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

Polycystic Ovary Syndrome Clinical Trial

— BEYAZ-PCOS  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01360996
• Other study ID #: RP 11-003
• Status: Completed
• Phase: Phase 4
• First received: May 25, 2011
• Last updated: March 30, 2017
• Start date: August 2011
• Est. completion date: February 2015

Study information

• Verified date: March 2017
• Source: Woman's
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: February 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 16 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Hyperandrogenism
• Polycystic Ovary Syndrome
• Syndrome

Intervention

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

Locations

Country	Name	City	State
United States	Woman's Hospital	Baton Rouge	Louisiana

Sponsors (2)

Lead Sponsor	Collaborator
Woman's	Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Biochemical Assessment of Hyperandrogenism	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	Cardiometabolic Measures	Values represent blood pressure at 24 weeks.	24 weeks
Secondary	Post Therapy BMI.	Post-treatment body mass index at 24 weeks	24 weeks
Secondary	Biochemical Indicator of B-vitamin Status	Post-treatment in folate concentrations after 24 weeks of treatment	24 weeks
Secondary	Menstrual Cycle Regularity	Post treatment menstrual frequency over 24 weeks normalized to number of menses per year ..	24 weeks
Secondary	Adrenal Androgen DHEAS	Post-treatment levels of adrenal androgen DHEAS	24 weeks
Secondary	Oral Disposition Index	Post-treatment insulin secretion-sensitivity index (ISSI) calculated from the oral glucose tolerance test (OGTT). A higher value indicate improved carbohydrate metabolism	24 weeks