NCT04816370

Brief Summary

A total of 68 women with pSS and 135 healthy female patients were included in the study. All women in the study and control groups were evaluated gynecologically, and genital findings during the examination and variables related to pSS were recorded. Women's sexual functions were evaluated with the Female Sexual Function Index (FSFI) and quality of life was evaluated using the Health Status Questionnaire-Short Form 36.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
68

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

July 2, 2015

Completed
5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 15, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 25, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 23, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 25, 2021

Completed
Last Updated

March 25, 2021

Status Verified

March 1, 2021

Enrollment Period

5.4 years

First QC Date

March 23, 2021

Last Update Submit

March 24, 2021

Conditions

Primary Sjögren Syndrome

Keywords

primary Sjögren's Syndromevaginal atrophysexual dysfunction

Outcome Measures

Primary Outcomes (1)

  • Sexual Function

    The sexual functions of women participating in the study were evaluated in six subdomains, arousal, desire, lubrication, orgasm, pain, and satisfaction.Higher scores demonstrate preferable sexual function. The total score is obtained by adding the scores of six-subdomains

    1 day

Study Arms (4)

pSS group

EXPERIMENTAL

primary Sjögren's syndrome group

Diagnostic Test: FSFI

Control Group

EXPERIMENTAL

Control group

Diagnostic Test: FSFI

pSS Premenopausal

EXPERIMENTAL

primary Sjögren's syndrome premenopausal patients

Diagnostic Test: FSFI

pSS Postmenopausal

EXPERIMENTAL

primary Sjögren's syndrome postmenopausal patients

Diagnostic Test: FSFI

Interventions

FSFIDIAGNOSTIC_TEST

2 group and 2 subgroup

Control GrouppSS PostmenopausalpSS PremenopausalpSS group

Eligibility Criteria

Age20 Years - 70 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical Diagnosis of pSS healthy females who presented to the gynecology outpatient clinic for reasons other than sexual dysfunction -

You may not qualify if:

  • Pregnancy hepatic, renal, interstitial lung, gynecological oncological diseases, psychiatric disorders communication impairment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara Training and Education Hospital

Ankara, 06230, Turkey (Türkiye)

Location

Related Publications (2)

  • Maddali Bongi S, Del Rosso A, Orlandi M, Matucci-Cerinic M. Gynaecological symptoms and sexual disability in women with primary Sjogren's syndrome and sicca syndrome. Clin Exp Rheumatol. 2013 Sep-Oct;31(5):683-90. Epub 2013 May 27.

    PMID: 23710558RESULT

  • McCoy SS, Sampene E, Baer AN. Association of Sjogren's Syndrome With Reduced Lifetime Sex Hormone Exposure: A Case-Control Study. Arthritis Care Res (Hoboken). 2020 Sep;72(9):1315-1322. doi: 10.1002/acr.24014.

    PMID: 31233285RESULT

MeSH Terms

Conditions

Sexual Dysfunction, Physiological

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Officials

  • Murat Gözüküçük

    Ankara Training and Research Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SCREENING
Intervention Model
CROSSOVER
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 23, 2021

First Posted

March 25, 2021

Study Start

July 2, 2015

Primary Completion

November 15, 2020

Study Completion

January 25, 2021

Last Updated

March 25, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)