Actively Recruiting

Phase 2
Age: 21Years - 60Years
FEMALE
NCT06116045

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

Led by Biozeus Biopharmaceutical S.A. · Updated on 2024-10-22

30

Participants Needed

1

Research Sites

25 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

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

Who Can Participate

Age: 21Years - 60Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Women between the ages 21 and 60
  • Pre-menopausal or post-menopausal women may participate
  • May be taking female sex hormones or not
  • Diagnosed with Female Sexual Arousal Disorder characterized by inability to maintain adequate genital response during sexual activity
  • Experiencing marked distress or relationship difficulties due to FSAD
  • In a stable relationship for more than 6 months with a sexually active partner
  • Able to read and understand the informed consent and complete questionnaires
Not Eligible

You will not qualify if you...

  • Women unwilling to use contraception if able to become pregnant during the study
  • Women unwilling to attempt sexual activity at least twice a week during the study
  • History of unresolved sexual trauma or abuse
  • Diagnosed with vaginismus, genitopelvic pain/penetration disorder, or sexual aversion disorder
  • Uncontrolled diabetes with HbA1C above 10%
  • Prior spinal cord injury causing lower limb paralysis
  • History of pelvic or abdominal surgery that may damage pelvic nerves
  • Current or recent (within 6 months) testosterone use
  • Menstrual irregularities or endocrine disorders affecting menstrual cycle
  • Current depression requiring psychotropic medication
  • Genital lesions that affect local assessments
  • Diseases causing excessive vaginal discharge such as infections or pelvic inflammatory disease
  • Abnormal Pap test within past 3 years
  • History of gynecological cancer or pelvic irradiation
  • Use of topical genital medications that interfere with assessments
  • History of symptomatic hypotension or diseases increasing hypotension risk
  • Current use of nitrates or related heart medications
  • Clinically significant ECG or lab abnormalities
  • Thyroid hormone levels outside normal range unless stable hypothyroidism
  • Blood pressure outside safe limits
  • Severe hypertension requiring three or more medications
  • Diseases causing clitoral priapism or history of priapism
  • Chronic diarrhea or stool abnormalities
  • Pregnant or lactating women
  • Use of nitric oxide donors, guanylate cyclase stimulators, or PDE5 inhibitors
  • Any other significant disease or condition increasing risk or interfering with study results

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Centro de Pesquisa Clínica Multiusuário (CePeM)

Rio de Janeiro, Rio de Janeiro, Brazil, 20551030

Actively Recruiting

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Research Team

C

Camilla Trindade, PhD

CONTACT

G

Gabriela Westerlund, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

TREATMENT

Number of Arms

6

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