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Effect of PPARγ2 Polymorphism and NSAIDs on Acute Alcohol-induced Changes in Serum Estrogens Among Post-menopausal Women

NCT02463383 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2017-12-12

No results posted yet for this study

Summary

Postmenopausal women, stratified by a peroxisome proliferator-activated receptor gamma-2 (PPARG) polymorphism, were given the following treatments in a random order with a 5w wash-out period: a 400mg ibuprofen tablet or a placebo tablet; both treatments were followed after 30min by a single acute dose of 0.4g alcohol per kg bw. Serum estrogen levels were measured before and at three timepoints after alcohol intake. It is hypothesized that the acute decrease in estrogen sulphate and other markers of estrogens after alcohol intake is modulated by ibuprofen and by PPARG genotype.

Conditions

Interventions

DRUG

Ibuprofen Tab 400 MG

400mg ibuprofen is provided and an alcohol challenge (0.4g/kg bw) is given 30min later

DRUG

Placebo tab

A placebo tablet is provided and an alcohol challenge (0.4g/kg bw) is given 30min later

Sponsors & Collaborators

  • Technical University of Denmark

    collaborator OTHER

  • Professor Lars Ove Dragsted

    lead OTHER

Principal Investigators

  • Lars O Dragsted, PhD · University of Copenhagen

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
50 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-09-30
Primary Completion
2014-10-31
Completion
2015-12-31

Countries

  • Denmark

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02463383 on ClinicalTrials.gov