Covid19NCT05018065
Sexual Functions and Covid-19
A study testing Women sexual dysfunctions were screened using Female Sexual Functioning Index (FSFI) in people with Covid19 and Sexual Behavior, run by Gaziosmanpasa Research and Education Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Covid19, Sexual Behavior
- What is being tested?
- Women sexual dysfunctions were screened using Female Sexual Functioning Index (FSFI)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2020to 30 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- previously diagnosed for mild - medium Covid-19 infection and had ambulatory care
- being sexually active
Who cannot join
- having psychiatric disease
- having any malignity
- having endometriosis
- having a gynecologic surgery history
- having a previous sexual dysfunction
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Saglık Bilimleri University Istanbul Gaziosmanpa Trainig and Research Hospital
Istanbul
About this study
Official title: 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.
Read the 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.
- Conditions
- Covid19, Sexual Behavior
- Being tested
- Women sexual dysfunctions were screened using Female Sexual Functioning Index (FSFI)
- Medical subject headings
- COVID-19, Sexual Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Women sexual dysfunctions were screened using Female Sexual Functioning Index (FSFI)Behavioural
sexual dysfunction assesment
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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) Receives: Behavioral: Women sexual dysfunctions were screened using Female Sexual Functioning Index (FSFI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2021
- Study start1 May 2020
- Primary completion1 Dec 2020
- Study completion30 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gaziosmanpasa Research and Education Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Fatma ketenci gencer, Gaziosmanpasa Research and Education Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05018065
- Sponsor's protocol ID
- GaziosmanpasaTREHe
- Status last verified
- Jan 2021
- First submitted
- 23 Aug 2021
- Last updated
- 27 Aug 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Women's Sexual Functions After Having Covid-19
- ClinicalTrials.gov ID
- NCT05018065
- Acronym / sponsor ID
- GaziosmanpasaTREHe
- Conditions
- Covid19, Sexual Behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Gaziosmanpasa Research and Education HospitalOther government
- Study start
- 1 May 2020 (actual)
- Primary completion
- 1 Dec 2020 (actual)
- Study completion
- 30 Dec 2020 (actual)
- First posted
- 24 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 50 women previously diagnosed with mild - medium Covid-19 and had ambulatory care | Active comparator | Behavioral: Women sexual dysfunctions were screened using Female Sexual Functioning Index (FSFI)Women sexual dysfunctions were screened using Female Sexual Functioning Index (FSFI) |
| 51 women having no Covid-19 history | Active comparator | Behavioral: Women sexual dysfunctions were screened using Female Sexual Functioning Index (FSFI)Women sexual dysfunctions were screened using Female Sexual Functioning Index (FSFI) |
Who may qualify
- Ages
- 30 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- previously diagnosed for mild - medium Covid-19 infection and had ambulatory care
- being sexually active
Key exclusion criteria (5 listed)
- having psychiatric disease
- having any malignity
- having endometriosis
- having a gynecologic surgery history
- having a previous sexual dysfunction
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Women sexual dysfunctions were screened using Female Sexual Functioning Index (FSFI)sexual dysfunction assesment | Behavioural | 50 women previously diagnosed with mild - medium Covid-19 and had ambulatory care, 51 women having no Covid-19 history |
Primary outcome
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Women sexual dysfunctions were screened using Female Sexual Functioning Index (FSFI) in people with Covid19 and Sexual Behavior, run by Gaziosmanpasa Research and Education Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sexual function assesment of women previously diagnosed with mild - medium Covid-19 and comparision of results with helath women (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2021.