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Evaluation of the Efficacy, Safety and Tolerability of BZ371A in Women with Sexual Arousal Disorder

NCT06116045 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2024-10-22

No results posted yet for this study

Summary

To determine the efficacy in increasing sexual arousal, safety and tolerability of BZ371A in gel form applied to women with sexual arousal disorder.

Conditions

  • Female Sexual Arousal Disorder
  • Female Sexual Dysfunction

Interventions

DRUG

BZ371A 7.5 mg (1.5 ml)

7.5 mg gel

DRUG

BZ371A 5.0 mg (1.0 ml)

5.0 mg gel

DRUG

BZ371A 2.5 mg (0.5 ml)

2.5 mg gel

DRUG

Placebo (1.5 ml)

BZ371A-matched placebo

DRUG

Placebo (1.0 ml)

BZ371A-matched placebo

DRUG

Placebo (0.5 ml)

BZ371A-matched placebo

Sponsors & Collaborators

  • Biozeus Biopharmaceutical S.A.

    lead INDUSTRY

Principal Investigators

  • Marco Aurélio Oliveira, MD · Centro de Pesquisa Clínica Multiusuário (CePeM)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2024-10-01
Primary Completion
2025-02-01
Completion
2025-03-31

Countries

  • Brazil

Study Locations

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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 NCT06116045 on ClinicalTrials.gov