Comparison of the effects of an oral contraceptive with those of a combined therapy with insulin sensitizers and anti-androgens in young girls with ovarian androgen excess and without pregnancy risk, on markers of cardiometabolic health
- Conditions
- Hyperinsulinemic androgen excess in adolescent girlsNutritional, Metabolic, EndocrineAndrogen excess
- Registration Number
- ISRCTN11062950
- Lead Sponsor
- Hospital Sant Joan de Deu, University of Barcelona
- Brief Summary
2020 Results article in https://pubmed.ncbi.nlm.nih.gov/32342022/ results (added 07/10/2020) 2021 Results article in https://pubmed.ncbi.nlm.nih.gov/33782413/ (added 31/03/2021) 2017 Results article in https://pubmed.ncbi.nlm.nih.gov/28712591/ Primary results (added 12/08/2022)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Female
- Target Recruitment
- 41
1. Hyperinsulinemia, defined as fasting insulinemia >15 IU/mL and/or a peak insulinemia >150 IU/mL and/or mean insulinemia >84 IU/mL on a 2-hour oral glucose tolerance test (oGTT)
2. Presence of both clinical and endocrine androgen excess, as defined by hirsutism score >8 (Ferriman-Gallwey scale), amenorrhea (no menses for more than 3 months) or oligomenorrhea (menstrual intervals >45 days), and high circulating concentrations of testosterone in the follicular phase (cycle day 3-7) or after 2 months of amenorrhea
1. Pregnancy risk (throughout the study)
2. Anemia or bleeding disorder
3. Evidence of thyroid, liver or kidney dysfunction; abnormal electrolytes
4. Hyperprolactinemia
5. 21-hydroxylase deficiency (17-hydroxyprogesterone levels = 200 ng/dL in the follicular phase or after two months of amenorrhea)
6. Glucose intolerance or diabetes mellitus
7. Use of medication affecting gonadal or adrenal function, or carbohydrate or lipid metabolism
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method