Comparison of two therapies for hyperandrogenism in girls

Ethynil-estradiol cyproterone acetate versus low-dose metformin-flutamide-pioglitazone in girls with hyperinsulinemic androgen excess: effects on parameters of chronic inflammation, and on risk factors for type 2 diabetes and cardiovascular disease

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN45546616

Enrollment

Registered

2010-04-06

Start date

2010-02-01

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hyperinsulinemic ovarian androgen excess Nutritional, Metabolic, Endocrine Ovarian dysfunction

Interventions

Current interventions as of 08/02/2011: Adolescents with androgen excess will be allocated to treatment with metformin-flutamide-pioglitazone or ethynil-estradiol-cyproterone acetate over 18 months.

Eligibility

Sex/Gender

Female

Inclusion criteria

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 100 uU/mL

Exclusion criteria

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

Design outcomes

Primary

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

Secondary

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

Countries

Spain

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 10, 2026