Low Dose OC Therapy in Women With Polycystic Ovary Syndrome (PCOS): Impact of BMI on Hyperandrogenism (BEYAZ-PCOS)
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ClinicalTrials.gov Identifier: NCT01360996 |
Recruitment Status
:
Completed
First Posted
: May 26, 2011
Results First Posted
: March 31, 2017
Last Update Posted
: March 31, 2017
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Polycystic Ovary Syndrome | Drug: 3 mg DRSP/20 μg EE | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 64 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (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 |
Study Start Date : | August 2011 |
Actual Primary Completion Date : | February 2015 |
Actual Study Completion Date : | February 2015 |

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

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Ages Eligible for Study: | 16 Years to 35 Years (Child, Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01360996
United States, Louisiana | |
Woman's Hospital | |
Baton Rouge, Louisiana, United States, 70815 |
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 |
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 |
First Posted: | May 26, 2011 Key Record Dates |
Results First Posted: | March 31, 2017 |
Last Update Posted: | March 31, 2017 |
Last Verified: | March 2017 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Keywords provided by Karen Elkind-Hirsch, 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 Folic Acid Vitamin B Complex Drospirenone Reproductive Control Agents Physiological Effects of Drugs Contraceptive Agents, Female Hematinics Vitamins Micronutrients Growth Substances |