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Efficiency of Tadalafil for Management of Female Sexual Dysfunction

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05266651
Recruitment Status : Unknown
Verified March 2022 by Hussein Aly Hussein, Kasr El Aini Hospital.
Recruitment status was:  Not yet recruiting
First Posted : March 4, 2022
Last Update Posted : March 4, 2022
Sponsor:
Information provided by (Responsible Party):
Hussein Aly Hussein, Kasr El Aini Hospital

Study Description
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Brief Summary:
comparative study between tadalafil versus placebo effect for the management of circumsized female

Condition or disease Intervention/treatment Phase
Sexual Dysfunction Drug: Tadalafil 5mg Drug: Placebo Phase 2 Phase 3

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Efficiency of Tadalafil for Management of Female Sexual Dysfunction in Females With Genital Mutilation
Estimated Study Start Date : March 10, 2022
Estimated Primary Completion Date : May 2022
Estimated Study Completion Date : May 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Tadalafil

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. clitorial Artery Doppler [ Time Frame: after one month duration of drug use ]
    Pulsatile index

  2. Clitorial artery doppler [ Time Frame: after one month duration of drug use ]
    Resistance index

  3. Clitorial artery doppler [ Time Frame: after one month duration of drug use ]
    Peak systolic velosity


Secondary Outcome Measures :
  1. score of sexual function [ Time Frame: after on month of the drug use ]
    arousal orgasm frequency


Eligibility Criteria
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Ages Eligible for Study:   25 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • any medical disorder
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05266651


Locations
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Egypt
Kasr Elainy
Cairo, Egypt
Sponsors and Collaborators
Kasr El Aini Hospital
More Information
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Responsible Party: Hussein Aly Hussein, Assistant professor, Kasr El Aini Hospital
ClinicalTrials.gov Identifier: NCT05266651    
Other Study ID Numbers: 22022022
First Posted: March 4, 2022    Key Record Dates
Last Update Posted: March 4, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: the exel sheet
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hussein Aly Hussein, Kasr El Aini Hospital:
female genital mutilation
Sexual dysfunction
Clitoral artery Doppler
Additional relevant MeSH terms:
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Tadalafil
Vasodilator Agents
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
 Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Urological Agents