Sexual DysfunctionPhase 2/3NCT05266651
Efficiency of Tadalafil for Management of Female Sexual Dysfunction
A Phase 2/3 study testing Tadalafil 5mg in people with Sexual Dysfunction, run by Kasr El Aini Hospital at 1 site in Egypt.
Trial summary
comparative study between tadalafil versus placebo effect for the management of circumsized female Read more about this study
- Who is it for?
- Ages 25 to 35 years, women only
- Conditions the study is for
- Sexual Dysfunction
- What is being tested?
- Tadalafil 5mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Mar 2022to May 2022
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- female with history of female genital mutilation female with history of sexual dysfunction
Who cannot join
- any medical disorder
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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
- Conditions
- Sexual Dysfunction
- Being tested
- Tadalafil 5mg, Placebo
- Keywords
- female genital mutilation, Sexual dysfunction, Clitoral artery Doppler
- Medical subject headings
- Sexual Dysfunction, Physiological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tadalafil 5mgDrug
oral tablets for one month duration
PlaceboDrug
oral tablets for one month duration
| Study group | Role | What they receive |
|---|---|---|
| tadalafil group | Active comparator | 5 mg of Tadalafil on daily bases for one month duration Receives: Drug: Tadalafil 5mg |
| placebo group | Placebo comparator | the patients will receive oral tablets without any active substance for one month Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
clitorial Artery Doppler
Pulsatile index
Measured: after one month duration of drug use
Clitorial artery doppler
Resistance index
Measured: after one month duration of drug use
Clitorial artery doppler
Peak systolic velosity
Measured: after one month duration of drug use
Secondary outcomes (1)
score of sexual function
arousal orgasm frequency
Measured: after on month of the drug use
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2022
- Study start10 Mar 2022 (estimated)
- Primary completionMay 2022 (estimated)
- Study completionMay 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sexual DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kasr El Aini Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hussein Aly Hussein, Kasr El Aini Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05266651
- Sponsor's protocol ID
- 22022022
- Status last verified
- Mar 2022
- First submitted
- 22 Feb 2022
- Last updated
- 4 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: the exel sheet
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficiency of Tadalafil for Management of Female Sexual Dysfunction in Females With Genital Mutilation
- ClinicalTrials.gov ID
- NCT05266651
- Acronym / sponsor ID
- 22022022
- Conditions
- Sexual Dysfunction
- Keywords
- female genital mutilation, Sexual dysfunction, Clitoral artery Doppler
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Kasr El Aini HospitalUniversity, hospital or other
- Study start
- 10 Mar 2022 (estimated)
- Primary completion
- May 2022 (estimated)
- Study completion
- May 2022 (estimated)
- First posted
- 4 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| tadalafil group | Active comparator | Drug: Tadalafil 5mg5 mg of Tadalafil on daily bases for one month duration |
| placebo group | Placebo comparator | Drug: Placebothe patients will receive oral tablets without any active substance for one month |
Who may qualify
- Ages
- 25 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- female with history of female genital mutilation female with history of sexual dysfunction
Key exclusion criteria (1 listed)
- any medical disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tadalafil 5mgoral tablets for one month duration | Drug | tadalafil group |
| Placebooral tablets for one month duration | Drug | placebo group |
Primary outcome
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
1 secondary outcome
score of sexual function
Time frame: after on month of the drug use
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2022.
- Individual participant dataSharing planned: Yes. the exel sheet
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Tadalafil 5mg in people with Sexual Dysfunction, run by Kasr El Aini Hospital at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
clitorial Artery Doppler (time frame: after one month duration of drug use). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2022.