NCT03463707

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
205

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Mar 2018

Shorter than P25 for phase_3

Geographic Reach
1 country

20 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 26, 2018

Completed
7 days until next milestone

Study Start

First participant enrolled

March 5, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 13, 2018

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 26, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 23, 2019

Completed
Last Updated

February 11, 2020

Status Verified

February 1, 2020

Enrollment Period

9 months

First QC Date

February 26, 2018

Last Update Submit

February 10, 2020

Conditions

Hypoactive Sexual Desire DisorderFemale Sexual DysfunctionSexual Desire Disorder

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (14)

  • Satisfying sexual events

    Baseline and 4 and 8 weeks of follow-up

  • Orgasms

    Baseline and 4 weeks of treatment, 4 and 8 weeks of follow-up

  • Female Sexual Function Index total score

    Baseline and 4 weeks of treatment, 4 and 8 weeks of follow-up

  • Female Sexual Function Index Desire domain score

    Baseline and 4 weeks of treatment, 4 and 8 weeks of follow-up

  • Female Sexual Function Index Arousal domain score

    Baseline and 4 weeks of treatment, 4 and 8 weeks of follow-up

  • +9 more secondary outcomes

Study Arms (2)

Treatment with BP101

EXPERIMENTAL
Drug: BP101

Treatment with placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

BP101DRUG

Investigational product BP101, nasal spray

Treatment with BP101
PlaceboDRUG

Placebo to Investigational product BP101, nasal spray

Treatment with placebo

Eligibility Criteria

Age21 Years - 50 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsWomen aged from 21 to 50 years old
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (20)

Алтайский государственный медицинский университет

Barnaul, Russia

Location

Kazan State Medical University

Kazan', Russia

Location

Kuban State Medical University

Krasnodar, Russia

Location

Central Clinical Hospital of the Russian Academy of Sciences

Moscow, Russia

Location

N.A. Alexeev Moscow Psychiatric Clinical Hospital #1

Moscow, Russia

Location

National Medical Research Center of Obstetrics, Gynecology and Perinatology

Moscow, Russia

Location

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

Moscow, Russia

Location

Clinical Psychiatry Hospital №1

Nizhny Novgorod, Russia

Location

Orenburg Regional Clinical Psychiatric Hospital No. 2

Orenburg, Russia

Location

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

Saint Petersburg, Russia

Location

Doctor SAN Ltd.

Saint Petersburg, Russia

Location

Leningrad Regional Narcological Dispensary

Saint Petersburg, Russia

Location

OrKli Hospital LLC

Saint Petersburg, Russia

Location

Research center Eco-Safety LLC

Saint Petersburg, Russia

Location

Samara Psychiatric Hospital

Samara, Russia

Location

Regional Clinical Psychiatric Hospital of St. Sofia

Saratov, Russia

Location

Engels Psycyatric hospital

Saratovskaya, Russia

Location

Clinic "Hundred Years"

Tomsk, Russia

Location

Bashkir State Medical University

Ufa, Russia

Location

Yaroslavl Regional Clinical Psychiatric Hospital

Yaroslavl, Russia

Location

MeSH Terms

Conditions

Sexual Dysfunctions, Psychological

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

  • Daniil G. Nemenov, MD

    Ivix LLX

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 26, 2018

First Posted

March 13, 2018

Study Start

March 5, 2018

Primary Completion

November 26, 2018

Study Completion

January 23, 2019

Last Updated

February 11, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

Locations

RU(20)