NCT05266651

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
24

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Mar 2022

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 22, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 4, 2022

Completed
6 days until next milestone

Study Start

First participant enrolled

March 10, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2022

Completed
Last Updated

March 4, 2022

Status Verified

March 1, 2022

Enrollment Period

2 months

First QC Date

February 22, 2022

Last Update Submit

March 3, 2022

Conditions

Sexual Dysfunction

Keywords

female genital mutilationSexual dysfunctionClitoral artery Doppler

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (1)

  • score of sexual function

    after on month of the drug use

Study Arms (2)

tadalafil group

ACTIVE COMPARATOR

5 mg of Tadalafil on daily bases for one month duration

Drug: Tadalafil 5mg

placebo group

PLACEBO COMPARATOR

the patients will receive oral tablets without any active substance for one month

Drug: Placebo

Interventions

Tadalafil 5mgDRUG

oral tablets for one month duration

tadalafil group
PlaceboDRUG

oral tablets for one month duration

placebo group

Eligibility Criteria

Age25 Years - 35 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • any medical disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kasr Elainy

Cairo, Egypt

Location

MeSH Terms

Conditions

Sexual Dysfunction, Physiological

Interventions

Tadalafil

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Intervention Hierarchy (Ancestors)

CarbolinesPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsIndole AlkaloidsIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds, 3-Ring

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

February 22, 2022

First Posted

March 4, 2022

Study Start

March 10, 2022

Primary Completion

May 1, 2022

Study Completion

May 1, 2022

Last Updated

March 4, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will share

the exel sheet

Shared Documents
STUDY PROTOCOL, SAP

Locations

EG(1)