Psoriatic ArthritisNCT06370221
The Effect of Psoriatic Arthritis on Female Sexual Dysfunction
An observational study of Psoriatic Arthritis, run by Egymedicalpedia at 1 site in Egypt.
Trial summary
Psoriasis is one of the most common immunemediated chronic inflammatory skin disorders. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Psoriatic Arthritis
- What is being tested?
- The effect of psoriatic Arthritis
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 180 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2024to 30 Dec 2024
- Phase
- Observational
- 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 20 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: The female sexual function index (FSFI) is a self-reported questionnaire that has been validated in Arabic, and is used to measure a woman's sexual function over the course of the past four weeks. A reliable and accurate way to assess female sexual function is the FSFI. The six domains of sexual function-desire, arousal, lubrication, orgasm, satisfaction, and pain-are assessed by the 19 questions in this questionnaire. The response is scored between 0 and 5 on a 5-point Likert scale. Disease Activity in Psoriatic Arthritis (DAPSA) Helps measure disease activity in psoriatic arthritis based on joint symptoms, CRP and pain evaluation
Who may be able to join
- The study will focuses on the relationship between the FSD and PsA;
- The healthy controls will derive from a population within the same geographic area and ethnic background as PsA;
- Used the same questionnaires/instruments of FSFI to diagnose FSD
Who cannot join
- pregnancy,
- breastfeeding
- being sexually inactive
- having a partner with sexual dysfunction,
- refusing to participate, or
- being unable to read
- Females with any sexual transmitted disease
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Qena Hospital
Qina
Eisa Hegazy, Assist.Prof, 01094337795, eisa_mohamed4152@med.svu.edu.eg
About this study
Official title: The Effect of Psoriatic Arthritis on Female Sexual Dysfunction and Their Relation to Sex Hormones
Psoriasis is one of the most common immunemediated chronic inflammatory skin disorders.
Read the detailed description
Psoriasis is one of the most common immunemediated chronic inflammatory skin disorders.
Beside genetic factors, several environmental factors such as injuries, infections, stress, drugs, and immune defect take part in autoimmune pathogenesis of the disease. In addition, it has been reported that some hormones may also have a role in the pathogenesis of psoriasis, due to their effects on keratinocytes proliferation.
Studies revealed that sex hormones manifest a variety of biological and immunological effects in the skin which modulate the natural course of psoriasis.
Approximately 20-30% of patients with psoriasis may also have psoriatic arthritis, which often causes significant musculoskeletal pain that significantly impairs quality of life (QoL).
Although sexual dysfunction is a common complaint, affecting 30 to 70% of psoriasis patients, few studies have analyzed the impact of psoriasis and psoriatic arthritis on quality of sexual life.
- Conditions
- Psoriatic Arthritis
- Being tested
- The effect of psoriatic Arthritis
- Medical subject headings
- Arthritis, Psoriatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The effect of psoriatic ArthritisBehavioural
Also called Female Sexual dysfunction
to assess the frequency rates of sexual problems and associated factors in a cohort of married females with Psoriatic arthritis, and to investigate the correlation between sex hormones profile ( estrogen and progesterone level) and female sexual function in Psoriatic arthritis patients.
| Study group | Role | What they receive |
|---|---|---|
| Group A: Cases Group | About 100 patient females suffering from Psoriatic arthritis and to investigate the correlation between sex hormones profile ( estrogen and progesterone level) and female sexual function in Psoriatic arthritis patients Receives: Behavioral: The effect of psoriatic Arthritis | |
| Group B: Control Group | About 80 healthy control females Receives: Behavioral: The effect of psoriatic Arthritis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of female sexual function
To identify and understand the mechanisms of sexual problems in Psoriatic arthritis Patients in Qena university hospital.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2024
- Study start1 Jun 2024 (estimated)
- Primary completion20 Dec 2024 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psoriatic ArthritisStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Egymedicalpedia
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06370221
- Sponsor's protocol ID
- psoriatic Arthritis
- Status last verified
- Apr 2024
- First submitted
- 13 Apr 2024
- Last updated
- 17 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Psoriatic Arthritis on Female Sexual Dysfunction and Their Relation to Sex Hormones
- ClinicalTrials.gov ID
- NCT06370221
- Acronym / sponsor ID
- psoriatic Arthritis
- Conditions
- Psoriatic Arthritis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- EgymedicalpediaIndustry (pharma, biotech, devices)
- Study start
- 1 Jun 2024 (estimated)
- Primary completion
- 20 Dec 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 17 Apr 2024 (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.
Psoriasis is one of the most common immunemediated chronic inflammatory skin disorders.
Detailed description
Psoriasis is one of the most common immunemediated chronic inflammatory skin disorders.
Beside genetic factors, several environmental factors such as injuries, infections, stress, drugs, and immune defect take part in autoimmune pathogenesis of the disease. In addition, it has been reported that some hormones may also have a role in the pathogenesis of psoriasis, due to their effects on keratinocytes proliferation.
Studies revealed that sex hormones manifest a variety of biological and immunological effects in the skin which modulate the natural course of psoriasis.
Approximately 20-30% of patients with psoriasis may also have psoriatic arthritis, which often causes significant musculoskeletal pain that significantly impairs quality of life (QoL).
Although sexual dysfunction is a common complaint, affecting 30 to 70% of psoriasis patients, few studies have analyzed the impact of psoriasis and psoriatic arthritis on quality of sexual life.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A: Cases Group | – | Behavioral: The effect of psoriatic ArthritisAbout 100 patient females suffering from Psoriatic arthritis and to investigate the correlation between sex hormones profile ( estrogen and progesterone level) and female sexual function in Psoriatic arthritis patients |
| Group B: Control Group | – | Behavioral: The effect of psoriatic ArthritisAbout 80 healthy control females |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- The female sexual function index (FSFI) is a self-reported questionnaire that has been validated in Arabic, and is used to measure a woman's sexual function over the course of the past four weeks. A reliable and accurate way to assess female sexual function is the FSFI. The six domains of sexual function-desire, arousal, lubrication, orgasm, satisfaction, and pain-are assessed by the 19 questions in this questionnaire. The response is scored between 0 and 5 on a 5-point Likert scale. Disease Activity in Psoriatic Arthritis (DAPSA) Helps measure disease activity in psoriatic arthritis based on joint symptoms, CRP and pain evaluation
Key inclusion criteria (3 listed)
- The study will focuses on the relationship between the FSD and PsA;
- The healthy controls will derive from a population within the same geographic area and ethnic background as PsA;
- Used the same questionnaires/instruments of FSFI to diagnose FSD
Key exclusion criteria (7 listed)
- pregnancy,
- breastfeeding
- being sexually inactive
- having a partner with sexual dysfunction,
- refusing to participate, or
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 |
|---|---|---|
| The effect of psoriatic ArthritisAlso: Female Sexual dysfunctionto assess the frequency rates of sexual problems and associated factors in a cohort of married females with Psoriatic arthritis, and to investigate the correlation between sex hormones profile ( estrogen and progesterone level) and female sexual function in Psoriatic arthritis patients. | Behavioural | Group A: Cases Group, Group B: Control Group |
Primary outcome
Evaluation of female sexual function
Time frame: 6 months
To identify and understand the mechanisms of sexual problems in Psoriatic arthritis Patients in Qena university hospital.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2024.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Psoriatic Arthritis, run by Egymedicalpedia 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 3 inclusion and 7 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 17 Apr 2024. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Contact Eisa Hegazy, Professor (+201094337795, eisa_mohamed4152@med.svu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of female sexual function (time frame: 6 months). 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 17 Apr 2024.