- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05018065
Sexual Functions and Covid-19
August 24, 2021 updated by: Fatma ketenci gencer, Gaziosmanpasa Research and Education Hospital
Evaluation of Women's Sexual Functions After Having Covid-19
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
With identifying a new type of coronavirus, the infection disease known as Coronavirus disease-2019 (Covid-19) is still effective worldwide.
Within the frame of the description that the health is "a complete physical, mental and social welfare," many physical and mental modality may be expected due to the pandemic and the measures against pandemic.
Among them, sexual health is one of the basic indicative factors of human welfare.
There are few data on sexual dysfunctions from the previous clinic pandemic experiences.
From the very early stages of Covid-19 pandemic, health systems and researches focused on mortalities and short-term morbidities.
Although there are similar studies about effects of pandemic on sexual behaviors of general community, there is no comparative study about the effects on sexual functions of women survived from Covid-19 and women having no Covid-19 history, yet.
This study aims to compare women survived from Covid-19 and women having no Covid-19 history and having similar characteristics in terms of sexual dysfunctions.
Study Type
Interventional
Enrollment (Actual)
101
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Istanbul, Turkey
- Saglık Bilimleri University Istanbul Gaziosmanpa Trainig and Research Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
30 years to 45 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- previously diagnosed for mild - medium Covid-19 infection and had ambulatory care
- being sexually active
Exclusion Criteria:
- having psychiatric disease
- having any malignity
- having endometriosis
- having a gynecologic surgery history
- having a previous sexual dysfunction
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Non-Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: 50 women previously diagnosed with mild - medium Covid-19 and had ambulatory care
Women sexual dysfunctions were screened using Female Sexual Functioning Index (FSFI)
|
sexual dysfunction assesment
|
|
Active Comparator: 51 women having no Covid-19 history
Women sexual dysfunctions were screened using Female Sexual Functioning Index (FSFI)
|
sexual dysfunction assesment
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Sexual function assesment of women previously diagnosed with mild - medium Covid-19 and comparision of results with helath women
Time Frame: 6 months
|
Sexual function assesment of women is done by using Female Sexual Functioning Index (FSFI).
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 1, 2020
Primary Completion (Actual)
December 1, 2020
Study Completion (Actual)
December 30, 2020
Study Registration Dates
First Submitted
August 23, 2021
First Submitted That Met QC Criteria
August 23, 2021
First Posted (Actual)
August 24, 2021
Study Record Updates
Last Update Posted (Actual)
August 27, 2021
Last Update Submitted That Met QC Criteria
August 24, 2021
Last Verified
January 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GaziosmanpasaTREHe
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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