clinical trial in adolescents with ovarian hyperandrogenism and hyperinsulinemia: Effects on ovulatory function, parameters of chronic inflammation, on cardiovascular risk factors and on risk factors for the development of type 2 diabetes

• Conditions: Ovarian hyperandrogenism; Therapeutic area: Diseases [C] - Hormonal diseases [C19]

• Registration Number: EUCTR2012-004100-35-ES
• Lead Sponsor: Fundació per la Recerca i la Docència Sant Joan de Déu

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-10-29
• Last Update Posted: 18 January 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

1) Age equal to or more than 14 years and less than 18 years
2) Menarche at least two years before
3) Body mass index (BMI) below 97th percentile and above the 10th percentile according to age (3)
4) Clinical hyperandrogenism:
a)Hirsutism and/or acne
b)Oligomenorrhea or amenorrhea
5) Biochemical hyperandrogenism:
a)Total testosterone > 60 ng/dL and/or free androgen index > 5 (1.2)
b)Androstenedione > 160 ng/dL
6) Hyperinsulinemia:
a)Basal insulin > 15 ?U/mL
b)Glucose/insulin ratio < 7 or insulin peak in the oral glucose load > 100 ?UmL (1.2)
Are the trial subjects under 18? yes
Number of subjects for this age range: 40
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1)Pregnancy or pregnancy risk: the patient must provide a written guarantee to abstain from intercourse during the study period or agree to use a barrier method of contraception.
2)Congenital adrenal hyperplasia due to 21-hydroxylase deficiency
3)Hyperprolactinemia
4)Cushing's syndrome
5)Uncontrolled hypothyroidism
6)Liver or renal dysfunction of the CPK or the LDH
7)Diabetes or glucose intolerance
8)Known skin allergies
9)Treatment during the previous six months with antiandrogens, estro-progestins, or drugs that interfere with the lipid and carbohydrate metabolism.
10)The existence of known bacterial infections.
11)Inflammatory bowel disease.
12) Patient's with precedents allergy symptons, contraindications or intolerance to the used drugs.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified