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
Study type: Interventional
Phase: Phase 4

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.
    

Intervention name(s): 3 mg DRSP/20 μg EE
Intervention type(s): Drug
Intervention description(s): 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 intervention name(s): folate-boosted 3 mg DRSP/20 μg EE-24/4 oral contraceptive; BeYaz
Intervention MeSH terms: Contraceptive Agents; Contraceptives, Oral
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: PCOS