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

March 30, 2017 updated by: Karen Elkind-Hirsch, Woman's

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

64

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70815
        • Woman's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 35 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
24 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cardiometabolic Measures
Time Frame: 24 weeks
Values represent blood pressure at 24 weeks.
24 weeks
Post Therapy BMI.
Time Frame: 24 weeks
Post-treatment body mass index at 24 weeks
24 weeks
Biochemical Indicator of B-vitamin Status
Time Frame: 24 weeks
Post-treatment in folate concentrations after 24 weeks of treatment
24 weeks
Menstrual Cycle Regularity
Time Frame: 24 weeks
Post treatment menstrual frequency over 24 weeks normalized to number of menses per year ..
24 weeks
Adrenal Androgen DHEAS
Time Frame: 24 weeks
Post-treatment levels of adrenal androgen DHEAS
24 weeks
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
24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Woman's

Collaborators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2011

Primary Completion (ACTUAL)

February 1, 2015

Study Completion (ACTUAL)

February 1, 2015

Study Registration Dates

First Submitted

May 25, 2011

First Submitted That Met QC Criteria

May 25, 2011

First Posted (ESTIMATE)

May 26, 2011

Study Record Updates

Last Update Posted (ACTUAL)

March 31, 2017

Last Update Submitted That Met QC Criteria

March 30, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RP 11-003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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