BP101 for Adults With Female Sexual Dysfunction

NCT ID: NCT03463707

Last Updated: 2020-02-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 205 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-03-05
• Study Completion Date: 2019-01-23

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.

Conditions

Hypoactive Sexual Desire Disorder; Female Sexual Dysfunction; Sexual Desire Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Treatment with BP101

Group Type: EXPERIMENTAL

BP101

Intervention Type: DRUG

Investigational product BP101, nasal spray

Treatment with placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo to Investigational product BP101, nasal spray

Interventions

BP101

Investigational product BP101, nasal spray

Intervention Type: DRUG

Placebo

Placebo to Investigational product BP101, nasal spray

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Ivix LLX

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Daniil G. Nemenov, MD

Role: STUDY_DIRECTOR

Ivix LLX

Locations

Алтайский государственный медицинский университет

Barnaul, , Russia

Kazan State Medical University

Kazan', , Russia

Kuban State Medical University

Krasnodar, , Russia

Central Clinical Hospital of the Russian Academy of Sciences

Moscow, , Russia

N.A. Alexeev Moscow Psychiatric Clinical Hospital #1

Moscow, , Russia

National Medical Research Center of Obstetrics, Gynecology and Perinatology

Moscow, , Russia

National Medical Research Center of Psychiatry and Addiction named after V.P. Serbsky

Moscow, , Russia

Clinical Psychiatry Hospital №1

Nizhny Novgorod, , Russia

Orenburg Regional Clinical Psychiatric Hospital No. 2

Orenburg, , Russia

City psychiatric hospital №7 named after academician I.P. Pavlov

Saint Petersburg, , Russia

Doctor SAN Ltd.

Saint Petersburg, , Russia

Leningrad Regional Narcological Dispensary

Saint Petersburg, , Russia

OrKli Hospital LLC

Saint Petersburg, , Russia

Research center Eco-Safety LLC

Saint Petersburg, , Russia

Samara Psychiatric Hospital

Samara, , Russia

Regional Clinical Psychiatric Hospital of St. Sofia

Saratov, , Russia

Engels Psycyatric hospital

Saratovskaya, , Russia

Clinic "Hundred Years"

Tomsk, , Russia

Bashkir State Medical University

Ufa, , Russia

Yaroslavl Regional Clinical Psychiatric Hospital

Yaroslavl, , Russia

Countries

Russia

Other Identifiers

BP101-SD02-RUS

Identifier Type: -

Identifier Source: org_study_id