MenopausemenopauseNCT05312099
The Effect of Menopause on Sexual Life and Depression: a Case-control Study.
An observational study of Menopause and Depression, run by Hitit University at 1 site in Turkey (Türkiye).
Trial summary
work completed but not yet published Read more about this study
- Who is it for?
- Ages 45 to 65 years, women only
- Conditions the study is for
- Menopause, Depression, Sexual Dysfunction
- How many people
- 3 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 14 Jan 2019to 16 Feb 2021
- How long will I take part?
- 3 Months
- Phase
- Observational
- 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 45 to 65 years
- Women only
- Adult, Older adult
Study population: Çorum Hitit University Erol Olçok Training and Research Hospital Obstetrics and Gynecology Policlinic was composed of 200 married women between the ages of 45-65, 113 of them in the postmenopausal period and 87 of them did not go through menopause.
Who may be able to join
- Case group: Women between the ages of 45-65, who are in the postmenopausal period, who are literate, who do not have communication difficulties / mental disabilities, and who volunteer to participate in the study were included.
- Control Group: Women between the ages of 45-55, who were not menopausal, who were literate, who had no communication difficulties / mental disabilities and who volunteered to participate in the study were included.
Who cannot join
- For case group: Women with premature menopause (before the age of 40), chronic systemic disease (diabetes, heart disease, hypertension, thyroid, rheumatic disease, psychiatric disease history) and using psychiatric drugs were not included in the study.
- For control group: Women under the age of 45, over the age of 55 with chronic systemic diseases (diabetes, heart disease, hypertension, thyroid, rheumatic disease, psychiatric disease history) and using psychiatric drugs were not included in the study.
Trial locations and contacts
1 site in 1 country.
About this study
work completed but not yet published
Read the detailed description
work completed but not yet published
- Conditions
- Menopause, Depression, Sexual Dysfunction
- Being tested
- Case control
- Medical subject headings
- Depression, Sexual Dysfunction, Physiological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Case controlOther
Case control study
| Study group | Role | What they receive |
|---|---|---|
| Case group | Women who have entered early menopause (before the age of 40), have chronic systemic diseases (diabetes, heart disease, hypertension, thyroid, rheumatic disease, psychiatric disease history), and use psychiatric drugs were not included in the study. Receives: Other: Case control | |
| Control group | Women under the age of 45, over the age of 55 with chronic systemic diseases (diabetes, heart disease, hypertension, thyroid, rheumatic disease, psychiatric disease history) and using psychiatric drugs were not included in the study. Receives: Other: Case control |
What is being measured
The primary outcome is the main question the study is designed to answer.
The effect of menopause on sexual life and depression: a case-control study.
Data completed in April 2019
Measured: 14.01.2019-16.02.2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2022
- Study start14 Jan 2019
- Primary completion17 Apr 2019
- Study completion16 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MenopauseStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 3 participants (actual)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Hitit University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatma Yildirim, Hitit University
- Investigators
- Fatma Yıldırım, Principal investigator, Fatma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05312099
- Sponsor's protocol ID
- 2018-20
- Acronym
- menopause
- Status last verified
- Mar 2022
- First submitted
- 3 Dec 2021
- Last updated
- 5 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Menopause on Sexual Life and Depression: a Case-control Study.
- ClinicalTrials.gov ID
- NCT05312099
- Acronym / sponsor ID
- menopause / 2018-20
- Conditions
- Menopause, Depression, Sexual Dysfunction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Hitit UniversityUniversity, hospital or other
- Study start
- 14 Jan 2019 (actual)
- Primary completion
- 17 Apr 2019 (actual)
- Study completion
- 16 Feb 2021 (actual)
- First posted
- 5 Apr 2022 (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.
work completed but not yet published
Detailed description
work completed but not yet published
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 3 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case group | – | Other: Case controlWomen who have entered early menopause (before the age of 40), have chronic systemic diseases (diabetes, heart disease, hypertension, thyroid, rheumatic disease, psychiatric disease history), and use psychiatric drugs were not included in the study. |
| Control group | – | Other: Case controlWomen under the age of 45, over the age of 55 with chronic systemic diseases (diabetes, heart disease, hypertension, thyroid, rheumatic disease, psychiatric disease history) and using psychiatric drugs were not included in the study. |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- Çorum Hitit University Erol Olçok Training and Research Hospital Obstetrics and Gynecology Policlinic was composed of 200 married women between the ages of 45-65, 113 of them in the postmenopausal period and 87 of them did not go through menopause.
Key inclusion criteria (2 listed)
- Case group: Women between the ages of 45-65, who are in the postmenopausal period, who are literate, who do not have communication difficulties / mental disabilities, and who volunteer to participate in the study were included.
- Control Group: Women between the ages of 45-55, who were not menopausal, who were literate, who had no communication difficulties / mental disabilities and who volunteered to participate in the study were included.
Key exclusion criteria (2 listed)
- For case group: Women with premature menopause (before the age of 40), chronic systemic disease (diabetes, heart disease, hypertension, thyroid, rheumatic disease, psychiatric disease history) and using psychiatric drugs were not included in the study.
- For control group: Women under the age of 45, over the age of 55 with chronic systemic diseases (diabetes, heart disease, hypertension, thyroid, rheumatic disease, psychiatric disease history) and using psychiatric drugs were not included in the study.
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 |
|---|---|---|
| Case controlCase control study | Other | Case group, Control group |
Primary outcome
The effect of menopause on sexual life and depression: a case-control study.
Time frame: 14.01.2019-16.02.2021
Data completed in April 2019
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 5 Apr 2022.
- Individual participant dataSharing planned: No
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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.
Fatma Yıldırım principal investigator
Fatma
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Menopause and Depression, run by Hitit University 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 2 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 5 Apr 2022. 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?
The effect of menopause on sexual life and depression: a case-control study. (time frame: 14.01.2019-16.02.2021). 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 5 Apr 2022.