Clinical trial NCT01360996: Low Dose OC Therapy in Women With Polycystic Ovary Syndrome (PCOS): Impact of BMI on Hyperandrogenism
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Polycystic Ovary Syndrome
Keywords: PCOS
Lead sponsor: Woman's
Sponsor class: OTHER
Collaborators: name: Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma
First posted: 2011-05-26
Enrollment: 64
Sex: FEMALE
Minimum age (years): 16
Maximum age (years): 35
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

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

Primary outcomes:
measure: Biochemical Assessment of Hyperandrogenism
timeFrame: 24 weeks
Secondary outcomes:
measure: Cardiometabolic Measures
timeFrame: 24 weeks
measure: Post Therapy BMI.
timeFrame: 24 weeks
measure: Biochemical Indicator of B-vitamin Status
timeFrame: 24 weeks
measure: Menstrual Cycle Regularity
timeFrame: 24 weeks
measure: Adrenal Androgen DHEAS
timeFrame: 24 weeks
measure: Oral Disposition Index
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Baton Rouge
country: United States
facility: Woman's Hospital
state: Louisiana
Study officials:
affiliation: Woman's Hospital, Louisiana
name: Karen E Elkind-Hirsch, M.Sc.,Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Woman's Hospital Metabolic Health Clinic
name: Martha Paterson, M.D.
role: PRINCIPAL_INVESTIGATOR
References: