Trial Outcomes & Findings for Metabolic Syndrome in PCOS: Precursors and Interventions (NCT NCT00442689)

Results Overview

Change in low-density lipoprotein (LDL) levels over the study period (LDL level at study endpoint - baseline LDL level)

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

97 participants

Primary outcome timeframe

6 months

Results posted on

2014-06-06

Participant Flow

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

Participant milestones

Participant milestones
Measure	Oral Contraceptive - 1 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 - 2 Flutamide Flutamide: 250 mg twice daily	Placebo - 3 Placebo only
Overall Study STARTED	21	24	22
Overall Study COMPLETED	11	13	13
Overall Study NOT COMPLETED	10	11	9

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Metabolic Syndrome in PCOS: Precursors and Interventions

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Oral Contraceptive - 1 n=21 Participants Oral contraceptive (containing 35mcg of ethinyl estradiol and 3mg of drospirenone)	Flutamide - 2 n=24 Participants Flutamide Flutamide: 250 mg twice daily	Placebo - 3 n=22 Participants Placebo	Total n=67 Participants Total of all reporting groups
Age, Continuous	28 years STANDARD_DEVIATION 4 • n=5 Participants	28 years STANDARD_DEVIATION 4 • n=7 Participants	28 years STANDARD_DEVIATION 5 • n=5 Participants	28 years STANDARD_DEVIATION 4 • n=4 Participants
Sex: Female, Male Female	21 Participants n=5 Participants	24 Participants n=7 Participants	22 Participants n=5 Participants	67 Participants n=4 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Body mass index (kg/m^2)	37.1 kg/m^2 STANDARD_DEVIATION 5.5 • n=5 Participants	40.1 kg/m^2 STANDARD_DEVIATION 5.6 • n=7 Participants	40.0 kg/m^2 STANDARD_DEVIATION 6.7 • n=5 Participants	39.3 kg/m^2 STANDARD_DEVIATION 6.0 • n=4 Participants

PRIMARY outcome

Timeframe: 6 months

Change in low-density lipoprotein (LDL) levels over the study period (LDL level at study endpoint - baseline LDL level)

Outcome measures

Outcome measures
Measure	Oral Contraceptive - 1 n=11 Participants Oral contraceptive (containing 35mcg of ethinyl estradiol and 3mg of drospirenone)	Flutamide - 2 n=13 Participants Flutamide Flutamide: 250 mg twice daily	Placebo - 3 n=13 Participants Placebo
Change in Low-density Lipoprotein (LDL) Levels Over the Study Period	-6 mg/dL Standard Deviation 17	-9 mg/dL Standard Deviation 14	-7 mg/dL Standard Deviation 17

PRIMARY outcome

Timeframe: 6 months

Change in high-density lipoprotein (HDL) levels during study period (HDL level at study endpoint - baseline HDL)

Outcome measures

Outcome measures
Measure	Oral Contraceptive - 1 n=11 Participants Oral contraceptive (containing 35mcg of ethinyl estradiol and 3mg of drospirenone)	Flutamide - 2 n=13 Participants Flutamide Flutamide: 250 mg twice daily	Placebo - 3 n=13 Participants Placebo
Change in High-density Lipoprotein (HDL) Levels During Study Period	6 mg/dL Standard Deviation 4	-5 mg/dL Standard Deviation 7	-2 mg/dL Standard Deviation 5

PRIMARY outcome

Timeframe: 6 months

Change in visceral adipose tissue (VAT) volume as measured by MRI (VAT at study endpoint - baseline VAT)

Outcome measures

Outcome measures
Measure	Oral Contraceptive - 1 n=11 Participants Oral contraceptive (containing 35mcg of ethinyl estradiol and 3mg of drospirenone)	Flutamide - 2 n=13 Participants Flutamide Flutamide: 250 mg twice daily	Placebo - 3 n=13 Participants Placebo
Change in Visceral Adipose Tissue (VAT) Volume as Measured by MRI	-0.1 L Standard Deviation 0.3	-0.1 L Standard Deviation 0.6	0.1 L Standard Deviation 0.6

PRIMARY outcome

Timeframe: 6 months

Change in fat percentage as measured by DEXA scan over the study period (Fat percentage at study endpoint - baseline fat percentage)

Outcome measures

Outcome measures
Measure	Oral Contraceptive - 1 n=11 Participants Oral contraceptive (containing 35mcg of ethinyl estradiol and 3mg of drospirenone)	Flutamide - 2 n=13 Participants Flutamide Flutamide: 250 mg twice daily	Placebo - 3 n=13 Participants Placebo
Change in Fat Percentage as Measured by Dual-energy X-ray Absorptiometry (DEXA) Scan Over the Study Period	0.4 percentage of body mass Standard Deviation 1.5	-1.9 percentage of body mass Standard Deviation 3.9	-1.9 percentage of body mass Standard Deviation 2.3

PRIMARY outcome

Timeframe: 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)

Outcome measures

Outcome measures
Measure	Oral Contraceptive - 1 n=11 Participants Oral contraceptive (containing 35mcg of ethinyl estradiol and 3mg of drospirenone)	Flutamide - 2 n=13 Participants Flutamide Flutamide: 250 mg twice daily	Placebo - 3 n=13 Participants Placebo
Change in Disposition Index	1653 min^-1 Standard Deviation 6008	194 min^-1 Standard Deviation 1424	-184 min^-1 Standard Deviation 825

PRIMARY outcome

Timeframe: 6 months

Change in resting energy expenditure (REE) over the study period (REE at study endpoint - baseline REE)

Outcome measures

Outcome measures
Measure	Oral Contraceptive - 1 n=11 Participants Oral contraceptive (containing 35mcg of ethinyl estradiol and 3mg of drospirenone)	Flutamide - 2 n=13 Participants Flutamide Flutamide: 250 mg twice daily	Placebo - 3 n=13 Participants Placebo
Change in Resting Energy Expenditure (REE) Over the Study Period	7 Kcal/day Standard Deviation 209	-79 Kcal/day Standard Deviation 239	-88 Kcal/day Standard Deviation 203

PRIMARY outcome

Timeframe: 6 months

Change in maximal aerobic exercise capacity (VO2 max) over the study period (VO2 max at study endpoint - baseline VO2 max)

Outcome measures

Outcome measures
Measure	Oral Contraceptive - 1 n=11 Participants Oral contraceptive (containing 35mcg of ethinyl estradiol and 3mg of drospirenone)	Flutamide - 2 n=13 Participants Flutamide Flutamide: 250 mg twice daily	Placebo - 3 n=13 Participants Placebo
Change in Maximal Aerobic Exercise Capacity (VO2 Max) Over the Study Period	-0.5 L/min Standard Deviation 6.5	-1.6 L/min Standard Deviation 4.4	1.1 L/min Standard Deviation 4.9

Adverse Events

Oral Contraceptive - 1

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Flutamide - 2

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Placebo - 3

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Oral Contraceptive - 1 n=21 participants at risk 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 - 2 n=24 participants at risk Flutamide Flutamide: 250 mg twice daily	Placebo - 3 n=22 participants at risk Placebo only
Hepatobiliary disorders Abnormal LFTs	4.8% 1/21 • Number of events 1 • 6 months - adverse event data collected over the study period.	16.7% 4/24 • Number of events 4 • 6 months - adverse event data collected over the study period.	0.00% 0/22 • 6 months - adverse event data collected over the study period.

Additional Information

Dr. Laura Torchen

Northwestern University

Phone: 312-227-6492

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place