Clinical trial in adolescents with ovarian hyperandrogenism and hyperinsulinemia: Effects on ovulatory function, parameters of chronic inflammation, treatment markers of pronostic and effectiveness and the development of type 2 diabetes.

Phase 1

• Conditions: ovarian hyperandrogenism with hyperinsulinaemia; Therapeutic area: Diseases [C] - Hormonal diseases [C19]

• Registration Number: EUCTR2015-005092-24-ES
• Lead Sponsor: FUNDACIÓ SANT JOAN DE DÉ

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-01-22
• Last Update Posted: 9 September 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 40

Inclusion Criteria

1) Age equal to or more than 12 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
4) Clinical hyperandrogenism:
a)Hirsutism and/or acne
b)Oligomenorrhea or amenorrhea
and Biochemical hyperandrogenism:
a)Total testosterone > 60 ng/dL and/or free androgen index > 5
b)Androstenedione > 160 ng/dL
5) Hyperinsulinemia:
a)Basal insulin > 15 µU/mL
b)Glucose/insulin ratio < 7 or insulin peak in the oral glucose test> 100 µUmL
Are the trial subjects under 18? yes
Number of subjects for this age range: 40
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
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
2)Congenital adrenal hyperplasia due to 21-hydroxylase deficiency
3)Hyperprolactinemia
4)Cushing's syndrome
5)Uncontrolled hypothyroidism
6)Liver dysfunction, 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.

Study & Design

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