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

NCT ID: NCT01360996

Last Updated: 2017-03-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-08-31
• Study Completion Date: 2015-02-28

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.

Conditions

Polycystic Ovary Syndrome

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

3 mg DRSP/20 μg EE

Intervention Type: DRUG

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

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

Group Type: EXPERIMENTAL

3 mg DRSP/20 μg EE

Intervention Type: DRUG

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

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

Group Type: EXPERIMENTAL

3 mg DRSP/20 μg EE

Intervention Type: DRUG

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

Interventions

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

Intervention Type: DRUG

Other Intervention Names

folate-boosted 3 mg DRSP/20 μg EE-24/4 oral contraceptive; BeYaz

Eligibility 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

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma

INDUSTRY

Sponsor Role: collaborator

Woman's

OTHER

Sponsor Role: lead

Responsible Party

Karen Elkind-Hirsch

Scientific Director of Research

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Karen E Elkind-Hirsch, M.Sc.,Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Woman's Hospital, Louisiana

Martha Paterson, M.D.

Role: PRINCIPAL_INVESTIGATOR

Woman's Hospital Metabolic Health Clinic

Locations

Woman's Hospital

Baton Rouge, Louisiana, United States

Countries

United States

Other Identifiers

RP 11-003

Identifier Type: -

Identifier Source: org_study_id