Double-blind placebo controlled trial of tibolone and oestrogen hormone therapy on oxidative stress associated to postmenopausal disturbances in women with early postmenopause: MOS study
Not Applicable
Completed
- Conditions
- Postmenopausal women with or without mood disturbances, insomnia, loss of muscle function and bone mineral density, that affect self-esteem and quality of life.Nutritional, Metabolic, Endocrine
- Registration Number
- ISRCTN14939779
- Lead Sponsor
- ational Autonomous University of Mexico
- Brief Summary
2021 Other publications in https://doi.org/10.1155/2021/9971765 Oxidative Stress Risk Is Increased with a Sedentary Lifestyle during Aging in Mexican Women (added 11/10/2023)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Female
- Target Recruitment
- 150
Inclusion Criteria
1. Women aged 45-59 with intact uterus
2. At least 12 months of spontaneous amenorrhea and/or serum estradiol levels less 25 pg/mL and follicle stimulating hormone (FSH) levels higher 50 mU/mL
Exclusion Criteria
1. Women with cardiovascular, renal, hepatic or cancer disease
2. Antioxidant supplement intake for at least six months prior to the beginning of the study
2. Previous hormone therapy
3. Those who do not agree to participate in the study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Oxidative stress is measured using lipoperoxide levels by TBARS assay, erythrocyte superoxide dismutase (SOD), erythrocyte glutathione peroxidase (GPx), total plasma antioxidant status and uric acid, using Randox Laboratories kits, at baseline measurement prior to initiation of therapy, and every 3 months.
- Secondary Outcome Measures
Name Time Method