Polycystic Ovary SyndromeNCT04043221
Long Term Metformin in Women With Polycystic Ovary Syndrome
An observational study of Polycystic Ovary Syndrome, run by University Medical Centre Ljubljana at 1 site in Slovenia.
Trial summary
The investigators analyzed collection data of 10 years for the efficacy of metformin on body mass, menstrual frequencies, metabolic and hormonal outcomes in women with polycystic ovary syndrome (PCOS) and BMI ≥ 25kg/m2. Each patient's age and height were recorded at baseline. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women only
- Conditions the study is for
- Polycystic Ovary Syndrome
- How many people
- 180 participants
- Where
- 1 siteSlovenia
- Study dates
- 1 Jan 2006to 1 Jan 2019
- 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 18 to 55 years
- Women only
- No healthy volunteers
- Adult
Study population: Collection data from endocrine outpatient clinic for 10 years of women with PCOS phenotype A, BMI≥ 25kg/m2, all receiving monotherapy with metformin 1000 mg twice a day.
Who may be able to join
- PCOS phenotype A
- BMI≥ 25kg/m2
- metformin 1000mg twice a day for at least one year
Who cannot join
- PCOS phenotype B, C, D
- BMI <25kg/m2
- had been treated with spironolactone or oral contraceptives alone or in combination with metformin
- had history of bariatric surgery
- became pregnant during the observation period
- had inability to tolerate metformin, leading to the cessation of drug therapy within first follow up year
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Long Term Treatment With Metformin on Clinical, Metabolic and Endocrine Parameters in Women With Polycystic Ovary Syndrome And Increased Metabolic Risk
The investigators analyzed collection data of 10 years for the efficacy of metformin on body mass, menstrual frequencies, metabolic and hormonal outcomes in women with polycystic ovary syndrome (PCOS) and BMI ≥ 25kg/m2.
Each patient's age and height were recorded at baseline. In addition each patient weight, waist circumference, menstrual regularity, fasting glucose, glucose after 120 minute oral glucose tolerance test, luteinizing hormone, follicle stimulating hormone , free and direct testosterone, androstenedione, sex hormone binding globulin, dehydroepiandrosterone sulfate were identified at baseline and at the every follow up visit where available.
- Conditions
- Polycystic Ovary Syndrome
- Medical subject headings
- Polycystic Ovary Syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
body weight
Primary outcome was change in body weight.
Measured: The measurement is assessed in kilograms at the beginning and after every year of taking metformin for 10 years.
menstrual frequency
Primary outcome was change in menstrual frequency.
Measured: The measurement is assessed in number of bleeds per year at the beginning and after every year of taking metformin for 10 years.
free testosterone
Primary outcome was change in levels of free testosterone.
Measured: The measurement is assessed in nmol/L at the beginning and after every year of taking metformin for 10 years.
diabetes mellitus
Primary outcome was development of diabetes mellitus.
Measured: The measurement of glucose in blood is assessed in mmol/L at the beginning and after every year of taking metformin for 10 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2019
- Study start1 Jan 2006
- Primary completion1 Dec 2008
- Study completion1 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polycystic Ovary SyndromeStudies of the same condition, open and under way.
- More trials run by University Medical Centre LjubljanaThe 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
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medical Centre Ljubljana
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrej Janez, University Medical Centre Ljubljana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04043221
- Sponsor's protocol ID
- MET retro
- Status last verified
- Aug 2019
- First submitted
- 9 Jul 2019
- Last updated
- 2 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Long Term Treatment With Metformin on Clinical, Metabolic and Endocrine Parameters in Women With Polycystic Ovary Syndrome And Increased Metabolic Risk
- ClinicalTrials.gov ID
- NCT04043221
- Acronym / sponsor ID
- MET retro
- Conditions
- Polycystic Ovary Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- University Medical Centre LjubljanaUniversity, hospital or other
- Study start
- 1 Jan 2006 (actual)
- Primary completion
- 1 Dec 2008 (actual)
- Study completion
- 1 Jan 2019 (actual)
- First posted
- 2 Aug 2019 (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.
The investigators analyzed collection data of 10 years for the efficacy of metformin on body mass, menstrual frequencies, metabolic and hormonal outcomes in women with polycystic ovary syndrome (PCOS) and BMI ≥ 25kg/m2.
Each patient's age and height were recorded at baseline. In addition each patient weight, waist circumference, menstrual regularity, fasting glucose, glucose after 120 minute oral glucose tolerance test, luteinizing hormone, follicle stimulating hormone , free and direct testosterone, androstenedione, sex hormone binding globulin, dehydroepiandrosterone sulfate were identified at baseline and at the every follow up visit where available.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Collection data from endocrine outpatient clinic for 10 years of women with PCOS phenotype A, BMI≥ 25kg/m2, all receiving monotherapy with metformin 1000 mg twice a day.
Key inclusion criteria (3 listed)
- PCOS phenotype A
- BMI≥ 25kg/m2
- metformin 1000mg twice a day for at least one year
Key exclusion criteria (6 listed)
- PCOS phenotype B, C, D
- BMI <25kg/m2
- had been treated with spironolactone or oral contraceptives alone or in combination with metformin
- had history of bariatric surgery
- became pregnant during the observation period
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
body weight
Time frame: The measurement is assessed in kilograms at the beginning and after every year of taking metformin for 10 years.
Primary outcome was change in body weight.
menstrual frequency
Time frame: The measurement is assessed in number of bleeds per year at the beginning and after every year of taking metformin for 10 years.
Primary outcome was change in menstrual frequency.
free testosterone
Time frame: The measurement is assessed in nmol/L at the beginning and after every year of taking metformin for 10 years.
Primary outcome was change in levels of free testosterone.
diabetes mellitus
Time frame: The measurement of glucose in blood is assessed in mmol/L at the beginning and after every year of taking metformin for 10 years.
Primary outcome was development of diabetes mellitus.
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 2 Aug 2019.
Related trials for Polycystic Ovary Syndrome
Recruiting
Efficacy of Ovarian Drilling Via vNOTES Laparoscopy in Patients With PCOS
PCOS (Polycystic Ovary Syndrome)
RecruitingPhase 1
Efficacy of Injectable Vitamin D Supplementation in Females With Polycystic Ovary Syndrome
Anovulatory Infertility
RecruitingObservational study
The Value of LC-MS/MS Detection of Androgen Profiles in the Diagnosis of PCOS: A Prospective, Multicenter Real-world Study
Polycystic Ovary Syndrome (PCOS)
Recruiting
The Effects of the Mediterranean Diet and Synbiotics in Polycystic Ovary Syndrome
PCOS (Polycystic Ovary Syndrome)
Recruiting
Brown Adipose Tissue Modulation in Polycystic Ovary Syndrome Using Infrared Thermography
Polycystic Ovary Syndrome (PCOS)
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?
An observational study of Polycystic Ovary Syndrome, run by University Medical Centre Ljubljana at 1 site in Slovenia.
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 6 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 2 Aug 2019. 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 Slovenia. 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?
body weight (time frame: The measurement is assessed in kilograms at the beginning and after every year of taking metformin for 10 years.). The study lists 4 primary outcomes in all. 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 2 Aug 2019.