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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

Tracking Information
First Submitted Date  ICMJE May 25, 2011
First Posted Date  ICMJE May 26, 2011
Results First Submitted Date  ICMJE April 19, 2016
Results First Posted Date  ICMJE March 31, 2017
Last Update Posted Date March 31, 2017
Study Start Date  ICMJE August 2011
Actual Primary Completion Date February 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 30, 2017)
Biochemical Assessment of Hyperandrogenism [ Time Frame: 24 weeks ]
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
Original Primary Outcome Measures  ICMJE
 (submitted: May 25, 2011)
Biochemical Assessment of Hyperandrogenism [ Time Frame: 24 weeks ]
The primary outcome measures are changes pre and post-treatment in free androgen index {[FAI = testosterone concentration (nmol/l)/ concentration of sex hormone binding globulin [SHBG (nM/L) x100] and adrenal androgen levels of dehydroepiandrosterone sulfate
Change History Complete list of historical versions of study NCT01360996 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 30, 2017)
  • Cardiometabolic Measures [ Time Frame: 24 weeks ]
    Values represent blood pressure at 24 weeks.
  • Post Therapy BMI. [ Time Frame: 24 weeks ]
    Post-treatment body mass index at 24 weeks
  • Biochemical Indicator of B-vitamin Status [ Time Frame: 24 weeks ]
    Post-treatment in folate concentrations after 24 weeks of treatment
  • Menstrual Cycle Regularity [ Time Frame: 24 weeks ]
    Post treatment menstrual frequency over 24 weeks normalized to number of menses per year ..
  • Adrenal Androgen DHEAS [ Time Frame: 24 weeks ]
    Post-treatment levels of adrenal androgen DHEAS
  • Oral Disposition Index [ Time Frame: 24 weeks ]
    Post-treatment insulin secretion-sensitivity index (ISSI) calculated from the oral glucose tolerance test (OGTT). A higher value indicate improved carbohydrate metabolism
Original Secondary Outcome Measures  ICMJE
 (submitted: May 25, 2011)
  • Cardiometabolic Measures [ Time Frame: 24 weeks ]
    Changes pre and post-treatment in blood pressure, lipid profiles and indexes of glucose tolerance and insulin sensitivity
  • anthropometric measures [ Time Frame: 24 weeks ]
    Changes pre- and post-treatment in body mass index, absolute body weight, abdominal adiposity [waist and waist: hip ratio]
  • Biochemical Indicator of B-vitamin Status [ Time Frame: 24 weeks ]
    Changes pre- and post-treatment in folate and vitamin B12 concentrations
  • menstrual cycle regulation [ Time Frame: 24 weeks ]
    Changes in menstrual cyclicity as determined by # menses/24 weeks pre- and post-treatment
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Low Dose OC Therapy in Women With Polycystic Ovary Syndrome (PCOS): Impact of BMI on Hyperandrogenism
Official Title  ICMJE Positive Clinical and Hormonal Effects of Ethinylestradiol Combined With Drospirenone (EE/DRSP) in Women With Polycystic Ovary Syndrome (PCOS): Impact of Body Weight and Relevance to Hyperandrogenism
Brief Summary The classic description of polycystic ovary syndrome (PCOS) is that it is a disorder characterized by menstrual irregularity, chronic anovulation, androgen excess, and abnormal gonadotropin secretion. Use of combined oral contraceptives (OCs) in women with PCOS effectively reduces circulating androgens. Although OCs are the most common and one of the oldest symptomatic treatment modalities for androgenic skin symptoms and for irregular menstrual cycles caused by hyperandrogenism, the data concerning the effect of treatment of PCOS women with different body mass index (BMI) are limited. This study is being done to compare the hormone and metabolic changes after treatment with low-dose oral birth control regimen of DRSP 3 mg/EE 0.02mg/levomefolate calcium 0.451 mg (Beyaz™) in women with PCOS with different body weights.
Detailed Description Clinically, polycystic ovary syndrome (PCOS) is a heterogeneous disorder of functional androgen excess and the features of PCOS can run through a spectrum of severity. The optimal modality for long-term treatment of PCOS should positively influence androgen synthesis, sex hormone binding globulin (SHBG) production, insulin sensitivity, the lipid profile, and clinical symptoms including hirsutism and irregular menstrual cycles. Combined oral contraceptives have been a key component of the chronic treatment of women with PCOS; improving androgen excess and regulating menstrual cycles. The effect of OCs on ovarian folliculogenesis significantly decreases androgen production. This mechanism was confirmed in both healthy women and women with PCOS. In obese patients with PCOS, it is likely that the suppression of androgen production is not as significant. It is thus possible to hypothesize that the effects of OCs in PCOS could be dependent on body weight and what is needed is a head-to-head comparison. The aim of this study is to compare the effect of 6 months of a low-dose oral contraceptive regimen of 24/4 DRSP 3 mg/EE 0.02mg/levomefolate calcium 0.451 mg on androgen profiles, cardiometabolic measures, B-vitamin status, and menstrual cycle regulation in three groups, normal (BMI 18-24.9 kg/ m2) overweight (BMI 25-29.9 kg/ m2) and obese (BMI 30-35 kg/ m2) women with PCOS.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Polycystic Ovary Syndrome
Intervention  ICMJE Drug: 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
Other Names:
  • folate-boosted 3 mg DRSP/20 μg EE-24/4 oral contraceptive
  • BeYaz
Study Arms  ICMJE
  • Experimental: 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

    Intervention: Drug: 3 mg DRSP/20 μg EE
  • Experimental: 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

    Intervention: Drug: 3 mg DRSP/20 μg EE
  • Experimental: 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

    Intervention: Drug: 3 mg DRSP/20 μg EE
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 30, 2017)
64
Original Estimated Enrollment  ICMJE
 (submitted: May 25, 2011)
75
Actual Study Completion Date  ICMJE February 2015
Actual Primary Completion Date February 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • •Adult female-16 years to 35 years of age who have been diagnosed with PCOS desiring contraception

    • Actual BMI >18 to <35kg/ m2
    • Written consent for participation in the study
    • Patient completed lactation

Exclusion Criteria:

  • Metabolic abnormalities requiring pharmacological intervention (except controlled thyroid disease)

    • Uncontrolled hypertension
    • Cancer or history of hormone-dependent cancer
    • History of cholestasis
    • Presence of contradictions for OC administration
    • Personal history of cardiovascular events.
    • Use of drugs known to exacerbate glucose tolerance.
    • No prescription or over-the-counter weight-loss drugs
    • Diabetes
    • Use of medications that affect blood pressure or lipid profile
    • Smoking in past 6 months
    • Known thrombogenic mutations (e.g. Factor V Leiden)
    • Current or history of deep venous thrombosis/pulmonary embolism
    • Major surgery with prolonged immobilization
    • Injectable hormonal contraceptive use within 6 months
    • Use of hormonal (e.g., oral contraceptive [OC] pill) or insulin-sensitizing medication unless willing to cease medications for 3 months before study measurements
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 16 Years to 35 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01360996
Other Study ID Numbers  ICMJE RP 11-003
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Karen Elkind-Hirsch, Woman's
Study Sponsor  ICMJE Woman's
Collaborators  ICMJE Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma
Investigators  ICMJE
Principal Investigator: Karen E Elkind-Hirsch, M.Sc.,Ph.D. Woman's Hospital, Louisiana
Principal Investigator: Martha Paterson, M.D. Woman's Hospital Metabolic Health Clinic
PRS Account Woman's
Verification Date March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP