Trial Outcomes & Findings for Low Dose OC Therapy in Women With Polycystic Ovary Syndrome (PCOS): Impact of BMI on Hyperandrogenism (NCT NCT01360996)
NCT ID: NCT01360996
Last Updated: 2017-03-31
Results Overview
The primary outcome measure is post-treatment Free Androgen Index(FAI) which is expressed in units. FAI is calculated by taking the testosterone concentration (in nmol/l) and dividing by concentration of sex hormone binding globulin (SHBG in nmol/L)and multiplying by 100
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
64 participants
Primary outcome timeframe
24 weeks
Results posted on
2017-03-31
Participant Flow
This clinical trial was conducted from January 2012 to December 2014 Healthy, premenopausal women (n=64) with polycystic ovary syndrome (PCOS), aged between 16 and 35 years inclusive with a baseline body mass index (BMI) of \>18 to \<35kg/ m2, recruited from Woman's Metabolic Health clinic and Woman's Hospital gynecology clinics were enrolled
Diabetic subjects, smokers, injectable hormonal contraceptive use within 6 months, or those taking sex hormones, carbohydrate metabolism, lipid-lowering and/or anti-obesity drugs within 3 months of the study were excluded
Participant milestones
| Measure |
3 mg DRSP/20 μg EE--normal Weight
Folate-boosted 3 mg DRSP/20 μg EE-24/4 oral contraceptive
Normal weight -BMI 18-24.9 kg/ m2
3 mg DRSP/20 μg EE: 1 pill daily-24 days of drospirenone 3 mg (3 mg DRSP)/ethinyl estradiol 20 μg (20 μg EE)/levomefolate calcium 0.451 mg (folate) -followed by 4 days of levomefolate calcium 0.451 mg (folate)only
|
3 mg DRSP/20 μg EE- Overweight
Folate-boosted 3 mg DRSP/20 μg EE-24/4 oral contraceptive
BMI 25-29.9 kg/ m2
3 mg DRSP/20 μg EE: 1 pill daily-24 days of drospirenone 3 mg (3 mg DRSP)/ethinyl estradiol 20 μg (20 μg EE)/levomefolate calcium 0.451 mg (folate) -followed by 4 days of levomefolate calcium 0.451 mg (folate)only
|
3 mg DRSP/20 μg EE- Grade 1 Obese
Folate-boosted 3 mg DRSP/20 μg EE-24/4 oral contraceptive
BMI 30-34.9 kg/ m2
3 mg DRSP/20 μg EE: 1 pill daily-24 days of drospirenone 3 mg (3 mg DRSP)/ethinyl estradiol 20 μg (20 μg EE)/levomefolate calcium 0.451 mg (folate) -followed by 4 days of levomefolate calcium 0.451 mg (folate)only
|
|---|---|---|---|
|
Overall Study
STARTED
|
20
|
21
|
23
|
|
Overall Study
COMPLETED
|
14
|
18
|
21
|
|
Overall Study
NOT COMPLETED
|
6
|
3
|
2
|
Reasons for withdrawal
| Measure |
3 mg DRSP/20 μg EE--normal Weight
Folate-boosted 3 mg DRSP/20 μg EE-24/4 oral contraceptive
Normal weight -BMI 18-24.9 kg/ m2
3 mg DRSP/20 μg EE: 1 pill daily-24 days of drospirenone 3 mg (3 mg DRSP)/ethinyl estradiol 20 μg (20 μg EE)/levomefolate calcium 0.451 mg (folate) -followed by 4 days of levomefolate calcium 0.451 mg (folate)only
|
3 mg DRSP/20 μg EE- Overweight
Folate-boosted 3 mg DRSP/20 μg EE-24/4 oral contraceptive
BMI 25-29.9 kg/ m2
3 mg DRSP/20 μg EE: 1 pill daily-24 days of drospirenone 3 mg (3 mg DRSP)/ethinyl estradiol 20 μg (20 μg EE)/levomefolate calcium 0.451 mg (folate) -followed by 4 days of levomefolate calcium 0.451 mg (folate)only
|
3 mg DRSP/20 μg EE- Grade 1 Obese
Folate-boosted 3 mg DRSP/20 μg EE-24/4 oral contraceptive
BMI 30-34.9 kg/ m2
3 mg DRSP/20 μg EE: 1 pill daily-24 days of drospirenone 3 mg (3 mg DRSP)/ethinyl estradiol 20 μg (20 μg EE)/levomefolate calcium 0.451 mg (folate) -followed by 4 days of levomefolate calcium 0.451 mg (folate)only
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
4
|
3
|
2
|
|
Overall Study
Noncompliant
|
2
|
0
|
0
|
Baseline Characteristics
Low Dose OC Therapy in Women With Polycystic Ovary Syndrome (PCOS): Impact of BMI on Hyperandrogenism
Baseline characteristics by cohort
| Measure |
3 mg DRSP/20 μg EE--normal Weight
n=20 Participants
Folate-boosted 3 mg DRSP/20 μg EE-24/4 oral contraceptive
Normal weight -BMI 18-24.9 kg/ m2
3 mg DRSP/20 μg EE: 1 pill daily-24 days of drospirenone 3 mg (3 mg DRSP)/ethinyl estradiol 20 μg (20 μg EE)/levomefolate calcium 0.451 mg (folate) -followed by 4 days of levomefolate calcium 0.451 mg (folate)only
|
3 mg DRSP/20 μg EE- Overweight
n=21 Participants
Folate-boosted 3 mg DRSP/20 μg EE-24/4 oral contraceptive
BMI 25-29.9 kg/ m2
3 mg DRSP/20 μg EE: 1 pill daily-24 days of drospirenone 3 mg (3 mg DRSP)/ethinyl estradiol 20 μg (20 μg EE)/levomefolate calcium 0.451 mg (folate) -followed by 4 days of levomefolate calcium 0.451 mg (folate)only
|
3 mg DRSP/20 μg EE- Grade 1 Obese
n=23 Participants
Folate-boosted 3 mg DRSP/20 μg EE-24/4 oral contraceptive
BMI 30-34.9 kg/ m2
3 mg DRSP/20 μg EE: 1 pill daily-24 days of drospirenone 3 mg (3 mg DRSP)/ethinyl estradiol 20 μg (20 μg EE)/levomefolate calcium 0.451 mg (folate) -followed by 4 days of levomefolate calcium 0.451 mg (folate)only
|
Total
n=64 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
3 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
9 Participants
n=483 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
17 Participants
n=93 Participants
|
19 Participants
n=4 Participants
|
19 Participants
n=27 Participants
|
55 Participants
n=483 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=93 Participants
|
21 Participants
n=4 Participants
|
23 Participants
n=27 Participants
|
64 Participants
n=483 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=93 Participants
|
21 participants
n=4 Participants
|
23 participants
n=27 Participants
|
64 participants
n=483 Participants
|
PRIMARY outcome
Timeframe: 24 weeksThe primary outcome measure is post-treatment Free Androgen Index(FAI) which is expressed in units. FAI is calculated by taking the testosterone concentration (in nmol/l) and dividing by concentration of sex hormone binding globulin (SHBG in nmol/L)and multiplying by 100
Outcome measures
| Measure |
Non-Obese
n=32 Participants
There was no significant difference on any variables between normal and overweight at baseline so groups were combined into non-obese
Folate-boosted 3 mg DRSP/20 ug EE-24/4 oral contraceptive
BMI 18-29.9 kg/m2
|
Obese
n=21 Participants
Folate-boosted 3 mg DRSP/20 ug EE-24/4 oral contraceptive
BMI 30-34.9 kg/m2 (obese grade 10
|
|---|---|---|
|
Biochemical Assessment of Hyperandrogenism
|
0.7 Index
Standard Deviation 0.5
|
0.7 Index
Standard Deviation 0.45
|
SECONDARY outcome
Timeframe: 24 weeksValues represent blood pressure at 24 weeks.
Outcome measures
| Measure |
Non-Obese
n=32 Participants
There was no significant difference on any variables between normal and overweight at baseline so groups were combined into non-obese
Folate-boosted 3 mg DRSP/20 ug EE-24/4 oral contraceptive
BMI 18-29.9 kg/m2
|
Obese
n=21 Participants
Folate-boosted 3 mg DRSP/20 ug EE-24/4 oral contraceptive
BMI 30-34.9 kg/m2 (obese grade 10
|
|---|---|---|
|
Cardiometabolic Measures
|
120 mmHg
Standard Deviation 13
|
125 mmHg
Standard Deviation 9
|
SECONDARY outcome
Timeframe: 24 weeksPost-treatment body mass index at 24 weeks
Outcome measures
| Measure |
Non-Obese
n=32 Participants
There was no significant difference on any variables between normal and overweight at baseline so groups were combined into non-obese
Folate-boosted 3 mg DRSP/20 ug EE-24/4 oral contraceptive
BMI 18-29.9 kg/m2
|
Obese
n=21 Participants
Folate-boosted 3 mg DRSP/20 ug EE-24/4 oral contraceptive
BMI 30-34.9 kg/m2 (obese grade 10
|
|---|---|---|
|
Post Therapy BMI.
|
24.6 kg/m2
Standard Deviation 3.9
|
32.7 kg/m2
Standard Deviation 2.7
|
SECONDARY outcome
Timeframe: 24 weeksPost-treatment in folate concentrations after 24 weeks of treatment
Outcome measures
| Measure |
Non-Obese
n=32 Participants
There was no significant difference on any variables between normal and overweight at baseline so groups were combined into non-obese
Folate-boosted 3 mg DRSP/20 ug EE-24/4 oral contraceptive
BMI 18-29.9 kg/m2
|
Obese
n=21 Participants
Folate-boosted 3 mg DRSP/20 ug EE-24/4 oral contraceptive
BMI 30-34.9 kg/m2 (obese grade 10
|
|---|---|---|
|
Biochemical Indicator of B-vitamin Status
|
65.8 Folate in nmol/l
Standard Deviation 20.4
|
60.8 Folate in nmol/l
Standard Deviation 20.6
|
SECONDARY outcome
Timeframe: 24 weeksPost treatment menstrual frequency over 24 weeks normalized to number of menses per year ..
Outcome measures
| Measure |
Non-Obese
n=32 Participants
There was no significant difference on any variables between normal and overweight at baseline so groups were combined into non-obese
Folate-boosted 3 mg DRSP/20 ug EE-24/4 oral contraceptive
BMI 18-29.9 kg/m2
|
Obese
n=21 Participants
Folate-boosted 3 mg DRSP/20 ug EE-24/4 oral contraceptive
BMI 30-34.9 kg/m2 (obese grade 10
|
|---|---|---|
|
Menstrual Cycle Regularity
|
11.3 number of cycles annually
Standard Deviation 1.7
|
11 number of cycles annually
Standard Deviation 1.4
|
SECONDARY outcome
Timeframe: 24 weeksPost-treatment levels of adrenal androgen DHEAS
Outcome measures
| Measure |
Non-Obese
n=32 Participants
There was no significant difference on any variables between normal and overweight at baseline so groups were combined into non-obese
Folate-boosted 3 mg DRSP/20 ug EE-24/4 oral contraceptive
BMI 18-29.9 kg/m2
|
Obese
n=21 Participants
Folate-boosted 3 mg DRSP/20 ug EE-24/4 oral contraceptive
BMI 30-34.9 kg/m2 (obese grade 10
|
|---|---|---|
|
Adrenal Androgen DHEAS
|
4.9 micromol/L
Standard Deviation 2.2
|
4.3 micromol/L
Standard Deviation 2.3
|
SECONDARY outcome
Timeframe: 24 weeksPost-treatment insulin secretion-sensitivity index (ISSI) calculated from the oral glucose tolerance test (OGTT). A higher value indicate improved carbohydrate metabolism
Outcome measures
| Measure |
Non-Obese
n=32 Participants
There was no significant difference on any variables between normal and overweight at baseline so groups were combined into non-obese
Folate-boosted 3 mg DRSP/20 ug EE-24/4 oral contraceptive
BMI 18-29.9 kg/m2
|
Obese
n=21 Participants
Folate-boosted 3 mg DRSP/20 ug EE-24/4 oral contraceptive
BMI 30-34.9 kg/m2 (obese grade 10
|
|---|---|---|
|
Oral Disposition Index
|
732 calculated index
Standard Deviation 420
|
272 calculated index
Standard Deviation 226
|
Adverse Events
3 mg DRSP/20 μg EE--normal Weight
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
3 mg DRSP/20 μg EE- Overweight
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
3 mg DRSP/20 μg EE- Grade 1 Obese
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place