Low Dose OC Therapy in Women With Polycystic Ovary Syndrome (PCOS): Impact of BMI on Hyperandrogenism
Condition: Polycystic Ovary Syndrome
MeSH terms: Polycystic Ovary Syndrome; Hyperandrogenism; Syndrome
Intervention: 3 mg DRSP/20 μg EE
Intervention description: 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 MeSH terms: Contraceptive Agents; Contraceptives, Oral
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 64.0
Sex: Female
Minimum age: 16 Years
Maximum age: 35 Years
Healthy volunteers: No
Keywords: PCOS

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.
    

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