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Trial record 73 of 100 for:    DROSPIRENONE AND ETHINYL ESTRADIOL AND ethinylestradiol

Metabolic Syndrome in PCOS: Precursors and Interventions

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ClinicalTrials.gov Identifier: NCT00442689
Recruitment Status : Completed
First Posted : March 2, 2007
Results First Posted : June 6, 2014
Last Update Posted : June 6, 2014
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Andrea Dunaif, Northwestern University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Conditions Polycystic Ovary Syndrome
Metabolic Syndrome
Interventions Drug: flutamide
Drug: ethinyl estradiol 35 mcg and drospirenone 3 mg
Other: placebo
Enrollment 97
Recruitment Details  
Pre-assignment Details 97 total subjects enrolled. Prior to randomization, 16 subjects were excluded or dropped out, leaving 81 active subjects. Early in the study, 2 of the 5 study arms were discontinued: participants receiving Metformin only (8 subjects) and those receiving Metformin + Flutamide (6 subjects) - leaving 67 subjects whose data were analyzed
Arm/Group Title Oral Contraceptive - 1 Flutamide - 2 Placebo - 3
Hide Arm/Group Description

Oral contraceptive (containing 35mcg of ethinyl estradiol and 3mg of drospirenone)

Oral contraceptive: one active pill per day for three weeks and then 1 sugar pill per day for one week

Flutamide

Flutamide: 250 mg twice daily

Placebo only
Period Title: Overall Study
Started 21 24 22
Completed 11 13 13
Not Completed 10 11 9
Arm/Group Title Oral Contraceptive - 1 Flutamide - 2 Placebo - 3 Total
Hide Arm/Group Description Oral contraceptive (containing 35mcg of ethinyl estradiol and 3mg of drospirenone)

Flutamide

Flutamide: 250 mg twice daily

Placebo Total of all reporting groups
Overall Number of Baseline Participants 21 24 22 67
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 21 participants 24 participants 22 participants 67 participants
28  (4) 28  (4) 28  (5) 28  (4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 21 participants 24 participants 22 participants 67 participants
Female
21
 100.0%
24
 100.0%
22
 100.0%
67
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Body mass index (kg/m^2)  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 21 participants 24 participants 22 participants 67 participants
37.1  (5.5) 40.1  (5.6) 40.0  (6.7) 39.3  (6.0)
1.Primary Outcome
Title Change in Low-density Lipoprotein (LDL) Levels Over the Study Period
Hide Description Change in low-density lipoprotein (LDL) levels over the study period (LDL level at study endpoint - baseline LDL level)
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Oral Contraceptive - 1 Flutamide - 2 Placebo - 3
Hide Arm/Group Description:
Oral contraceptive (containing 35mcg of ethinyl estradiol and 3mg of drospirenone)

Flutamide

Flutamide: 250 mg twice daily

Placebo
Overall Number of Participants Analyzed 11 13 13
Mean (Standard Deviation)
Unit of Measure: mg/dL
-6  (17) -9  (14) -7  (17)
2.Primary Outcome
Title Change in High-density Lipoprotein (HDL) Levels During Study Period
Hide Description Change in high-density lipoprotein (HDL) levels during study period (HDL level at study endpoint - baseline HDL)
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Oral Contraceptive - 1 Flutamide - 2 Placebo - 3
Hide Arm/Group Description:
Oral contraceptive (containing 35mcg of ethinyl estradiol and 3mg of drospirenone)

Flutamide

Flutamide: 250 mg twice daily

Placebo
Overall Number of Participants Analyzed 11 13 13
Mean (Standard Deviation)
Unit of Measure: mg/dL
6  (4) -5  (7) -2  (5)
3.Primary Outcome
Title Change in Visceral Adipose Tissue (VAT) Volume as Measured by MRI
Hide Description Change in visceral adipose tissue (VAT) volume as measured by MRI (VAT at study endpoint - baseline VAT)
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Oral Contraceptive - 1 Flutamide - 2 Placebo - 3
Hide Arm/Group Description:
Oral contraceptive (containing 35mcg of ethinyl estradiol and 3mg of drospirenone)

Flutamide

Flutamide: 250 mg twice daily

Placebo
Overall Number of Participants Analyzed 11 13 13
Mean (Standard Deviation)
Unit of Measure: L
-0.1  (0.3) -0.1  (0.6) 0.1  (0.6)
4.Primary Outcome
Title Change in Fat Percentage as Measured by Dual-energy X-ray Absorptiometry (DEXA) Scan Over the Study Period
Hide Description Change in fat percentage as measured by DEXA scan over the study period (Fat percentage at study endpoint - baseline fat percentage)
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Oral Contraceptive - 1 Flutamide - 2 Placebo - 3
Hide Arm/Group Description:
Oral contraceptive (containing 35mcg of ethinyl estradiol and 3mg of drospirenone)

Flutamide

Flutamide: 250 mg twice daily

Placebo
Overall Number of Participants Analyzed 11 13 13
Mean (Standard Deviation)
Unit of Measure: percentage of body mass
0.4  (1.5) -1.9  (3.9) -1.9  (2.3)
5.Primary Outcome
Title Change in Disposition Index
Hide Description 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)
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Oral Contraceptive - 1 Flutamide - 2 Placebo - 3
Hide Arm/Group Description:
Oral contraceptive (containing 35mcg of ethinyl estradiol and 3mg of drospirenone)

Flutamide

Flutamide: 250 mg twice daily

Placebo
Overall Number of Participants Analyzed 11 13 13
Mean (Standard Deviation)
Unit of Measure: min^-1
1653  (6008) 194  (1424) -184  (825)
6.Primary Outcome
Title Change in Resting Energy Expenditure (REE) Over the Study Period
Hide Description Change in resting energy expenditure (REE) over the study period (REE at study endpoint - baseline REE)
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Oral Contraceptive - 1 Flutamide - 2 Placebo - 3
Hide Arm/Group Description:
Oral contraceptive (containing 35mcg of ethinyl estradiol and 3mg of drospirenone)

Flutamide

Flutamide: 250 mg twice daily

Placebo
Overall Number of Participants Analyzed 11 13 13
Mean (Standard Deviation)
Unit of Measure: Kcal/day
7  (209) -79  (239) -88  (203)
7.Primary Outcome
Title Change in Maximal Aerobic Exercise Capacity (VO2 Max) Over the Study Period
Hide Description Change in maximal aerobic exercise capacity (VO2 max) over the study period (VO2 max at study endpoint - baseline VO2 max)
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Oral Contraceptive - 1 Flutamide - 2 Placebo - 3
Hide Arm/Group Description:
Oral contraceptive (containing 35mcg of ethinyl estradiol and 3mg of drospirenone)

Flutamide

Flutamide: 250 mg twice daily

Placebo
Overall Number of Participants Analyzed 11 13 13
Mean (Standard Deviation)
Unit of Measure: L/min
-0.5  (6.5) -1.6  (4.4) 1.1  (4.9)
Time Frame 6 months - adverse event data collected over the study period.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Oral Contraceptive - 1 Flutamide - 2 Placebo - 3
Hide Arm/Group Description

Oral contraceptive (containing 35mcg of ethinyl estradiol and 3mg of drospirenone)

Oral contraceptive: one active pill per day for three weeks and then 1 sugar pill per day for one week

Flutamide

Flutamide: 250 mg twice daily

Placebo only
All-Cause Mortality
Oral Contraceptive - 1 Flutamide - 2 Placebo - 3
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Oral Contraceptive - 1 Flutamide - 2 Placebo - 3
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/21 (0.00%)      0/24 (0.00%)      0/22 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Oral Contraceptive - 1 Flutamide - 2 Placebo - 3
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/21 (4.76%)      4/24 (16.67%)      0/22 (0.00%)    
Hepatobiliary disorders       
Abnormal LFTs  1/21 (4.76%)  1 4/24 (16.67%)  4 0/22 (0.00%)  0
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.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Dr. Laura Torchen
Organization: Northwestern University
Phone: 312-227-6492
Responsible Party: Andrea Dunaif, Northwestern University
ClinicalTrials.gov Identifier: NCT00442689     History of Changes
Other Study ID Numbers: DK73411
R01DK073411 ( U.S. NIH Grant/Contract )
First Submitted: February 5, 2007
First Posted: March 2, 2007
Results First Submitted: April 9, 2014
Results First Posted: June 6, 2014
Last Update Posted: June 6, 2014