MedTrace Logo

BP101 for Adults With Female Sexual Dysfunction

NCT03463707 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 205

Last updated 2020-02-11

No results posted yet for this study

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

Interventions

DRUG

BP101

Investigational product BP101, nasal spray

DRUG

Placebo

Placebo to Investigational product BP101, nasal spray

Sponsors & Collaborators

  • Ivix LLX

    lead INDUSTRY

Principal Investigators

  • Daniil G. Nemenov, MD · Ivix LLX

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-03-05
Primary Completion
2018-11-26
Completion
2019-01-23

Countries

  • Russia

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03463707 on ClinicalTrials.gov