nasal spray

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo to Investigational product BP101, nasal spray

Primary Outcome Measure Information:

Title

Satisfying sexual events

Description

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

Secondary Outcome Measure Information:

Title

Satisfying sexual events

Description

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

Title

Orgasms

Description

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