Skip to main content
OpenTrials
Completed

NCT Number: NCT03429231

Observational Study to Evaluate the Quality of Life of Healthy Postmenopausal Women Who Take Coenzyme Q-Ubiquinol

Observational study about quality of life in postmenopausal women taking coenzyme Q compared to another group of women of the same age who do not take it

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Health Status

Study type

Observational

Primary location

Instituto Palacios

Madrid, 28009, Spain

About this study

Observational study to evaluate the subjective assessment performed by healthy postmenopausal women who are taking coenzyme Q for 3 months, compared with other groups of the same characteristics that do not take it

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Postmenopausal woman between 45 and 65 years old
  • Woman who is taking coenzyme Q-Ubiquinol and who will continue taking at least the next 3 months
  • Woman not taking Coenzyme Q-Ubiquinol and not going to take it in the next 3 months

Exclusión Criteria:

  • Patients with severe mental illness.
  • Suspicion or abuse of alcohol or other drugs during the 12 months prior to the selection
  • Any other consideration or finding that, in the opinion of the investigator, considers the non-participation of the subject in the study.

Treatment and study plan

Coenzima Q - QubiquinolCoenzyme Q - Qubiquinol

Dietary Supplement

Patients in the active group will take one tablet a day orally

Primary outcomes

  1. Change from Baseline Quality of Life at 3 months

    Time frame: Baseline and 3 months

    To evaluate the quality of life in healthy postmenopausal women who are taking Coenzyme Q-Ubiquinol for 3 months in comparison with another group that does not take them. The Cervantes Health-Related Quality of Life scale for menopause will be used for this outcome. In that scale next to the 0 and the 5 there are words that describe two opposite answers to the question. Between the 0 and the 5 there are also four boxes numbered 1 to 4. The participants should answer the questions by checking the box that best represents what they think and feel. In other words, they should check 5 if they are completely agree and 0 they are completely disagree. If they are not completely agree or disagree, they should check the boxes in between

Secondary outcomes

  1. Change from Baseline General Health at 3 months

    Time frame: Baseline and 3 months

    Health Scale Euroqol EQ-5D will be used for this outcome

  2. Change from Baseline Mood at three months

    Time frame: Baseline and 3 months

    An analogic scale will be used for this outcome in wich 0 points is the best mood and 10 points is worst mood

  3. Change from Baseline Cramps at three months

    Time frame: Baseline and 3 months

    To assess changes in cramps in patients who had them, a general questionnaire about Cramps will be used to assess mainly the intensity and frequency of crambs. Regarding the intensity 0 is the lower pain and 10 is the worst pain

Sponsors and collaborators

Lead sponsor

Dr. Santiago Palacios

Other

Registry information

Official study title

Observational Study With Food Product to Evaluate the Quality of Life of Healthy Postmenopausal Women Who Take Coenzyme Q-Ubiquinol, Compared With Another Group of the Same Age That Does Not Take coenzymeQ-Ubiquinol

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Feb 12, 2018
Registry last updated
May 11, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.