Ethinyloestradiol-Levonorgestrel versus Low-Dose Spironolactone-Pioglitazone-Metformin for Adolescent Girls with Polycystic Ovary Syndrome: On-Treatment and Post-Treatment Observations.

Not Applicable

Completed

• Conditions: Polycystic ovary syndrome; Nutritional, Metabolic, Endocrine; Polycystic ovarian syndrome

• Registration Number: ISRCTN29234515
• Lead Sponsor: Hospital Sant Joan de Deu

Brief Summary

2017 results in: https://www.ncbi.nlm.nih.gov/pubmed/28712591 (added 29/01/2019) 2021 results in https://pubmed.ncbi.nlm.nih.gov/33782413/ (added 31/03/2021)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-08-08
• Study Completion: 2016-06-20
• Last Update Posted: 12 April 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 42

Inclusion Criteria

As of 21/07/2016:
1. Clinical androgen excess (hirsutism) and/or biochemical hyperandrogenismwith or without biochemical androgen excess
2. Chronological age between 14.0-17.9 years at study start
3. Gynecological age (= time post-menarche) >2.0 years at study start
4. Absence of sexual activity (intercourse)

Initial:
1.Clinical and biochemical hyperandrogenism
2. Hyperinsulinemia (fasting and/or after an oGTT)
3. Age >14 and >18 year
4. Menarche at least 2 years before
5. BMI <97th percentile and >10th percentile

Exclusion Criteria

As of 21/07/2016:
1. Evidence for adrenal hyperplasia, Cushing syndrome, hypothyroidism
2. Evidence for lLiver or kidney dysfunction, diabetes, glucose intolerance
3. Treatment with oral contraceptives, antiandrogens, or insulin sensitizers in past 6 months

Initial:
1. Pregnancy or pregnancy risk
2. Late onset congenital adrenal hyperplasia, Cushing's syndrome, uncompensated hypothyroidism
3. Liver or renal dysfunction, diabetes, glucose intolerance
4. Treatment with oral contraceptives, antiandrogens, or insulin sensitizers over the previous 6 months
5. Severe bacterial infections

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> As of 21/07/2016:<br> 1. Post-treatment ovulation rate: (judged by a combination of menstrual history and weekly salivary progesterone concentrations for 12 consecutive weeks, in the second and the fourth quarters of the first post-treatment year (months 15-18 and 21-24 of the study).<br><br> As of 15/03/2016:<br> 1. Ovulation rate: (weekly salivary progesterone for 12 consecutive weeks, ELISA): post-treatment; second and fourth quarters of the post-treatment year (months 15-18 and 21-24)<br><br> Initial<br> 1. Fasting insulin<br> 2. Visceral fat<br> 3. Hepatic fat<br> 4. Carotid intima-media thickness<br>