ClinicalTrials.gg
Status unknownNCT05266651Updated Mar 4, 2022

Efficiency of Tadalafil for Management of Female Sexual Dysfunction

A Phase 2/3 interventional study of Tadalafil 5mg and Placebo in Sexual Dysfunction, sponsored by Kasr El Aini Hospital. Status unknown at 1 site in Egypt. Open to female participants aged 25 Years to 35 Years. Per ClinicalTrials.gov, last updated 2022-03-04.

Sponsored by Kasr El Aini Hospital · Phase 2/3, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Mar 2022), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Phase 2/3
Study type
Interventional
Enrollment
24
Allocation
Randomized
Ages
25 Years to 35 Years
Sex
Female
01

Study summary

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

Read the 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

02

Conditions studied

  • Sexual Dysfunction

Keywords

  • female genital mutilation
  • Sexual dysfunction
  • Clitoral artery Doppler
03

In context

Sexual Dysfunction, Physiological

125 studies on the registry are indexed under Sexual Dysfunction, Physiological; 45 are open to participants now.

This study's planned enrollment of 24 is below the median of 60 across 88 interventional studies indexed under Sexual Dysfunction, Physiological.

Browse Sexual Dysfunction, Physiological studies →

Lead sponsor

Kasr El Aini Hospital is the lead sponsor of 283 studies on the registry; 33 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
25 Years to 35 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • any medical disorder
05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
24 participants (estimated)

Study arms

  • Active comparator
    tadalafil group

    5 mg of Tadalafil on daily bases for one month duration

    Drug: Tadalafil 5mg

  • Placebo comparator
    placebo group

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

    Drug: Placebo

Interventions

  • oral tablets for one month duration

  • DrugPlacebo

    oral tablets for one month duration

06

What researchers measure

Primary outcomes

  1. clitorial Artery Doppler

    Pulsatile index

    Time frame: after one month duration of drug use

  2. Clitorial artery doppler

    Resistance index

    Time frame: after one month duration of drug use

  3. Clitorial artery doppler

    Peak systolic velosity

    Time frame: after one month duration of drug use

Secondary outcomes

  1. score of sexual function

    arousal orgasm frequency

    Time frame: after on month of the drug use

07

Study locations

1 site
  • Kasr Elainy
    Cairo, Egypt
08

References and documents

Individual participant data

Plan to share: Yes — the exel sheet

Supporting information: Study protocol, Statistical analysis plan

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 4, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05266651
Responsible party
Hussein Aly Hussein (Assistant professor, Kasr El Aini Hospital) — Principal investigator
First posted
Mar 4, 2022
Start date
Mar 10, 2022 (estimated)
Primary completion
May 2022 (estimated)
Completion
May 2022 (estimated)
Last update
Mar 4, 2022

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Tadalafil

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