Comparison of two therapies for hyperandrogenism in girls

Completed

• Conditions: Hyperinsulinemic ovarian androgen excess; Nutritional, Metabolic, Endocrine; Ovarian dysfunction

• Registration Number: ISRCTN45546616
• Lead Sponsor: Hospital Sant Joan de Déu (Spain)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-04-06
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 46

Inclusion Criteria

1. Adolescent girls (14-17 yr)
2. Two or more yr beyond menarche
3. BMI less than the 97th centile for age
4. Clinical and biochemical signs of androgen excess (hirsutism [Ferriman & Gallwey score >8] and/or acne and/or menstrual irregularities)
5. Total testosterone >60 ng/dL and/or free androgen index >5
6. Hyperinsulinism: fasting insulin >15 uU/mL; glucose/insulin ratio <7, or peak insulin after an OGTT >100 uU/m

Exclusion Criteria

1. Pregnancy or pregnancy risk
2. Late-onset congenital adrenal hyperplasia due to 21-OH deficiency
3. Hyperprolactinemia
4. Cushing's syndrome
5. Hypothyroidism
6. Abnormal liver or kidney function, Creatine Phosphokinase (CPK) or Lactate Dehydrogenase (LDH)
6. Diabetes or impaired glucose tolerance
7. Cutaneous allergies
8. Treatment with anti-androgens, estroprogestagens, or medications interfering with lipid and carbohydrate metabolism during the previous 6 mo
9. Bacterial infections
10. Inflammatory intestinal conditions

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Insulin sensitivity measured by Homeostasis Model Assessment (HOMA) <br>2. Insulin<br>3. Abdominal fat measured by Dual Energy X-Ray Absorptiometry (DXA) <br>4. Abdominal visceral fat and intrahepatic lipid content<br>5. Intermuscular Adipose Tissue (IMAT) measured by Magnetic Resonance (MR)<br>6. Carotid intima media thickness (IMT) measured by Doppler sonography

Secondary Outcome Measures

Name	Time	Method
1. Hirsutism measured by Ferriman & Gallwey score<br>2. Androgens<br>3. Triglycerides<br>4. Ultrasensitive C-reactive protein<br>5. Neutrophile/lymphocyte ratio<br>6. High molecular weight adiponectin<br>7. Changes in the size, number, and distribution of adipocytes determined by subcutaneous adipose tissue biopsy