Efficiency of Tadalafil for Management of Female Sexual Dysfunction

Phase 2

• Conditions: Sexual Dysfunction
• Interventions: Drug: Tadalafil 5mg; Drug: Placebo

• Registration Number: NCT05266651
• Lead Sponsor: Kasr El Aini Hospital

Brief Summary

comparative study between tadalafil versus placebo effect for the management of circumsized female

Detailed Description

the group of patient will be randomly divided into 2 groups, half of the patients will receive tadalafil and the other half will receive placebo

Study Timeline

• Study First Submitted: 2022-02-22
• Status Verified: 2022-03
• Study First Submitted QC: 2022-03-03
• Last Update Submitted: 2022-03-03
• Study First Posted: 2022-03-04
• Last Update Posted: 2022-03-04
• Study Start: 2022-03-10
• Primary Completion: 2022-05
• Study Completion: 2022-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 24

Inclusion Criteria

• female with history of female genital mutilation female with history of sexual dysfunction

Exclusion Criteria

• any medical disorder

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
tadalafil group	Tadalafil 5mg	5 mg of Tadalafil on daily bases for one month duration
placebo group	Placebo	the patients will receive oral tablets without any active substance for one month

Primary Outcome Measures

Name	Time	Method
clitorial Artery Doppler	after one month duration of drug use	Pulsatile index
Clitorial artery doppler	after one month duration of drug use	Peak systolic velosity

Secondary Outcome Measures

Name	Time	Method
score of sexual function	after on month of the drug use	arousal orgasm frequency

Trial Locations

Locations (1)

Kasr Elainy; 🇪🇬 Cairo, Egypt