NCT05018065

Brief Summary

Sexual health is one the important components of life quality. The aim of this study is to compare sexual dysfunction of women who survived Covid-19 and who didn't undergo Covid-19.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
101

participants targeted

Target at P50-P75 for not_applicable covid19

Timeline
Completed

Started May 2020

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

May 1, 2020

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2020

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

August 23, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 24, 2021

Completed
Last Updated

August 27, 2021

Status Verified

January 1, 2021

Enrollment Period

7 months

First QC Date

August 23, 2021

Last Update Submit

August 24, 2021

Conditions

Covid19Sexual Behavior

Outcome Measures

Primary Outcomes (1)

  • Sexual function assesment of women previously diagnosed with mild - medium Covid-19 and comparision of results with helath women

    Sexual function assesment of women is done by using Female Sexual Functioning Index (FSFI).

    6 months

Study Arms (2)

50 women previously diagnosed with mild - medium Covid-19 and had ambulatory care

ACTIVE COMPARATOR

Women sexual dysfunctions were screened using Female Sexual Functioning Index (FSFI)

Behavioral: Women sexual dysfunctions were screened using Female Sexual Functioning Index (FSFI)

51 women having no Covid-19 history

ACTIVE COMPARATOR

Women sexual dysfunctions were screened using Female Sexual Functioning Index (FSFI)

Behavioral: Women sexual dysfunctions were screened using Female Sexual Functioning Index (FSFI)

Interventions

Women sexual dysfunctions were screened using Female Sexual Functioning Index (FSFI)BEHAVIORAL

sexual dysfunction assesment

50 women previously diagnosed with mild - medium Covid-19 and had ambulatory care51 women having no Covid-19 history

Eligibility Criteria

Age30 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • previously diagnosed for mild - medium Covid-19 infection and had ambulatory care
  • being sexually active

You may not qualify if:

  • having psychiatric disease
  • having any malignity
  • having endometriosis
  • having a gynecologic surgery history
  • having a previous sexual dysfunction

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Saglık Bilimleri University Istanbul Gaziosmanpa Trainig and Research Hospital

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

COVID-19Sexual Behavior

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesBehavior

Study Design

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

Study Record Dates

First Submitted

August 23, 2021

First Posted

August 24, 2021

Study Start

May 1, 2020

Primary Completion

December 1, 2020

Study Completion

December 30, 2020

Last Updated

August 27, 2021

Record last verified: 2021-01

Locations

TU(1)