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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02062528
Other study ID # DCIC 13 15
Secondary ID
Status Completed
Phase N/A
First received February 12, 2014
Last updated December 8, 2015
Start date March 2014
Est. completion date July 2015

Study information

Verified date December 2015
Source Vivatech
Contact n/a
Is FDA regulated No
Health authority France: ANSM - French Health Products Safety Agency
Study type Interventional

Clinical Trial Summary

The main objective is to evaluate the effects of omega-3 fatty acids on hot flashes frequency.


Recruitment information / eligibility

Status Completed
Enrollment 136
Est. completion date July 2015
Est. primary completion date May 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 35 Years and older
Eligibility Inclusion Criteria:

- menopause or peri menopause

- complaining of hot flashes

- social security affiliation

- informed consent form signed

Exclusion Criteria:

- primary pathology which can lead to hot flashes

- allergy to omega-3 fatty acids

- allergy to sea products

- High consumption of fat fish or produced by the sea

- iatrogenic hot flashes

- actual omega-3 fatty acids consumption or in the 3 last months.

- consumption of drug or other products for hot flashes in the last month

- protected persons (L1121-5 to L1121-8 of French Public health code)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
omega-3 fatty acids
highly dosed in EPA
placebo


Locations

Country Name City State
France Centre d'investigation clinique CIC1406 GRENOBLE cedex9

Sponsors (2)

Lead Sponsor Collaborator
Vivatech Centre d'Investigation Clinique de Grenoble CIC1406

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary hot flashes frequency ANOVA by repeated measures 1 to 8 week No
Secondary hot flashes frequency difference difference betwwen week8 and week4 and week0 4 week and 8 week No
Secondary diurnal hot flashes ANOVA and difference week 1 to 8 No
Secondary night hot flashes ANOVA and difference week 1 to 8 No
Secondary vasomotors disorders ANOVA and differences week 1 to week 8 No
Secondary Pittsburgh Sleep Quality Index (PSQI) sleep quality week 0 and week 8 No
Secondary HFRDIS quality of life week 0 and week 8 No
Secondary The Menopause-Specific Quality of Life (MENQOL) quality of life week 0 and week 8 No
Secondary Weight week 0 and week 8 No
Secondary fatty acids dosage fatty acids dosage week 0 and week 8 No
Secondary number of adverse events week 0 to week 8 Yes
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