Menopause Clinical Trial
— BOOM3Official title:
Evaluation de l'efficacité Des Acides Gras oméga 3 Hautement concentrés en EPA Sur Les bouffées de Chaleur, Chez Des Femmes en période de péri-ménopause et ménopause : étude Monocentrique, en Groupes parallèles, contrôlée, randomisée vs Placebo
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 |
The main objective is to evaluate the effects of omega-3 fatty acids on hot flashes frequency.
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) |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
France | Centre d'investigation clinique CIC1406 | GRENOBLE cedex9 |
Lead Sponsor | Collaborator |
---|---|
Vivatech | Centre d'Investigation Clinique de Grenoble CIC1406 |
France,
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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