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

Menopause and Oxidative Stress Study (MOS): Effects of tibolone and oestrogen hormone therapy on oxidative stress associated to mood disturbances, insomnia, loss of muscle function and bone mineral density, that affect self-esteem and quality of life in postmenopausal women

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN14939779

Enrollment

150

Registered

2017-09-19

Start date

2017-10-02

Completion date

Unknown

Last updated

2023-10-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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 Postmenopausal women with or without mood disturbances, insomnia, loss of muscle function and bone mineral density, that affect self-esteem and quality of life.

Interventions

The treatment allocation is done using the simple random method with a scientific calculator. Three groups are formed: 1. Women with 2.5 mg/d of tibolone

Eligibility

Sex/Gender

Female

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
1. Hot flashes is measured using women's self-report diaries regarding how many total hot flashes they had per day during a week as well as information regarding the severity of each of these hot flashes (mild, moderate, severe, or very severe). The diaries are picked up at baseline and every 3 months. 2. Insomnia is measured using the Athens Insomnia Scale (Spanish version) at baseline and every 3 months 3. Depression is measured using the Zung Self-Rating Depression Scale (Spanish version) at baseline and every 3 months 4. Anxiety is measured using the Zung Self-Rating Anxiety Scale (Spanish version) at baseline and every 3 months 5. Quality of life and self-esteem is measured using the WHO Quality of Life-brief and the Coopersmith Self-Esteem Inventory (Spanish version), respectively, at baseline and every 3 months 6. Handgrip strength is measured with a dynamometer and the muscle mass by bioimpedance analysis, as muscle function tests, at baseline and every 6 months 7. Bone mineral density is measured using at the peripheral DXA in hip and column at baseline and every 6 months	—

Measure

Time frame

1. Hot flashes is measured using women's self-report diaries regarding how many total hot flashes they had per day during a week as well as information regarding the severity of each of these hot flashes (mild, moderate, severe, or very severe). The diaries are picked up at baseline and every 3 months. 2. Insomnia is measured using the Athens Insomnia Scale (Spanish version) at baseline and every 3 months 3. Depression is measured using the Zung Self-Rating Depression Scale (Spanish version) at baseline and every 3 months 4. Anxiety is measured using the Zung Self-Rating Anxiety Scale (Spanish version) at baseline and every 3 months 5. Quality of life and self-esteem is measured using the WHO Quality of Life-brief and the Coopersmith Self-Esteem Inventory (Spanish version), respectively, at baseline and every 3 months 6. Handgrip strength is measured with a dynamometer and the muscle mass by bioimpedance analysis, as muscle function tests, at baseline and every 6 months 7. Bone mineral density is measured using at the peripheral DXA in hip and column at baseline and every 6 months

—

Countries

Mexico

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026