Polycystic Ovary SyndromeNCT00172523
Metabolic Disorders in Polycystic Ovarian Syndrome
An observational study of Polycystic Ovary Syndrome, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
The purpose of this study is to elucidate the significance of adipocytokine in women with PCOS among adiposity, hyperandrogenism and insulin resistance. Read more about this study
- Who is it for?
- Ages 17 to 40 years, women only
- Conditions the study is for
- Polycystic Ovary Syndrome
- How many people
- Not given
- Where
- 1 siteTaiwan
- Study dates
- Oct 2004to Aug 2005
- 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 17 to 40 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- 1. Oligomenorrhea ( less than 6 times spontaneous MC per year) or Amenorrhea. 2. Hyperandrogenism (either clinical or biochemistry. 3. PCO by ultrasound. 4.After menarche, before menopause.
Who cannot join
- 1. hormone therapy in the past 6 months. 2. Pregnancy in the past 6 months 3.Acute illness found in the past 3 months. 4.Systemic disease including autoimmune disease, malignancy, hepatic, renal or CVS disease, and ever received chemotherapy or immunosuppressive agents.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Department of Obstetrics and Gynecology, National Taiwan University Hospital
Taipei
Mei-Jou Chen, M.D., 886-2-23123456 ext. 3950, metro@ha.mc.tnu.edu.tw
About this study
The purpose of this study is to elucidate the significance of adipocytokine in women with PCOS among adiposity, hyperandrogenism and insulin resistance.
Read the detailed description
Polycystic ovary syndrome (PCOS) is the most common endocrinopathy in women of reproductive age with a probable prevalence of 5% to 10%. PCOS is characterized by chronic anovulation, menstrual irregularities, evidence of hyperandrogenism (either clinical, manifested as hirsutism, acne, male pattern balding, or biochemical, manifested by elevated serum adrenal and/or ovarian androgen concentration). Fifty percent of all patients with PCOS are obese, and the presence of obesity affects the clinical manifestations of PCOS. The underlying pathogenic mechanisms appear to involve insulin resistance and hyperinsulinemia, the magnitude of which is greater in obese than in non-obese women with PCOS.
- Conditions
- Polycystic Ovary Syndrome
- Medical subject headings
- Polycystic Ovary Syndrome
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startOct 2004
- Study completionAug 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Polycystic Ovary SyndromeStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe 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
- Defined population
- Time perspective
- Other
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Horng-Nerng Ho, M.D., Study director, NTUH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00172523
- Sponsor's protocol ID
- 9361701094
- Status last verified
- Oct 2004
- First submitted
- 12 Sep 2005
- Last updated
- 15 Sep 2005
- Results posted
- No
Publications
Yang PK, Chou CH, Chang CH, Chen SU, Ho HN, Chen MJ. Changes in peripheral mitochondrial DNA copy number in metformin-treated women with polycystic ovary syndrome: a longitudinal study. Reprod Biol Endocrinol. 2020 Jul 13;18(1):69. doi: 10.1186/s12958-020-00629-5.
PubMed 32660613Yang PK, Hsu CY, Chen MJ, Lai MY, Li ZR, Chen CH, Chen SU, Ho HN. The Efficacy of 24-Month Metformin for Improving Menses, Hormones, and Metabolic Profiles in Polycystic Ovary Syndrome. J Clin Endocrinol Metab. 2018 Mar 1;103(3):890-899. doi: 10.1210/jc.2017-01739.
PubMed 29325133
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolic Disorders in Polycystic Ovarian Syndrome
- ClinicalTrials.gov ID
- NCT00172523
- Acronym / sponsor ID
- 9361701094
- Conditions
- Polycystic Ovary Syndrome
- Study type
- Observational
- Recruitment status
- Unknown status
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Oct 2004
- Study completion
- Aug 2005
- First posted
- 15 Sep 2005 (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.
The purpose of this study is to elucidate the significance of adipocytokine in women with PCOS among adiposity, hyperandrogenism and insulin resistance.
Detailed description
Polycystic ovary syndrome (PCOS) is the most common endocrinopathy in women of reproductive age with a probable prevalence of 5% to 10%. PCOS is characterized by chronic anovulation, menstrual irregularities, evidence of hyperandrogenism (either clinical, manifested as hirsutism, acne, male pattern balding, or biochemical, manifested by elevated serum adrenal and/or ovarian androgen concentration). Fifty percent of all patients with PCOS are obese, and the presence of obesity affects the clinical manifestations of PCOS. The underlying pathogenic mechanisms appear to involve insulin resistance and hyperinsulinemia, the magnitude of which is greater in obese than in non-obese women with PCOS.
Study design
- Observational model
- Defined population
- Time perspective
- Other
Who may qualify
- Ages
- 17 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- 1. Oligomenorrhea ( less than 6 times spontaneous MC per year) or Amenorrhea. 2. Hyperandrogenism (either clinical or biochemistry. 3. PCO by ultrasound. 4.After menarche, before menopause.
Key exclusion criteria (1 listed)
- 1. hormone therapy in the past 6 months. 2. Pregnancy in the past 6 months 3.Acute illness found in the past 3 months. 4.Systemic disease including autoimmune disease, malignancy, hepatic, renal or CVS disease, and ever received chemotherapy or immunosuppressive agents.
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 15 Sep 2005.
- Derived from this study: PubMed 32660613Yang PK, Chou CH, Chang CH, Chen SU, Ho HN, Chen MJ. Changes in peripheral mitochondrial DNA copy number in metformin-treated women with polycystic ovary syndrome: a longitudinal study. Reprod Biol Endocrinol. 2020 Jul 13;18(1):69. doi: 10.1186/s12958-020-00629-5.
- Derived from this study: PubMed 29325133Yang PK, Hsu CY, Chen MJ, Lai MY, Li ZR, Chen CH, Chen SU, Ho HN. The Efficacy of 24-Month Metformin for Improving Menses, Hormones, and Metabolic Profiles in Polycystic Ovary Syndrome. J Clin Endocrinol Metab. 2018 Mar 1;103(3):890-899. doi: 10.1210/jc.2017-01739.
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The Value of LC-MS/MS Detection of Androgen Profiles in the Diagnosis of PCOS: A Prospective, Multicenter Real-world Study
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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.
Horng-Nerng Ho, M.D. study director
NTUH
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 National Taiwan University Hospital at 1 site in Taiwan.
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 1 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 15 Sep 2005. 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 Taiwan. 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 Mei-Jou Chen, M.D. (886-2-23123456 ext. 3950, metro@ha.mc.ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00172523, which also lists 2 linked publications.
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 15 Sep 2005.