ClinicalTrials.gg
CompletedNCT03429231Updated May 11, 2018

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

An observational study in Health Status, sponsored by Dr. Santiago Palacios. Completed at 1 site in Spain. Per ClinicalTrials.gov, last updated 2018-05-11.

Sponsored by Dr. Santiago Palacios · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
40
01

Study summary

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

Read the detailed description

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

02

Conditions studied

  • Health Status
03

In context

Lead sponsor

Dr. Santiago Palacios is the lead sponsor of 4 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sampling method
Non-probability sample

Study population

Healthy postmenopausal woman between 45 and 65 years

Eligibility criteria

Inclusion Criteria:

  • 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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Postmenopausal

Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
40 participants (actual)
Patient registry
No

Groups and cohorts

  • Active Group

    Women who are taking coenzyme Q and who will continue taking it for 3 months

    Dietary Supplement: Coenzima Q - QubiquinolCoenzyme Q - Qubiquinol

  • Control Group

    Women who are not taking coenzyme Q and who will not take it in the next 3 months

Interventions

  • Dietary supplementCoenzima Q - QubiquinolCoenzyme Q - Qubiquinol

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

06

What researchers measure

Primary outcomes

  1. Change from Baseline Quality of Life at 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

    Time frame: Baseline and 3 months

Secondary outcomes

  1. Change from Baseline General Health at 3 months

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

    Time frame: Baseline and 3 months

  2. Change from Baseline Mood at three months

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

    Time frame: Baseline and 3 months

  3. Change from Baseline Cramps at three 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

    Time frame: Baseline and 3 months

07

Study locations

1 site
  • Instituto Palacios
    Madrid, 28009, Spain
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Nov 2017 to primary completion in Mar 2018, 4 months.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 16, 2018
First posted
Feb 12, 2018
StartActual
Nov 23, 2017
Primary completionActual
Mar 31, 2018
CompletionActual
Apr 15, 2018
Last update
May 11, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 11, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03429231
Lead sponsor
Dr. Santiago Palacios
Responsible party
Dr. Santiago Palacios (Principal Investigator, Instituto Palacios) — Sponsor-investigator
First posted
Feb 12, 2018
Start date
Nov 23, 2017
Primary completion
Mar 31, 2018
Completion
Apr 15, 2018
Last update
May 11, 2018

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2018. You cannot join it, but the record below documents what was studied.

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