Condition category
Nutritional, Metabolic, Endocrine
Date applied
Date assigned
Last edited
Prospectively registered
Overall trial status
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Menopause is an expected event in a woman’s life due to ovarian aging. Ovarian aging is produced by a series of hormonal changes that leads to the erratic production of estrogens that eventually leads to low estrogen levels (menopause). Menopause is associated with multiple symptoms that affects self-esteem and quality of life of the women. The marked reduction in estrogens has been shown to increase levels of oxidative stress (OS) in the body. Oxidative stress is an imbalance between the production of free radicals and the body’s ability to neutralize them by antioxidans. Therefore menopause is a risk factor for OS, which may be due to an estrogenic deficiency and severity of symptoms. Hormone therapy (HT) with estrogen with or without progestin (synthetic progestogens), is a therapeutic alternative for women seeking help to ease their symptoms that occur after menopause, also with antioxidant effect. However, this type of therapy is controversial and can have negative short-term and long-term effects, even leading to treatment withdrawal. An alternative to HT has been the use of tibolone, a molecule with selective activity as estrogen, progestin and androgen, that has effect over postmenopausal symptoms and has not shown side effects, but it has not been clear whether it is an antioxidant molecule. The aim of this study is to determine the effect of tibolone on OS associated with mood disorders, climacteric symptoms, loss of muscle function and bone mineral density, that modify self-esteem and quality of life in postmenopausal women, compared with HT and placebo.

Who can participate?
Women aged 45-59 who have not had menstruation in 12 months.

What does the study involve?
Participants are randomly allocated to one of three groups. Those in the first group receive 2.5 mg/d of tibolone daily for 18 months. Those in the second group receive 0.625 mg/g of synthetic conjugated estrogen as well as 5 mg/10 g of medroxyprogesterone. Those in the last group receive a placebo (a dummy medication). Participants are followed up at six months to measure their oxidative stress and other symptoms.

What are the possible benefits and risks of participating?
The treatment may improve participant’s women postmenopausal symptoms and quality of life. There are no risks to the health for participants with hormone treatment or placebo.

Where is the study run from?
National Autonomous University of Mexico (Mexico)

When is the study starting and how long is it expected to run for?
November 2016 to April 2020 (updated 10/07/2020, previously: July 2019)

Who is funding the study?
National Autonomous University of Mexico (Mexico)

Who is the main contact?
Dr Martha A. Sanchez-Rodriguez

Trial website

Contact information



Primary contact

Dr Martha A. Sanchez-Rodriguez


Contact details

Av. Guelatao No. 66 Col
Ejercito de Oriente
Mexico City
+52 15556230750

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

Scientific title

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



Study hypothesis

Considering that tibolone improves the symptoms present in postmenopausal period, and has a possible antioxidant activity, we assume that women with tibolone therapy will have a decrease in oxidative stress associated with postmenopausal disturbances, improving their quality of life and self-esteem, as well as those taking oestrogen therapy, and with an opposite effect to women receiving placebo.

Ethics approval

Ethics Committee of the Universidad Nacional Autonoma de Mexico, 12/01/2017, ref: FESZ/DEPI/CI/004/17;

Study design

Prospective randomized double-blind trial single-centre

Primary study design


Secondary study design

Randomised controlled trial

Trial setting


Trial type


Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet


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


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
2. Women with 0.625 mg/d of synthetic conjugated oestrogens + 5 mg/10 d of medroxyprogesterone
3. Women taking placebo (pharmaceutical presentation similar to the treatment)
All the treatments are taken by oral administration.

The therapy follow up will be during 18 months with assessments at baseline and ever 6 months.

Intervention type



Not Applicable

Drug names


Primary outcome measure

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

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

Overall trial start date


Overall trial end date


Reason abandoned (if study stopped)


Participant 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

Participant type

Healthy volunteer

Age group




Target number of participants

n= 150, 50 by group

Participant 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

Recruitment start date


Recruitment end date



Countries of recruitment


Trial participating centre

National Autonomous University of Mexico
Faculty of Higher Studies-Zaragoza Guelatao # 66
Mexico City

Sponsor information


National Autonomous University of Mexico

Sponsor details

Av. Universidad 3000
Universidad Nacional Autónoma de México CU
Mexico City

Sponsor type




Funder type


Funder name

National Autonomous University of Mexico

Alternative name(s)

Funding Body Type

Funding Body Subtype


Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer reviewed journal.The study protocol is in Spanish and it is not available on line. Please contact the author to request a copy.

IPD sharing statement:
The datasets generated during and/or analysed during the current study are/will be available upon request from Dr. Martha A. Sanchez-Rodriguez, e-mail: or request a copy in the institutional website:

Intention to publish date


Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

10/07/2020: The following changes were made to the trial record: 1. The recruitment end date was changed from 15/12/2017 to 01/04/2020. 2. The overall end date was changed from 30/07/2019 to 30/04/2020. 3. The intention to publish date was changed from 15/10/2019 to 30/04/2021. 4. The plain English summary was updated to reflect these changes.