Efficiency of Tadalafil for Management of Female Sexual Dysfunction

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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Sexual Dysfunction
• Intervention / Treatment: Drug: Tadalafil 5mg; Drug: Placebo

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 Type: Interventional
• Enrollment (Anticipated): 24
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Kasr Elainy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 23 years to 33 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

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

Exclusion Criteria:

• any medical disorder

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: tadalafil group; 5 mg of Tadalafil on daily bases for one month duration	Drug: Tadalafil 5mg; oral tablets for one month duration
Placebo Comparator: placebo group; the patients will receive oral tablets without any active substance for one month	Drug: Placebo; oral tablets for one month duration

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
clitorial Artery Doppler	Pulsatile index	after one month duration of drug use
Clitorial artery doppler	Resistance index	after one month duration of drug use
Clitorial artery doppler	Peak systolic velosity	after one month duration of drug use

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
score of sexual function	arousal orgasm frequency	after on month of the drug use

Collaborators and Investigators

• Sponsor: Kasr El Aini Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): March 10, 2022
• Primary Completion (Anticipated): May 1, 2022
• Study Completion (Anticipated): May 1, 2022

Study Registration Dates

• First Submitted: February 22, 2022
• First Submitted That Met QC Criteria: March 3, 2022
• First Posted (Actual): March 4, 2022

Study Record Updates

• Last Update Posted (Actual): March 4, 2022
• Last Update Submitted That Met QC Criteria: March 3, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: Sexual dysfunction; female genital mutilation; Clitoral artery Doppler
• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Vasodilator Agents; Urological Agents; Enzyme Inhibitors; Phosphodiesterase Inhibitors; Phosphodiesterase 5 Inhibitors; Tadalafil
• Other Study ID Numbers: 22022022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: the exel sheet
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No