Polycystic Ovary SyndromeNCT00442689

Metabolic Syndrome in PCOS: Precursors and Interventions

A study testing flutamide and ethinyl estradiol 35 mcg and drospirenone 3 mg in people with Polycystic Ovary Syndrome and Metabolic Syndrome, run by Northwestern University 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

Who is it for?: Ages 18 to 35 years, women only
Conditions the study is for: Polycystic Ovary Syndrome, Metabolic Syndrome
What is being tested?: flutamide and ethinyl estradiol 35 mcg and drospirenone 3 mg
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 97 participants
Where: 1 siteUnited States
Study dates: Jul 2006to Nov 2012
Phase: Interventional
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 18 to 35 years
Women only
No healthy volunteers
Adult

Who may be able to join

6 periods or fewer per year
Overweight
All ethnicities

Who cannot join

Diabetes
Heart Disease
Chronic illness
Regular Smokers
Current use of Birth Control Pills, Patch, Ring, Depo

Trial locations and contacts

1 site in 1 country.

United States1 site

Northwestern Memorial Hospital
Chicago, Illinois, 60611

Other trials in United States

About this study

The purpose of this study is to investigate the metabolic effects of anti-androgens and oral contraceptive pills (OCPs), compared with placebo, in the treatment of women with PCOS. We hypothesized that controlling elevated androgen levels with either anti-androgens or OCPs would produce improvement in metabolic markers in PCOS women and would reduce their long term metabolic risk.

Read the detailed description

Polycystic ovary syndrome (PCOS) is one of the most common conditions of young women, and it is frequently associated with insulin resistance or metabolic syndrome (MBS). In addition, affected women have significantly elevated mean low-density lipoprotein (LDL) levels and an increased prevalence of at risk LDL levels, independent of obesity. We are directly testing the role of androgens in the metabolic abnormalities in PCOS by examining the impact of direct androgen receptor blockade by anti-androgen medications and indirect suppression of androgen production through suppression of leutinizing hormone (LH) with oral contraceptive pills (OCPs), compared with placebo, on visceral adiposity, circulating LDL levels, insulin secretion and sensitivity as measured by frequently-sampled IV glucose tolerance tests (FSIGT) and oral glucose tolerance tests (OGTT), resting energy expenditure, and maximal aerobic capacity measurement.

Note: Originally there were 2 additional study arm, Metformin only and Metformin + Flutamide. These study arms were ultimately eliminated and were not included in analysis of baseline characteristics or endpoints.

Conditions: Polycystic Ovary Syndrome, Metabolic Syndrome
Being tested: flutamide, ethinyl estradiol 35 mcg and drospirenone 3 mg, placebo
Keywords: Polycystic Ovary Syndrome, Metabolic Syndrome, PCOS, overweight, infertility, Insulin Resistance, menstrual cycle
Medical subject headings: Polycystic Ovary Syndrome, Metabolic Syndrome, Overweight, Infertility, Insulin Resistance

What participants receive

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

flutamideDrug
Also called Eulexin
250 mg twice daily
ethinyl estradiol 35 mcg and drospirenone 3 mgDrug
Also called Yasmin
one active pill per day for three weeks and then 1 sugar pill per day for one week
placeboOther
Also called sugar pill

Study groups in NCT00442689
Study group	Role	What they receive
1	Experimental	oral contraceptive (35 mg ethinyl estradiol) Receives: Drug: ethinyl estradiol 35 mcg and drospirenone 3 mg
2	Experimental	Flutamide 250 mg twice daily Receives: Drug: flutamide
3	Placebo comparator	Placebo Receives: Other: placebo

What is being measured

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

Change in Low-density Lipoprotein (LDL) Levels Over the Study Period
Change in low-density lipoprotein (LDL) levels over the study period (LDL level at study endpoint - baseline LDL level)
Measured: 6 months
Change in High-density Lipoprotein (HDL) Levels During Study Period
Change in high-density lipoprotein (HDL) levels during study period (HDL level at study endpoint - baseline HDL)
Measured: 6 months
Change in Visceral Adipose Tissue (VAT) Volume as Measured by MRI
Change in visceral adipose tissue (VAT) volume as measured by MRI (VAT at study endpoint - baseline VAT)
Measured: 6 months
Change in Fat Percentage as Measured by Dual-energy X-ray Absorptiometry (DEXA) Scan Over the Study Period
Change in fat percentage as measured by DEXA scan over the study period (Fat percentage at study endpoint - baseline fat percentage)
Measured: 6 months
Change in Disposition Index
Change in disposition index (DI, insulin secretion corrected for insulin secretion) as measured by frequently-sampled IV glucose tolerance test (DI at study endpoint - baseline DI)
Measured: 6 months
Change in Resting Energy Expenditure (REE) Over the Study Period
Change in resting energy expenditure (REE) over the study period (REE at study endpoint - baseline REE)
Measured: 6 months
Change in Maximal Aerobic Exercise Capacity (VO2 Max) Over the Study Period
Change in maximal aerobic exercise capacity (VO2 max) over the study period (VO2 max at study endpoint - baseline VO2 max)
Measured: 6 months

Timeline

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

Jul 2006Nov 2012

First posted2 Mar 2007 (estimated)
Study startJul 2006
Primary completionNov 2012
Study completionNov 2012

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 (4)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 Northwestern 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: Interventional
Phase: Phase N/A
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 97 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00442689
Sponsor's protocol ID: DK73411
Other IDs: R01DK073411
Status last verified: May 2014
First submitted: 5 Feb 2007
Last updated: 6 Jun 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Diamanti-Kandarakis E, Mitrakou A, Raptis S, Tolis G, Duleba AJ. The effect of a pure antiandrogen receptor blocker, flutamide, on the lipid profile in the polycystic ovary syndrome. J Clin Endocrinol Metab. 1998 Aug;83(8):2699-705. doi: 10.1210/jcem.83.8.5041.
PubMed 9709934
Gambineri A, Patton L, Vaccina A, Cacciari M, Morselli-Labate AM, Cavazza C, Pagotto U, Pasquali R. Treatment with flutamide, metformin, and their combination added to a hypocaloric diet in overweight-obese women with polycystic ovary syndrome: a randomized, 12-month, placebo-controlled study. J Clin Endocrinol Metab. 2006 Oct;91(10):3970-80. doi: 10.1210/jc.2005-2250. Epub 2006 Jul 25.
PubMed 16868063
Gambineri A, Pelusi C, Genghini S, Morselli-Labate AM, Cacciari M, Pagotto U, Pasquali R. Effect of flutamide and metformin administered alone or in combination in dieting obese women with polycystic ovary syndrome. Clin Endocrinol (Oxf). 2004 Feb;60(2):241-9. doi: 10.1111/j.1365-2265.2004.01973.x.
PubMed 14725687
Urbanek M, Sam S, Legro RS, Dunaif A. Identification of a polycystic ovary syndrome susceptibility variant in fibrillin-3 and association with a metabolic phenotype. J Clin Endocrinol Metab. 2007 Nov;92(11):4191-8. doi: 10.1210/jc.2007-0761. Epub 2007 Sep 4.
PubMed 17785364

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

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)

All Polycystic Ovary Syndrome trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Metabolic Syndrome in PCOS: Precursors and Interventions
ClinicalTrials.gov ID: NCT00442689
Acronym / sponsor ID: DK73411
Conditions: Polycystic Ovary Syndrome, Metabolic Syndrome
Keywords: Polycystic Ovary Syndrome, Metabolic Syndrome, PCOS, overweight, infertility, Insulin Resistance, menstrual cycle
Study type: Interventional
Recruitment status: Completed
Enrolment: 97 participants (actual)
Lead sponsor: Northwestern UniversityUniversity, hospital or other
Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study start: Jul 2006
Primary completion: Nov 2012 (actual)
Study completion: Nov 2012 (actual)
First posted: 2 Mar 2007 (estimated)
Results: Posted 6 Jun 2014

Clinical summary

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

Detailed description

Study design

Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
1	Experimental	Drug: ethinyl estradiol 35 mcg and drospirenone 3 mgoral contraceptive (35 mg ethinyl estradiol)
2	Experimental	Drug: flutamideFlutamide 250 mg twice daily
3	Placebo comparator	Other: placeboPlacebo

Who may qualify

Ages: 18 to 35 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (3 listed)

6 periods or fewer per year
Overweight
All ethnicities

Key exclusion criteria (5 listed)

Diabetes
Heart Disease
Chronic illness
Regular Smokers
Current use of Birth Control Pills, Patch, Ring, Depo

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
flutamideAlso: Eulexin250 mg twice daily	Drug	2
ethinyl estradiol 35 mcg and drospirenone 3 mgAlso: Yasminone active pill per day for three weeks and then 1 sugar pill per day for one week	Drug	1
placeboAlso: sugar pill	Other	3

Primary outcome

Change in Low-density Lipoprotein (LDL) Levels Over the Study Period
Time frame: 6 months
Change in low-density lipoprotein (LDL) levels over the study period (LDL level at study endpoint - baseline LDL level)
Change in High-density Lipoprotein (HDL) Levels During Study Period
Time frame: 6 months
Change in high-density lipoprotein (HDL) levels during study period (HDL level at study endpoint - baseline HDL)
Change in Visceral Adipose Tissue (VAT) Volume as Measured by MRI
Time frame: 6 months
Change in visceral adipose tissue (VAT) volume as measured by MRI (VAT at study endpoint - baseline VAT)
Change in Fat Percentage as Measured by Dual-energy X-ray Absorptiometry (DEXA) Scan Over the Study Period
Time frame: 6 months
Change in fat percentage as measured by DEXA scan over the study period (Fat percentage at study endpoint - baseline fat percentage)
Change in Disposition Index
Time frame: 6 months
Change in disposition index (DI, insulin secretion corrected for insulin secretion) as measured by frequently-sampled IV glucose tolerance test (DI at study endpoint - baseline DI)
Change in Resting Energy Expenditure (REE) Over the Study Period
Time frame: 6 months
Change in resting energy expenditure (REE) over the study period (REE at study endpoint - baseline REE)
Change in Maximal Aerobic Exercise Capacity (VO2 Max) Over the Study Period
Time frame: 6 months
Change in maximal aerobic exercise capacity (VO2 max) over the study period (VO2 max at study endpoint - baseline VO2 max)

Results and safety

Results posted to the registry on 6 Jun 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Oral Contraceptive - 1	21	11
Flutamide - 2	24	13
Placebo - 3	22	13

Primary outcome: Change in Low-density Lipoprotein (LDL) Levels Over the Study Period

Time frame: 6 months. Mean (Standard Deviation). Unit: mg/dL

Measure	Oral Contraceptive - 1 n = 11	Flutamide - 2 n = 13	Placebo - 3 n = 13
Value	-6 (17)	-9 (14)	-7 (17)

Primary outcome: Change in High-density Lipoprotein (HDL) Levels During Study Period

Time frame: 6 months. Mean (Standard Deviation). Unit: mg/dL

Measure	Oral Contraceptive - 1 n = 11	Flutamide - 2 n = 13	Placebo - 3 n = 13
Value	6 (4)	-5 (7)	-2 (5)

Primary outcome: Change in Visceral Adipose Tissue (VAT) Volume as Measured by MRI

Time frame: 6 months. Mean (Standard Deviation). Unit: L

Measure	Oral Contraceptive - 1 n = 11	Flutamide - 2 n = 13	Placebo - 3 n = 13
Value	-0.1 (0.3)	-0.1 (0.6)	0.1 (0.6)

Primary outcome: Change in Fat Percentage as Measured by Dual-energy X-ray Absorptiometry (DEXA) Scan Over the Study Period

Time frame: 6 months. Mean (Standard Deviation). Unit: percentage of body mass

Measure	Oral Contraceptive - 1 n = 11	Flutamide - 2 n = 13	Placebo - 3 n = 13
Value	0.4 (1.5)	-1.9 (3.9)	-1.9 (2.3)

Adverse events

Time frame: 6 months - adverse event data collected over the study period.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Oral Contraceptive - 1	0 of 21 (0%)	1 of 21 (4.8%)	Not reported
Flutamide - 2	0 of 24 (0%)	4 of 24 (16.7%)	Not reported
Placebo - 3	0 of 22 (0%)	0 of 22 (0%)	Not reported

Limitations and caveats (from the sponsor): Please note there were 2 additional arms at the start of the study: Metformin alone (n=8) and Metformin+Flutamide (n=6), which were discontinued. These arms are therefore not included in these results data.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 9709934Diamanti-Kandarakis E, Mitrakou A, Raptis S, Tolis G, Duleba AJ. The effect of a pure antiandrogen receptor blocker, flutamide, on the lipid profile in the polycystic ovary syndrome. J Clin Endocrinol Metab. 1998 Aug;83(8):2699-705. doi: 10.1210/jcem.83.8.5041.
Background: PubMed 16868063Gambineri A, Patton L, Vaccina A, Cacciari M, Morselli-Labate AM, Cavazza C, Pagotto U, Pasquali R. Treatment with flutamide, metformin, and their combination added to a hypocaloric diet in overweight-obese women with polycystic ovary syndrome: a randomized, 12-month, placebo-controlled study. J Clin Endocrinol Metab. 2006 Oct;91(10):3970-80. doi: 10.1210/jc.2005-2250. Epub 2006 Jul 25.
Background: PubMed 14725687Gambineri A, Pelusi C, Genghini S, Morselli-Labate AM, Cacciari M, Pagotto U, Pasquali R. Effect of flutamide and metformin administered alone or in combination in dieting obese women with polycystic ovary syndrome. Clin Endocrinol (Oxf). 2004 Feb;60(2):241-9. doi: 10.1111/j.1365-2265.2004.01973.x.
Background: PubMed 17785364Urbanek M, Sam S, Legro RS, Dunaif A. Identification of a polycystic ovary syndrome susceptibility variant in fibrillin-3 and association with a metabolic phenotype. J Clin Endocrinol Metab. 2007 Nov;92(11):4191-8. doi: 10.1210/jc.2007-0761. Epub 2007 Sep 4.

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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Recruiting
The Effects of the Mediterranean Diet and Synbiotics in Polycystic Ovary Syndrome
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Recruiting
Brown Adipose Tissue Modulation in Polycystic Ovary Syndrome Using Infrared Thermography
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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.

Andrea Dunaif, MD principal investigator

Northwestern University

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

Questions about this trial

What is this clinical trial studying?

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 5 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 6 Jun 2014. 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. Some participants in this study may receive a placebo. 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?

Yes. Results are posted in the registry (first posted 6 Jun 2014). 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?

Change in Low-density Lipoprotein (LDL) Levels Over the Study Period (time frame: 6 months). The study lists 7 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 NCT00442689, which also lists 4 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 6 Jun 2014.