Metabolic and hormonal effects of weight loss in patients with polycystic ovary syndrome

Not Applicable

Completed

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

• Registration Number: ISRCTN48947168
• Lead Sponsor: Karolinska Institutet (Sweden)

Brief Summary

2019 Results article in https://www.ncbi.nlm.nih.gov/pubmed/30565716 results (added 04/12/2019) 2023 Other publications in https://pubmed.ncbi.nlm.nih.gov/36843616/ Secondary analysis (added 28/02/2023)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-11-16
• Study Completion: 2016-05-28
• Last Update Posted: 13 March 2023

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 40

Inclusion Criteria

1. All criteria for the diagnosis of PCOS should be met (anovulation, hyperandrogenism, polycystic ovaries)
2. 18-40 years
3. BMI between 27 and 38
4. No medication or hormone-containing contraceptives
5. If any kind of hormonal contraception, acceptance for three months of wash-out period before entering the study
6. Accepting a non-hormonal method of contraception such as condoms, IUD during the study or be sterilized
7. Willing to give informed consent in writing

Exclusion Criteria

1. Smoking
2. Use of hormone-containing contraceptives
3. Chronic Illness
4. Ongoing medication

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> Weight change<br><br> Added 04/12/2019: measured in kilograms and a percentage at baseline, 4 and 12 months<br>