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NCT05266651 Clinical Trial

Efficiency of Tadalafil for Management of Female Sexual Dysfunction

Sexual Dysfunction Clinical Trial

Official title:
Efficiency of Tadalafil for Management of Female Sexual Dysfunction in Females With Genital Mutilation

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT05266651
Other study ID # 22022022
Secondary ID
Status Not yet recruiting
Phase Phase 2/Phase 3
First received
Last updated
Start date March 10, 2022
Est. completion date May 2022

Study information
Verified date March 2022
Source Kasr El Aini Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 24
Est. completion date May 2022
Est. primary completion date May 2022
Accepts healthy volunteers No
Gender Female
Age group 25 Years to 35 Years
Eligibility Inclusion Criteria: - female with history of female genital mutilation female with history of sexual dysfunction Exclusion Criteria: - any medical disorder

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Tadalafil 5mg
oral tablets for one month duration
• Placebo
oral tablets for one month duration

Locations
Country Name City State
Egypt Kasr Elainy Cairo

Sponsors (1)
Lead Sponsor Collaborator
Kasr El Aini Hospital

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary clitorial Artery Doppler Pulsatile index after one month duration of drug use
Primary Clitorial artery doppler Resistance index after one month duration of drug use
Primary Clitorial artery doppler Peak systolic velosity after one month duration of drug use
Secondary score of sexual function arousal orgasm frequency after on month of the drug use
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