Marriage, Life EventNCT01420731
Back Pain and Male Sexual Disfunction
An observational study of Marriage, Life Event, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
Trial summary
Back pain is a common hormonal disorder in men that may affect the phases of male sexual function. The investigators investigated sexual function in male patients with back pain. Read more about this study
- Who is it for?
- Ages 20 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Marriage, Life Event
- How many people
- 54 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Sep 2011to Dec 2011
- 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 20 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Study population: 20-45 years old,male patients with active sexual life
Who may be able to join
- Male patient with back pain
- 20 - 45 years old
- Active sexual life
Who cannot join
- Younger than 20, older than 45 years old
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bezmialem Vakif University
Istanbul, 34093
Gokcen Basaranoglu, MD, 90 532 89 98 71, gbasaranoglu@hotmail.com
Gokcen Basranoglu, MD
About this study
Official title: Phase 4 Study Back Pain and Male Sexual Disfunction
Back pain is a common hormonal disorder in men that may affect the phases of male sexual function. The investigators investigated sexual function in male patients with back pain.
A total of 54 men with back pain and 27 age matched voluntary healthy men who served as the as control group were evaluated with a detailed medical and sexual history, including a international erectile function index (IEFI) questionnaire and the Beck Depression Inventory. Serum prolactin, dehydroepiandrosterone sulfate, free testosterone, androstenedione, 17alpha-hydroxyprogesterone, estradiol, free thyroxin and thyrotropin were measured. These variables were compared statistically between the 2 groups.
Read the detailed description
A total of 54 men with back pain and 27 age matched voluntary healthy men who served as the as control group were evaluated with a detailed medical and sexual history, including a international erectile function index (IEFI) questionnaire and the Beck Depression Inventory. Serum prolactin, dehydroepiandrosterone sulfate, free testosterone, androstenedione, 17alpha-hydroxyprogesterone, estradiol, free thyroxin and thyrotropin were measured. These variables were compared statistically between the 2 groups.
- Conditions
- Marriage, Life Event
- Keywords
- sexual life, back pain
- Medical subject headings
- Back Pain
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2011 (estimated)
- Study startSep 2011
- Primary completionDec 2011 (estimated)
- Study completionDec 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Marriage, Life EventStudies of the same condition, open and under way.
- More trials run by Bezmialem Vakif UniversityThe sponsor's other registered studies.
- 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
- Time perspective
- Prospective
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bezmialem Vakif University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, gokcen basaranoglu, Bezmialem Vakif University
- Investigators
- Gökçen Başaranoğlu, MD, Principal investigator, Beazialem Vakıf University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01420731
- Sponsor's protocol ID
- gbms1
- Status last verified
- Aug 2011
- First submitted
- 19 Aug 2011
- Last updated
- 22 Aug 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 4 Study Back Pain and Male Sexual Disfunction
- ClinicalTrials.gov ID
- NCT01420731
- Acronym / sponsor ID
- gbms1
- Conditions
- Marriage, Life Event
- Keywords
- sexual life, back pain
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Bezmialem Vakif UniversityUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- Dec 2011 (estimated)
- Study completion
- Dec 2011 (estimated)
- First posted
- 22 Aug 2011 (estimated)
- 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.
Back pain is a common hormonal disorder in men that may affect the phases of male sexual function. The investigators investigated sexual function in male patients with back pain.
A total of 54 men with back pain and 27 age matched voluntary healthy men who served as the as control group were evaluated with a detailed medical and sexual history, including a international erectile function index (IEFI) questionnaire and the Beck Depression Inventory. Serum prolactin, dehydroepiandrosterone sulfate, free testosterone, androstenedione, 17alpha-hydroxyprogesterone, estradiol, free thyroxin and thyrotropin were measured. These variables were compared statistically between the 2 groups.
Detailed description
A total of 54 men with back pain and 27 age matched voluntary healthy men who served as the as control group were evaluated with a detailed medical and sexual history, including a international erectile function index (IEFI) questionnaire and the Beck Depression Inventory. Serum prolactin, dehydroepiandrosterone sulfate, free testosterone, androstenedione, 17alpha-hydroxyprogesterone, estradiol, free thyroxin and thyrotropin were measured. These variables were compared statistically between the 2 groups.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- 20-45 years old,male patients with active sexual life
Key inclusion criteria (3 listed)
- Male patient with back pain
- 20 - 45 years old
- Active sexual life
Key exclusion criteria (1 listed)
- Younger than 20, older than 45 years old
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2011.
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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.
Gökçen Başaranoğlu, MD principal investigator
Beazialem Vakıf University
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 Marriage, Life Event, run by Bezmialem Vakif 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 3 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 22 Aug 2011. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gokcen Basaranoglu, MD (90 532 589 98 71, gbasaranoglu@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
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 22 Aug 2011.