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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 8, 2016
Last verified: March 2016
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
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
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 Woman's:

Primary Outcome Measures:
  • biochemical assessment of hyperandrogenism [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    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


Secondary Outcome Measures:
  • Cardiometabolic measures [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    Changes pre and post-treatment in blood pressure, lipid profiles and indexes of glucose tolerance and insulin sensitivity

  • anthropometric measures [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    Changes pre- and post-treatment in body mass index, absolute body weight, abdominal adiposity [waist and waist: hip ratio]

  • biochemical indicators of B-vitamin status [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    Changes pre- and post-treatment in folate and vitamin B12 concentrations

  • menstrual cycle regulation [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    Changes in menstrual cyclicity as determined by # menses/24 weeks pre- and post-treatment
Enrollment: 53
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)
Genders 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
Last Updated: March 8, 2016
Health Authority: United States: Institutional Review Board
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by 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
Contraceptive Agents
Contraceptives, Oral
Drospirenone
Folic Acid
Vitamin B Complex
Reproductive Control Agents
Physiological Effects of Drugs
Contraceptive Agents, Female
Mineralocorticoid Receptor Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Diuretics, Potassium Sparing

ClinicalTrials.gov processed this record on September 29, 2016