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Trial record 52 of 101 for:    DROSPIRENONE AND ETHINYL ESTRADIOL AND ethinylestradiol

Low Dose OC Therapy in Women With Polycystic Ovary Syndrome (PCOS): Impact of BMI on Hyperandrogenism (BEYAZ-PCOS)

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ClinicalTrials.gov Identifier: NCT01360996
Recruitment Status : Completed
First Posted : May 26, 2011
Results First Posted : March 31, 2017
Last Update Posted : March 31, 2017
Sponsor:
Collaborator:
Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma
Information provided by (Responsible Party):
Karen Elkind-Hirsch, Woman's

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Polycystic Ovary Syndrome
Intervention Drug: 3 mg DRSP/20 μg EE
Enrollment 64
Recruitment Details 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
Pre-assignment Details 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
Arm/Group Title 3 mg DRSP/20 μg EE--normal Weight 3 mg DRSP/20 μg EE- Overweight 3 mg DRSP/20 μg EE- Grade 1 Obese
Hide Arm/Group Description

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

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

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

Period Title: Overall Study
Started 20 21 23
Completed 14 18 21
Not Completed 6 3 2
Reason Not Completed
Withdrawal by Subject             4             3             2
Noncompliant             2             0             0
Arm/Group Title 3 mg DRSP/20 μg EE--normal Weight 3 mg DRSP/20 μg EE- Overweight 3 mg DRSP/20 μg EE- Grade 1 Obese Total
Hide Arm/Group Description

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

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

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 of all reporting groups
Overall Number of Baseline Participants 20 21 23 64
Hide Baseline Analysis Population Description
oligomenorrhea and biochemical hyperandrogenism (total T >1.38 nmol/l or free androgen index [FAI] >3.87) and exclusion of other etiologies (non-classic congenital adrenal hyperplasia, androgen-secreting tumors, hyperprolactinemia, Cushing syndrome, thyroid dysfunction and primary ovarian insufficiency
Age, Categorical   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 21 participants 23 participants 64 participants
<=18 years
3
  15.0%
2
   9.5%
4
  17.4%
9
  14.1%
Between 18 and 65 years
17
  85.0%
19
  90.5%
19
  82.6%
55
  85.9%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
[1]
Measure Description: Healthy, premenopausal women (n=64) with polycystic ovary syndrome (PCOS), aged between 16 and 35 years inclusive with a body mass index (BMI) of >18 to <35kg/ m2,
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 21 participants 23 participants 64 participants
Female
20
 100.0%
21
 100.0%
23
 100.0%
64
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 20 participants 21 participants 23 participants 64 participants
20 21 23 64
1.Primary Outcome
Title Biochemical Assessment of Hyperandrogenism
Hide Description

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

Time Frame 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Non-Obese Obese
Hide Arm/Group Description:

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

Folate-boosted 3 mg DRSP/20 ug EE-24/4 oral contraceptive

BMI 30-34.9 kg/m2 (obese grade 10

Overall Number of Participants Analyzed 32 21
Mean (Standard Deviation)
Unit of Measure: Index
0.7  (0.5) 0.7  (0.45)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Non-Obese, Obese
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.0001
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
2.Secondary Outcome
Title Cardiometabolic Measures
Hide Description Values represent blood pressure at 24 weeks.
Time Frame 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Non-Obese Obese
Hide Arm/Group Description:

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

Folate-boosted 3 mg DRSP/20 ug EE-24/4 oral contraceptive

BMI 30-34.9 kg/m2 (obese grade 10

Overall Number of Participants Analyzed 32 21
Mean (Standard Deviation)
Unit of Measure: mmHg
120  (13) 125  (9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Non-Obese, Obese
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.05
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
3.Secondary Outcome
Title Post Therapy BMI.
Hide Description Post-treatment body mass index at 24 weeks
Time Frame 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Non-Obese Obese
Hide Arm/Group Description:

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

Folate-boosted 3 mg DRSP/20 ug EE-24/4 oral contraceptive

BMI 30-34.9 kg/m2 (obese grade 10

Overall Number of Participants Analyzed 32 21
Mean (Standard Deviation)
Unit of Measure: kg/m2
24.6  (3.9) 32.7  (2.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Non-Obese, Obese
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.05
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
4.Secondary Outcome
Title Biochemical Indicator of B-vitamin Status
Hide Description Post-treatment in folate concentrations after 24 weeks of treatment
Time Frame 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Non-Obese Obese
Hide Arm/Group Description:

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

Folate-boosted 3 mg DRSP/20 ug EE-24/4 oral contraceptive

BMI 30-34.9 kg/m2 (obese grade 10

Overall Number of Participants Analyzed 32 21
Mean (Standard Deviation)
Unit of Measure: Folate in nmol/l
65.8  (20.4) 60.8  (20.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Non-Obese, Obese
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
5.Secondary Outcome
Title Menstrual Cycle Regularity
Hide Description Post treatment menstrual frequency over 24 weeks normalized to number of menses per year ..
Time Frame 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Non-Obese Obese
Hide Arm/Group Description:

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

Folate-boosted 3 mg DRSP/20 ug EE-24/4 oral contraceptive

BMI 30-34.9 kg/m2 (obese grade 10

Overall Number of Participants Analyzed 32 21
Mean (Standard Deviation)
Unit of Measure: number of cycles annually
11.3  (1.7) 11  (1.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Non-Obese, Obese
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method McNemar
Comments [Not Specified]
6.Secondary Outcome
Title Adrenal Androgen DHEAS
Hide Description Post-treatment levels of adrenal androgen DHEAS
Time Frame 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Non-Obese Obese
Hide Arm/Group Description:

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

Folate-boosted 3 mg DRSP/20 ug EE-24/4 oral contraceptive

BMI 30-34.9 kg/m2 (obese grade 10

Overall Number of Participants Analyzed 32 21
Mean (Standard Deviation)
Unit of Measure: micromol/L
4.9  (2.2) 4.3  (2.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Non-Obese, Obese
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
7.Secondary Outcome
Title Oral Disposition Index
Hide Description Post-treatment insulin secretion-sensitivity index (ISSI) calculated from the oral glucose tolerance test (OGTT). A higher value indicate improved carbohydrate metabolism
Time Frame 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Non-Obese Obese
Hide Arm/Group Description:

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

Folate-boosted 3 mg DRSP/20 ug EE-24/4 oral contraceptive

BMI 30-34.9 kg/m2 (obese grade 10

Overall Number of Participants Analyzed 32 21
Mean (Standard Deviation)
Unit of Measure: calculated index
732  (420) 272  (226)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Non-Obese, Obese
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.04
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Time Frame 2 years
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title 3 mg DRSP/20 μg EE--normal Weight 3 mg DRSP/20 μg EE- Overweight 3 mg DRSP/20 μg EE- Grade 1 Obese
Hide Arm/Group Description

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

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

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

All-Cause Mortality
3 mg DRSP/20 μg EE--normal Weight 3 mg DRSP/20 μg EE- Overweight 3 mg DRSP/20 μg EE- Grade 1 Obese
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
3 mg DRSP/20 μg EE--normal Weight 3 mg DRSP/20 μg EE- Overweight 3 mg DRSP/20 μg EE- Grade 1 Obese
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/20 (0.00%)   0/21 (0.00%)   0/23 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
3 mg DRSP/20 μg EE--normal Weight 3 mg DRSP/20 μg EE- Overweight 3 mg DRSP/20 μg EE- Grade 1 Obese
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/20 (0.00%)   0/21 (0.00%)   0/23 (0.00%) 
Limitations include evaluation after 24 weeks in a limited number of patients, The time may be too short and sample size too small to measure differences between normal and overweight PCOS women and the use of indirect measures of insulin action.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr Karen Elkind-Hirsch
Organization: Woman's Hospital
Phone: 225-231-5275
EMail: karen.elkind-hirsch@womans.org
Layout table for additonal information
Responsible Party: Karen Elkind-Hirsch, Woman's
ClinicalTrials.gov Identifier: NCT01360996     History of Changes
Other Study ID Numbers: RP 11-003
First Submitted: May 25, 2011
First Posted: May 26, 2011
Results First Submitted: April 19, 2016
Results First Posted: March 31, 2017
Last Update Posted: March 31, 2017