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Efficiency of Tadalafil for Management of Female Sexual Dysfunction

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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

Tracking Information
First Submitted Date  ICMJE February 22, 2022
First Posted Date  ICMJE March 4, 2022
Last Update Posted Date March 4, 2022
Estimated Study Start Date  ICMJE March 10, 2022
Estimated Primary Completion Date May 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 3, 2022)
  • clitorial Artery Doppler [ Time Frame: after one month duration of drug use ]
    Pulsatile index
  • Clitorial artery doppler [ Time Frame: after one month duration of drug use ]
    Resistance index
  • Clitorial artery doppler [ Time Frame: after one month duration of drug use ]
    Peak systolic velosity
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: March 3, 2022)		 score of sexual function [ Time Frame: after on month of the drug use ]
arousal orgasm frequency
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficiency of Tadalafil for Management of Female Sexual Dysfunction
Official Title  ICMJE Efficiency of Tadalafil for Management of Female Sexual Dysfunction in Females With Genital Mutilation
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Sexual Dysfunction
Intervention  ICMJE
  • Drug: Tadalafil 5mg
    oral tablets for one month duration
  • Drug: Placebo
    oral tablets for one month duration
Study Arms  ICMJE
  • Active Comparator: tadalafil group
    5 mg of Tadalafil on daily bases for one month duration
    Intervention: Drug: Tadalafil 5mg
  • Placebo Comparator: placebo group
    the patients will receive oral tablets without any active substance for one month
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: March 3, 2022)		 24
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 2022
Estimated Primary Completion Date May 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

  • any medical disorder
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 25 Years to 35 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Egypt
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05266651
Other Study ID Numbers  ICMJE 22022022
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: the exel sheet
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Current Responsible Party Hussein Aly Hussein, Kasr El Aini Hospital
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Kasr El Aini Hospital
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Kasr El Aini Hospital
Verification Date March 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP