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

This study has been completed.
Sponsor:
Collaborator:
Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma
Information provided by (Responsible Party):
Karen Elkind-Hirsch, Woman's
ClinicalTrials.gov Identifier:
NCT01360996
First received: May 25, 2011
Last updated: March 30, 2017
Last verified: March 2017
History of Changes
  Purpose
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.

Condition Intervention Phase
Polycystic Ovary Syndrome
 Drug: 3 mg DRSP/20 μg EE
 Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Karen Elkind-Hirsch, Woman's:

Primary Outcome Measures:
  • 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



Secondary Outcome Measures:
  • 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
Enrollment: 64
Study Start Date: August 2011
Study Completion Date: February 2015
Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

 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
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

 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
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

 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

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.
  Eligibility
Ages Eligible for Study:   16 Years to 35 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01360996

Locations
United States, Louisiana
Woman's Hospital
Baton Rouge, Louisiana, United States, 70815
Sponsors and Collaborators
Woman's
Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma
Investigators
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
  More Information

Responsible Party: Karen Elkind-Hirsch, Scientific Director of Research, Woman's
ClinicalTrials.gov Identifier: NCT01360996     History of Changes
Other Study ID Numbers: RP 11-003
Study First Received: May 25, 2011
Results First Received: April 19, 2016
Last Updated: March 30, 2017
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by Karen Elkind-Hirsch, Woman's:
PCOS

Additional relevant MeSH terms:
Polycystic Ovary Syndrome
Syndrome
Hyperandrogenism
Disease
Pathologic Processes
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases
46, XX Disorders of Sex Development
Disorders of Sex Development
 Urogenital Abnormalities
Adrenogenital Syndrome
Congenital Abnormalities
Folic Acid
Vitamin B Complex
Contraceptive Agents
Contraceptives, Oral
Drospirenone
Hematinics
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Reproductive Control Agents
Contraceptive Agents, Female

ClinicalTrials.gov processed this record on May 25, 2017