NCT06370221

Brief Summary

Psoriasis is one of the most common immunemediated chronic inflammatory skin disorders.

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
180

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

April 13, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 17, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2024

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2024

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2024

Completed
Last Updated

April 17, 2024

Status Verified

April 1, 2024

Enrollment Period

7 months

First QC Date

April 13, 2024

Last Update Submit

April 13, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Evaluation of female sexual function

    To identify and understand the mechanisms of sexual problems in Psoriatic arthritis Patients in Qena university hospital.

    6 months

Study Arms (2)

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

Behavioral: The effect of psoriatic Arthritis

Group B: Control Group

About 80 healthy control females

Behavioral: The effect of psoriatic Arthritis

Interventions

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.

Also known as: Female Sexual dysfunction
Group A: Cases GroupGroup B: Control Group

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Qena Hospital

Qina, Egypt

Location

MeSH Terms

Conditions

Arthritis, Psoriatic

Condition Hierarchy (Ancestors)

SpondylarthropathiesSpondylarthritisSpondylitisSpinal DiseasesBone DiseasesMusculoskeletal DiseasesArthritisJoint DiseasesPsoriasisSkin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue Diseases

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 13, 2024

First Posted

April 17, 2024

Study Start

June 1, 2024

Primary Completion

December 20, 2024

Study Completion

December 30, 2024

Last Updated

April 17, 2024

Record last verified: 2024-04

Locations