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Polycystic Ovary SyndromePhase 4NCT00145340

Pioglitazone Treatment in Polycystic Ovary Syndrome

A Phase 4 study testing pioglitazone in people with Polycystic Ovary Syndrome, run by Odense University Hospital at 1 site in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

In this study, the investigators wish to investigate how pioglitazone treatment effects hirsute women. Hirsute women are often overweight and have an increased amount of male sex hormone in their blood. Their blood tests show frequent changes corresponding to the changes seen in diabetic patients. Read more about this study

Who is it for?
Ages 18 to 45 years, women only
Conditions the study is for
Polycystic Ovary Syndrome
What is being tested?
pioglitazone
How many people
30 participants
Where
1 siteDenmark
Study dates
Sep 2002to Jan 2007
Phase
Phase 4
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 45 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • Irregular menses, i.e. cyclus length of >36 days
  • Premenopausal
  • Increased fasting insulin > 50 pmol/l
  • Increased free testosterone > 0.035 nmol/l

Who cannot join

  • Age: <18 years
  • Contraceptive pill within the past 3 months
  • Postmenopausal (increased FSH)
  • Known diabetes mellitus, endocrine disease or other disease requiring treatment
  • Drug use
  • Pregnancy
  • Planned pregnancy during the treatment period
  • Increased liver parameters

Trial locations and contacts

1 site in 1 country.

Denmark1 site

  • Department of Endocrinology, Odense University Hospital

    Odense, Funen, 5000

Other trials in Denmark

About this study

Official title: The Effect of PPARgamma Stimulation on Glucose Metabolism, Insulin Resistance, Growth Hormone and Cortisol on Women Suffering From Polycystic Ovary Syndrome

In this study, the investigators wish to investigate how pioglitazone treatment effects hirsute women. Hirsute women are often overweight and have an increased amount of male sex hormone in their blood. Their blood tests show frequent changes corresponding to the changes seen in diabetic patients.

Pioglitazone is a drug used for increasing the insulin sensitivity in diabetic patients. Previous studies showed that this drug is able to decrease the level of insulin in blood in hirsute women. Moreover, the level of male sex hormones is reduced during this treatment. The drug has only been marketed for few years, and no investigations have been carried out as to the reaction of other hormones, e.g. growth hormone and stress hormone, using this treatment.

Read more

This clinical trial includes 30 strongly hirsute women. The patients are randomized to either placebo or an active drug. The treatment period is 16 weeks. The patients included must be healthy and take no medicine possibly changing the results of the study. The patients must take no contraceptive pills or receive any other hormone treatment.

In connection with the investigation, the following will be carried out on all patients: glucose tolerance test, clinical examination, blood tests, measurement of stress hormones and sex hormones, hyperinsulinaemic euglycaemic clamp test, muscle biopsies and bone scan.

This examination programme will be carried out before start of pioglitazone or placebo treatment and again after 16 weeks of treatment. The examinations require 2½ days of hospitalization.

The purpose of the study is to gain more knowledge of the reasons for hirsute women to grow more hair than normal women. The study will show whether pioglitazone treatment can reduce the amount of male sex hormone in blood and how the level of stress hormone and growth hormone is changed when reducing the amount of insulin in blood.

Being tested
pioglitazone
Keywords
polycystic ovary syndrome (PCOS), PPARgamma, growth hormone, insulin resistance, pioglitazone, glucose metabolism, microarray
Medical subject headings
Polycystic Ovary Syndrome, Carotid Intimal Medial Thickness 1, Insulin Resistance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Glucose infusion rate (M value) below euglycaemic hyperinsulinaemic clamp (comparing baseline with 4 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Sep 2005 (estimated)
  2. Study startSep 2002
  3. Primary completionJan 2007
  4. Study completionJan 2007

Resources

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 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Enrolment
30 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00145340
Sponsor's protocol ID
032
Status last verified
Sep 2008
First submitted
2 Sep 2005
Last updated
26 Sep 2008
Results posted
No
Data monitoring committee
Yes

Publications

  • Glintborg D, Petersen MH, Ravn P, Hermann AP, Andersen M. Comparison of regional fat mass measurement by whole body DXA scans and anthropometric measures to predict insulin resistance in women with polycystic ovary syndrome and controls. Acta Obstet Gynecol Scand. 2016 Nov;95(11):1235-1243. doi: 10.1111/aogs.12964.

    PubMed 27529295

  • Glintborg D, Hermann AP, Rasmussen LM, Andersen M. Plasma osteoprotegerin is associated with testosterone levels but unaffected by pioglitazone treatment in patients with polycystic ovary syndrome. J Endocrinol Invest. 2013 Jul-Aug;36(7):460-5. doi: 10.3275/8767. Epub 2012 Nov 26.

    PubMed 23211475

  • Vigerust NF, Bohov P, Bjorndal B, Seifert R, Nygard O, Svardal A, Glintborg D, Berge RK, Gaster M. Free carnitine and acylcarnitines in obese patients with polycystic ovary syndrome and effects of pioglitazone treatment. Fertil Steril. 2012 Dec;98(6):1620-6.e1. doi: 10.1016/j.fertnstert.2012.08.024. Epub 2012 Sep 19.

    PubMed 22999793

  • Eriksen M, Porneki AD, Skov V, Burns JS, Beck-Nielsen H, Glintborg D, Gaster M. Insulin resistance is not conserved in myotubes established from women with PCOS. PLoS One. 2010 Dec 30;5(12):e14469. doi: 10.1371/journal.pone.0014469.

    PubMed 21209881

  • Glintborg D, Hojlund K, Andersen NR, Hansen BF, Beck-Nielsen H, Wojtaszewski JF. Impaired insulin activation and dephosphorylation of glycogen synthase in skeletal muscle of women with polycystic ovary syndrome is reversed by pioglitazone treatment. J Clin Endocrinol Metab. 2008 Sep;93(9):3618-26. doi: 10.1210/jc.2008-0760. Epub 2008 Jun 10.

    PubMed 18544618

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing pioglitazone in people with Polycystic Ovary Syndrome, run by Odense University Hospital at 1 site in Denmark.

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 4 inclusion and 8 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 26 Sep 2008. 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 Denmark. 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

Glucose infusion rate (M value) below euglycaemic hyperinsulinaemic clamp (comparing baseline with 4 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00145340, which also lists 5 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 26 Sep 2008.

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