Trial · NCT00442689
Metabolic Syndrome in PCOS: Precursors and Interventions
NCT00442689, Not applicable, Completed, Northwestern University; results first posted 2014-06-06
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Metabolic Syndrome in PCOS: Precursors and Interventions. Trials, record NCT00442689. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00442689
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Metabolic Syndrome in PCOS: Precursors and Interventions
- NCT number
- NCT00442689
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 97 participants, actual
- Lead sponsor
- Northwestern University
- Conditions
- Polycystic Ovary Syndrome, Metabolic Syndrome
- Interventions
- flutamide, ethinyl estradiol 35 mcg and drospirenone 3 mg, placebo
- First posted
- 2007-03-02
- Last updated
- 2014-06-06
- Results first posted
- 2014-06-06
- Limitations and caveats
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.
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Low-density Lipoprotein (LDL) Levels Over the Study Period | 6 months | Change in low-density lipoprotein (LDL) levels over the study period (LDL level at study endpoint - baseline LDL level) |
| Primary | Change in High-density Lipoprotein (HDL) Levels During Study Period | 6 months | Change in high-density lipoprotein (HDL) levels during study period (HDL level at study endpoint - baseline HDL) |
| Primary | Change in Visceral Adipose Tissue (VAT) Volume as Measured by MRI | 6 months | Change in visceral adipose tissue (VAT) volume as measured by MRI (VAT at study endpoint - baseline VAT) |
| Primary | Change in Fat Percentage as Measured by Dual-energy X-ray Absorptiometry (DEXA) Scan Over the Study Period | 6 months | Change in fat percentage as measured by DEXA scan over the study period (Fat percentage at study endpoint - baseline fat percentage) |
| Primary | Change in Disposition Index | 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) |
| Primary | Change in Resting Energy Expenditure (REE) Over the Study Period | 6 months | Change in resting energy expenditure (REE) over the study period (REE at study endpoint - baseline REE) |
| Primary | Change in Maximal Aerobic Exercise Capacity (VO2 Max) Over the Study Period | 6 months | Change in maximal aerobic exercise capacity (VO2 max) over the study period (VO2 max at study endpoint - baseline VO2 max) |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Low-density Lipoprotein (LDL) Levels Over the Study Period | 6 months | mg/dL | MEAN | |
| PRIMARY | Change in High-density Lipoprotein (HDL) Levels During Study Period | 6 months | mg/dL | MEAN | |
| PRIMARY | Change in Visceral Adipose Tissue (VAT) Volume as Measured by MRI | 6 months | L | MEAN | |
| PRIMARY | Change in Fat Percentage as Measured by Dual-energy X-ray Absorptiometry (DEXA) Scan Over the Study Period | 6 months | percentage of body mass | MEAN | |
| PRIMARY | Change in Disposition Index | 6 months | min^-1 | MEAN | |
| PRIMARY | Change in Resting Energy Expenditure (REE) Over the Study Period | 6 months | Kcal/day | MEAN | |
| PRIMARY | Change in Maximal Aerobic Exercise Capacity (VO2 Max) Over the Study Period | 6 months | L/min | MEAN |
Source ClinicalTrials.gov
Results by group21
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Low-density Lipoprotein (LDL) Levels Over the Study Period | Oral Contraceptive - 1 | -6 | Standard Deviation 17 | mg/dL | |
| Change in Low-density Lipoprotein (LDL) Levels Over the Study Period | Flutamide - 2 | -9 | Standard Deviation 14 | mg/dL | |
| Change in Low-density Lipoprotein (LDL) Levels Over the Study Period | Placebo - 3 | -7 | Standard Deviation 17 | mg/dL | |
| Change in High-density Lipoprotein (HDL) Levels During Study Period | Oral Contraceptive - 1 | 6 | Standard Deviation 4 | mg/dL | |
| Change in High-density Lipoprotein (HDL) Levels During Study Period | Flutamide - 2 | -5 | Standard Deviation 7 | mg/dL | |
| Change in High-density Lipoprotein (HDL) Levels During Study Period | Placebo - 3 | -2 | Standard Deviation 5 | mg/dL | |
| Change in Visceral Adipose Tissue (VAT) Volume as Measured by MRI | Oral Contraceptive - 1 | -0.1 | Standard Deviation 0.3 | L | |
| Change in Visceral Adipose Tissue (VAT) Volume as Measured by MRI | Flutamide - 2 | -0.1 | Standard Deviation 0.6 | L | |
| Change in Visceral Adipose Tissue (VAT) Volume as Measured by MRI | Placebo - 3 | 0.1 | Standard Deviation 0.6 | L | |
| Change in Fat Percentage as Measured by Dual-energy X-ray Absorptiometry (DEXA) Scan Over the Study Period | Oral Contraceptive - 1 | 0.4 | Standard Deviation 1.5 | percentage of body mass |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Oral Contraceptive - 1 | 21 | |
| Overall Study | STARTED | Flutamide - 2 | 24 | |
| Overall Study | STARTED | Placebo - 3 | 22 | |
| Overall Study | COMPLETED | Oral Contraceptive - 1 | 11 | |
| Overall Study | COMPLETED | Flutamide - 2 | 13 | |
| Overall Study | COMPLETED | Placebo - 3 | 13 | |
| Overall Study | NOT COMPLETED | Oral Contraceptive - 1 | 10 | |
| Overall Study | NOT COMPLETED | Flutamide - 2 | 11 | |
| Overall Study | NOT COMPLETED | Placebo - 3 | 9 |
Source ClinicalTrials.gov
Adverse events3
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Abnormal LFTs | Hepatobiliary disorders | Oral Contraceptive - 1 | 1 | 21 | 1 |
| other | Abnormal LFTs | Hepatobiliary disorders | Flutamide - 2 | 4 | 24 | 4 |
| other | Abnormal LFTs | Hepatobiliary disorders | Placebo - 3 | 0 | 22 | 0 |
Source ClinicalTrials.gov
Adverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Oral Contraceptive - 1 | ||
| Total, all-cause mortality | Flutamide - 2 | ||
| Total, all-cause mortality | Placebo - 3 | ||
| Total, other adverse events | Oral Contraceptive - 1 | 1 | 21 |
| Total, other adverse events | Flutamide - 2 | 4 | 24 |
| Total, other adverse events | Placebo - 3 | 0 | 22 |
| Total, serious adverse events | Oral Contraceptive - 1 | 0 | 21 |
| Total, serious adverse events | Flutamide - 2 | 0 | 24 |
| Total, serious adverse events | Placebo - 3 | 0 | 22 |
Source ClinicalTrials.gov
Papers4
The papers the trial lists on ClinicalTrials.gov.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| R01DK073411 | Metabolic Syndrome in PCOS: Precursors and Interventions | DUNAIF, ANDREA E | NORTHWESTERN UNIVERSITY AT CHICAGO | NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES | 2006 to 2010 |
Source NIH RePORTER
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00442689
GET https://conductscience.org/api/trials/v1/NCT00442689/results?page=2