Polycystic Ovary SyndromePhase 4NCT00640224

Insulin Resistance, Polycystic Ovary Syndrome, and Bone Research Study

A Phase 4 study testing rosiglitazone and drospirenone/ethinyl estradiol in people with Polycystic Ovary Syndrome, run by Silva Arslanian at 1 site in United States.

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

The purpose is to investigate the effects of 2 different treatments (drospirenone/ethinyl estradiol versus rosiglitazone) on insulin sensitivity and androgen levels, inflammatory markers, vascular markers and bone development in overweight adolescent females with polycystic ovary syndrome (PCOS). Read more about this study

Who is it for?: Ages 10 to 20 years, women onlyHealthy volunteers can take part
Conditions the study is for: Polycystic Ovary Syndrome
What is being tested?: rosiglitazone and drospirenone/ethinyl estradiol
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 65 participants
Where: 1 siteUnited States
Study dates: Mar 2005to Jul 2015
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 10 to 20 years
Women only
Healthy volunteers accepted
Child, Adult

Who may be able to join

Age 10 - 20 years
Pubertal level of Tanner stage III-V and menarchal
BMI percentile for age and sex greater than or equal to 85%ile

Who cannot join

Oral medications for PCOS, or that have impact on bone (i.e. anti-epileptics)
Presence of other diseases, systemic or psychiatric, or chronic medications which could interfere with endocrine function
Established diagnosis of diabetes
Prior bone surgery, prior osteoporotic fracture, or fracture in the past 12 months
Prior thromboembolic event, such as a deep venous thrombosis or pulmonary embolism (PCOS subjects only)
Vitamin D deficiency (<10ng/mL)
Hyperkalemia (K>5.0 meq/L)
Positive pregnancy test (serum)

Trial locations and contacts

1 site in 1 country.

United States1 site

Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15224

Other trials in United States

About this study

Official title: Obesity, Insulin Resistance, and Bone Metabolism in Adolescents With PCOS: Effects of Insulin Sensitizers Versus Oral Contraceptives

Read the detailed description

The purpose of this study is to:

to compare effects of treatment with drospirenone/ethinyl estradiol (Yasmin)versus rosiglitazone (Avandia) on hyperandrogenism, insulin resistance/hyperinsulinemia, adrenal hyperresponsiveness, body composition, chronic inflammation, bone mass and turnover.

OCPs are the first-line therapy for PCOS, however, they do not address the insulin resistance or the inflammation. Insulin sensitizers have been used successfully to treat PCOS but thiazolidinediones such as rosiglitazone have not been used in adolescents. Therefore we will investigate the effects of treatment with drospirenone/ethinyl estradiol versus rosiglitazone in overweight adolescents with PCOS. We will obtain comprehensive evaluations before and 6 months after randomization, to the respective treatment arms to determine the differences between the 2 treatment modalities.

Conditions: Polycystic Ovary Syndrome
Being tested: rosiglitazone, drospirenone/ethinyl estradiol
Medical subject headings: Polycystic Ovary Syndrome

What participants receive

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

rosiglitazoneDrug
Also called Avandia
4 mg daily for 6 months
drospirenone/ethinyl estradiolDrug
Also called Yasmin
1 tab (3mg/30mcg) daily for 6 months

Study groups in NCT00640224
Study group	Role	What they receive
Rosiglitazone	Active comparator	Treatment naive overweight adolescent females with PCOS treated with Rosiglitazone Receives: Drug: rosiglitazone
Drospirenone/ethinyl estradiol	Active comparator	Treatment naive overweight adolescent females with PCOS treated with Drospirenone/ethinyl estradiol Receives: Drug: drospirenone/ethinyl estradiol
Overweight/Obese without PCOS	No intervention	Overweight adolescent females without PCOS to use as comparison of normal developmental changes. *No participants were enrolled in this Arm.
Lean without PCOS	No intervention	Lean healthy girls without PCOS to serve as controls for the cardiovascular markers. *No participants were enrolled in this Arm.

What is being measured

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

Peripheral Insulin Sensitivity at Baseline and 6 Months.
Peripheral insulin sensitivity was evaluated during the hyperinsulinemic-euglycemic clamp.
Measured: Baseline and 6 months
Hepatic Insulin Sensitivity at Baseline and 6 Months.
Hepatic insulin sensitivity was evaluated prior to the hyperinsulinemic-euglycemic clamp.
Measured: Baseline and 6 months
Glucose Tolerance Status at Baseline and 6 Months.
Glucose tolerance status was classified according to the ADA (American Diabetes Association) criteria.
Measured: Baseline and 6 months

Secondary outcomes (20)

Total Fat Mass at Baseline and 6 Months
DXA (dual-energy x-ray absorptiometry) scans were done to measure total fat mass.
Measured: Baseline and 6 months
Total Testosterone at Baseline and 6 Months
Total testosterone was measured by HPLC(high-performance liquid chromatography)-tandem mass spectroscopy.
Measured: Baseline and 6 months
Percent Body Fat at Baseline and 6 Months
DXA scans were done to measure the percentage of body fat.
Measured: Baseline and 6 months
Free Testosterone at Baseline and 6 Months
Free testosterone was measured by equilibrium dialysis.
Measured: Baseline and 6 months
SHBG at Baseline and 6 Months
SHBG (sex hormone-binding globulin) was measured by immunoradiometric assay.
Measured: Baseline and 6 months
DHEAS at Baseline and 6 Months
DHEAS (dehydroepiandrosterone sulfate) was measured by radioimmunoassay in dilute serum after hydrolysis.
Measured: Baseline and 6 months
Delta Androstenedione at Baseline and 6 Months
Delta Androstenedione was measured by HPLC-tandem mass spectroscopy.
Measured: Baseline and 6 months
Delta DHEA at Baseline and 6 Months
Delta DHEA was measured by HPLC-tandem mass spectroscopy.
Measured: Baseline and 6 months
Delta 17-OHProg at Baseline and 6 Months
Delta 17-OHProg (17-hydroxyprogesterone) was measured by HPLC-tandem mass spectroscopy.
Measured: Baseline and 6 months
Delta 17-OHPreg at Baseline and 6 Months
Delta 17-OHPreg (17-hydroxypregnenolone) was measured by HPLC-tandem mass spectroscopy.
Measured: Baseline and 6 months
Cholesterol at Baseline and 6 Months
Cholesterol was measured using the standards of the Centers for Disease Control and Prevention.
Measured: Baseline and 6 months
HDL at Baseline and 6 Months
HDL (high-density lipoprotein) was measured using the standards of the Centers for Disease Control and Prevention.
Measured: Baseline and 6 months
LDL at Baseline and 6 Months
LDL (low-density lipoprotein) was measured using the standards of the Centers for Disease Control and Prevention.
Measured: Baseline and 6 months
Triglycerides at Baseline and 6 Months
Triglycerides were measured using the standards of the Centers for Disease Control and Prevention.
Measured: Baseline and 6 months
Non-HDL Cholesterol at Baseline and 6 Months
Non-HDL cholesterol was measured using the standards of the Centers for Disease Control and Prevention.
Measured: Baseline and 6 months
Adiponectin at Baseline and 6 Months
Adiponectin was measured by radioimmunoassay.
Measured: Baseline and 6 months
Leptin at Baseline and 6 Months
Leptin was measured by radioimmunoassay.
Measured: Baseline and 6 months
Hs-CRP at Baseline and 6 Months
hs-CRP(high-sensitivity C-reactive protein) was measured by COAG-Nephelometry.
Measured: Baseline and 6 months
Morning Blood Pressure at Baseline and 6 Months
Morning blood pressure was measured with an automated sphygmomanometer.
Measured: Baseline and 6 months
Night Blood Pressure at Baseline and 6 Months
Night blood pressure was measured with an automated sphygmomanometer.
Measured: Baseline and 6 months

Timeline

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

Mar 2005Jul 2015

First posted21 Mar 2008 (estimated)
Study startMar 2005
Primary completionJul 2015
Study completionJul 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Polycystic Ovary SyndromeStudies 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: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 65 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00640224
Sponsor's protocol ID: 0503013
Other IDs: 2K24HD001357
Status last verified: Oct 2017
First submitted: 18 Mar 2008
Last updated: 17 Nov 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Tfayli H, Ulnach JW, Lee S, Sutton-Tyrrell K, Arslanian S. Drospirenone/ethinyl estradiol versus rosiglitazone treatment in overweight adolescents with polycystic ovary syndrome: comparison of metabolic, hormonal, and cardiovascular risk factors. J Clin Endocrinol Metab. 2011 May;96(5):1311-9. doi: 10.1210/jc.2010-2547. Epub 2011 Feb 16.
PubMed 21325466

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Efficacy of Ovarian Drilling Via vNOTES Laparoscopy in Patients With PCOS
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Efficacy of Injectable Vitamin D Supplementation in Females With Polycystic Ovary Syndrome
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RecruitingObservational study
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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The Effects of the Mediterranean Diet and Synbiotics in Polycystic Ovary Syndrome
PCOS (Polycystic Ovary Syndrome)
Recruiting
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Polycystic Ovary Syndrome (PCOS)

All Polycystic Ovary Syndrome trials

Study at a glance

From the registry record, last updated by the sponsor on 17 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Obesity, Insulin Resistance, and Bone Metabolism in Adolescents With PCOS: Effects of Insulin Sensitizers Versus Oral Contraceptives
ClinicalTrials.gov ID: NCT00640224
Acronym / sponsor ID: 0503013
Conditions: Polycystic Ovary Syndrome
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 65 participants (actual)
Lead sponsor: Silva ArslanianUniversity, hospital or other
Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Study start: Mar 2005
Primary completion: Jul 2015 (actual)
Study completion: Jul 2015 (actual)
First posted: 21 Mar 2008 (estimated)
Results: Posted 17 Nov 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

The purpose of this study is to:

to compare effects of treatment with drospirenone/ethinyl estradiol (Yasmin)versus rosiglitazone (Avandia) on hyperandrogenism, insulin resistance/hyperinsulinemia, adrenal hyperresponsiveness, body composition, chronic inflammation, bone mass and turnover.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
Rosiglitazone	Active comparator	Drug: rosiglitazoneTreatment naive overweight adolescent females with PCOS treated with Rosiglitazone
Drospirenone/ethinyl estradiol	Active comparator	Drug: drospirenone/ethinyl estradiolTreatment naive overweight adolescent females with PCOS treated with Drospirenone/ethinyl estradiol
Overweight/Obese without PCOS	No intervention	–Overweight adolescent females without PCOS to use as comparison of normal developmental changes. *No participants were enrolled in this Arm.
Lean without PCOS	No intervention	–Lean healthy girls without PCOS to serve as controls for the cardiovascular markers. *No participants were enrolled in this Arm.

Who may qualify

Ages: 10 to 20 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Child, Adult

Key inclusion criteria (3 listed)

Age 10 - 20 years
Pubertal level of Tanner stage III-V and menarchal
BMI percentile for age and sex greater than or equal to 85%ile

Key exclusion criteria (8 listed)

Oral medications for PCOS, or that have impact on bone (i.e. anti-epileptics)
Presence of other diseases, systemic or psychiatric, or chronic medications which could interfere with endocrine function
Established diagnosis of diabetes
Prior bone surgery, prior osteoporotic fracture, or fracture in the past 12 months
Prior thromboembolic event, such as a deep venous thrombosis or pulmonary embolism (PCOS subjects only)

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
rosiglitazoneAlso: Avandia4 mg daily for 6 months	Drug	Rosiglitazone
drospirenone/ethinyl estradiolAlso: Yasmin1 tab (3mg/30mcg) daily for 6 months	Drug	Drospirenone/ethinyl estradiol

Primary outcome

Peripheral Insulin Sensitivity at Baseline and 6 Months.
Time frame: Baseline and 6 months
Peripheral insulin sensitivity was evaluated during the hyperinsulinemic-euglycemic clamp.
Hepatic Insulin Sensitivity at Baseline and 6 Months.
Time frame: Baseline and 6 months
Hepatic insulin sensitivity was evaluated prior to the hyperinsulinemic-euglycemic clamp.
Glucose Tolerance Status at Baseline and 6 Months.
Time frame: Baseline and 6 months
Glucose tolerance status was classified according to the ADA (American Diabetes Association) criteria.

20 secondary outcomes

Total Fat Mass at Baseline and 6 Months
Time frame: Baseline and 6 months
Total Testosterone at Baseline and 6 Months
Time frame: Baseline and 6 months
Percent Body Fat at Baseline and 6 Months
Time frame: Baseline and 6 months
Free Testosterone at Baseline and 6 Months
Time frame: Baseline and 6 months
SHBG at Baseline and 6 Months
Time frame: Baseline and 6 months
DHEAS at Baseline and 6 Months
Time frame: Baseline and 6 months
Delta Androstenedione at Baseline and 6 Months
Time frame: Baseline and 6 months
Delta DHEA at Baseline and 6 Months
Time frame: Baseline and 6 months
Delta 17-OHProg at Baseline and 6 Months
Time frame: Baseline and 6 months
Delta 17-OHPreg at Baseline and 6 Months
Time frame: Baseline and 6 months
Cholesterol at Baseline and 6 Months
Time frame: Baseline and 6 months
HDL at Baseline and 6 Months
Time frame: Baseline and 6 months
LDL at Baseline and 6 Months
Time frame: Baseline and 6 months
Triglycerides at Baseline and 6 Months
Time frame: Baseline and 6 months
Non-HDL Cholesterol at Baseline and 6 Months
Time frame: Baseline and 6 months
Adiponectin at Baseline and 6 Months
Time frame: Baseline and 6 months
Leptin at Baseline and 6 Months
Time frame: Baseline and 6 months
Hs-CRP at Baseline and 6 Months
Time frame: Baseline and 6 months
Morning Blood Pressure at Baseline and 6 Months
Time frame: Baseline and 6 months
Night Blood Pressure at Baseline and 6 Months
Time frame: Baseline and 6 months

Results and safety

Results posted to the registry on 17 Nov 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Rosiglitazone	23	17
Drospirenone/Ethinyl Estradiol	23	20
Overweight/Obese Without PCOS	0	0
Lean Without PCOS	0	0

Primary outcome: Peripheral Insulin Sensitivity at Baseline and 6 Months.

Time frame: Baseline and 6 months. Mean (Standard Error). Unit: mg/kg/min per uU/mL

Measure	Rosiglitazone n = 17	Drospirenone/Ethinyl Estradiol n = 20	Overweight/Obese Without PCOS n = 0	Lean Without PCOS n = 0
Peripheral insulin sensitivity, Baseline	2.2 (0.2)	2.1 (0.2)	–	–
Peripheral insulin sensitivity, 6 months	3.2 (0.4)	2.0 (0.2)	–	–

Primary outcome: Hepatic Insulin Sensitivity at Baseline and 6 Months.

Time frame: Baseline and 6 months. Mean (Standard Error). Unit: (mg/kg/min x uU/mL)-1

Measure	Rosiglitazone n = 17	Drospirenone/Ethinyl Estradiol n = 20	Overweight/Obese Without PCOS n = 0	Lean Without PCOS n = 0
Hepatic insulin sensitivity, Baseline	17.3 (1.8)	17.4 (2.2)	–	–
Hepatic insulin sensitivity, 6 months	24.1 (3.4)	16.8 (2.2)	–	–

Primary outcome: Glucose Tolerance Status at Baseline and 6 Months.

Time frame: Baseline and 6 months. Count of participants. Unit: Participants

Measure	Rosiglitazone n = 17	Drospirenone/Ethinyl Estradiol n = 20	Overweight/Obese Without PCOS n = 0	Lean Without PCOS n = 0
Normal glucose tolerance, baseline	15	12	–	–
Impaired glucose tolerance, baseline	2	8	–	–
Normal glucose tolerance, 6 months	15	13	–	–
Impaired glucose tolerance, 6 months	2	7	–	–

20 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Rosiglitazone	0 of 17 (0%)	0 of 17 (0%)	Not reported
Drospirenone/Ethinyl Estradiol	0 of 20 (0%)	0 of 20 (0%)	Not reported
Overweight/Obese Without PCOS	0 of 0	0 of 0	Not reported
Lean Without PCOS	0 of 0	0 of 0	Not reported

Limitations and caveats (from the sponsor): The potential unblinding due to the rapid regulation of withdrawal bleeding which may have influenced the dropout rates;the short duration of treatment in contrast to clinical practice where treatment may be for several years.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 21325466Tfayli H, Ulnach JW, Lee S, Sutton-Tyrrell K, Arslanian S. Drospirenone/ethinyl estradiol versus rosiglitazone treatment in overweight adolescents with polycystic ovary syndrome: comparison of metabolic, hormonal, and cardiovascular risk factors. J Clin Endocrinol Metab. 2011 May;96(5):1311-9. doi: 10.1210/jc.2010-2547. Epub 2011 Feb 16.

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
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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.

Silva Arslanian, M.D. principal investigator

University of Pittsburgh

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing rosiglitazone and drospirenone/ethinyl estradiol in people with Polycystic Ovary Syndrome, run by Silva Arslanian at 1 site in United States.

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 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 17 Nov 2017. 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 United States. 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?

Yes. Results are posted in the registry (first posted 17 Nov 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Peripheral Insulin Sensitivity at Baseline and 6 Months. (time frame: Baseline and 6 months). The study lists 3 primary outcomes in all. 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 NCT00640224, which also lists 1 linked publication.

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 17 Nov 2017.