- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06370221
The Effect of Psoriatic Arthritis on Female Sexual Dysfunction
The Effect of Psoriatic Arthritis on Female Sexual Dysfunction and Their Relation to Sex Hormones
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Eisa Hegazy, Professor
- Phone Number: +201094337795
- Email: eisa_mohamed4152@med.svu.edu.eg
Study Locations
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Qinā, Egypt
- Qena Hospital
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Contact:
- Eisa Hegazy, Assist.Prof
- Phone Number: 01094337795
- Email: eisa_mohamed4152@med.svu.edu.eg
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Sampling Method
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
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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
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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.
Other Names:
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Group B: Control Group
About 80 healthy control females
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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.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Evaluation of female sexual function
Time Frame: 6 months
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To identify and understand the mechanisms of sexual problems in Psoriatic arthritis Patients in Qena university hospital.
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6 months
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- psoriatic Arthritis
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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