Low Dose OC Therapy in Women With Polycystic Ovary Syndrome (PCOS): Impact of BMI on Hyperandrogenism
BEYAZ-PCOS
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
1 other identifier
interventional
64
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Aug 2011
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 25, 2011
CompletedFirst Posted
Study publicly available on registry
May 26, 2011
CompletedStudy Start
First participant enrolled
August 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2015
CompletedResults Posted
Study results publicly available
March 31, 2017
CompletedMarch 31, 2017
March 1, 2017
3.5 years
May 25, 2011
April 19, 2016
March 30, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (6)
Cardiometabolic Measures
24 weeks
Post Therapy BMI.
24 weeks
Biochemical Indicator of B-vitamin Status
24 weeks
Menstrual Cycle Regularity
24 weeks
Adrenal Androgen DHEAS
24 weeks
- +1 more secondary outcomes
Study Arms (3)
3 mg DRSP/20 μg EE--normal weight
EXPERIMENTALFolate-boosted 3 mg DRSP/20 μg EE-24/4 oral contraceptive Normal weight -BMI 18-24.9 kg/ m2
3 mg DRSP/20 μg EE- Overweight
EXPERIMENTALFolate-boosted 3 mg DRSP/20 μg EE-24/4 oral contraceptive BMI 25-29.9 kg/ m2
3 mg DRSP/20 μg EE- Grade 1 obese
EXPERIMENTALFolate-boosted 3 mg DRSP/20 μg EE-24/4 oral contraceptive BMI 30-34.9 kg/ m2
Interventions
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Woman's Hospital
Baton Rouge, Louisiana, 70815, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Limitations and Caveats
Limitations include evaluation after 24 weeks in a limited number of patients, The time may be too short and sample size too small to measure differences between normal and overweight PCOS women and the use of indirect measures of insulin action.
Results Point of Contact
- Title
- Dr Karen Elkind-Hirsch
- Organization
- Woman's Hospital
Study Officials
- 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
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Scientific Director of Research
Study Record Dates
First Submitted
May 25, 2011
First Posted
May 26, 2011
Study Start
August 1, 2011
Primary Completion
February 1, 2015
Study Completion
February 1, 2015
Last Updated
March 31, 2017
Results First Posted
March 31, 2017
Record last verified: 2017-03
Data Sharing
- IPD Sharing
- Will not share