Clinical trial · Interventional
Effect of PPARγ2 Polymorphism and NSAIDs on Acute Alcohol-induced Changes in Serum Estrogens Among Post-menopausal Women
Alcohol-related Breast Cancer in Postmenopausal Women - Effect of PPARG2pro12ala Polymorphism on Female Sex-hormone Levels and Interaction With Alcohol Consumption and NSAID Usage
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ibuprofen Tab 400 MG | Drug | — | UNRESOLVED |
| Placebo tab | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Sequence 1
- description
- 1. Ibuprofen Tab 400MG 2. Placebo Tab
- interventionNames
- Drug: Ibuprofen Tab 400 MG
- Drug: Placebo tab
- type
- EXPERIMENTAL
- label
- Sequence 2
- description
- 1. Placebo tab 2. Ibuprofen Tab 400MG
- interventionNames
- Drug: Ibuprofen Tab 400 MG
- Drug: Placebo tab
Primary outcomes (1)
- measure
- Serum estrone sulphate (pmol/l)
- timeFrame
- from 40 min before to 90 min after alcohol consumption
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 50 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: 1. postmenopausal (last menses at least 1 year earlier); 2. having a weekly alcohol use of less than 14 drinks 3. having a BMI of 18-35; Exclusion Criteria: 1. a history of alcohol abuse 2. alcohol abstaining 3. history of hysterectomy before last menses with preservation of both ovaries (unless a medical confirmation for the postmenopausal status exists or the participant is 60 years or older); 4. major health problems, such as ulcers, heart diseases, diabetes or cancer 5. previous or current use of HRT 6. taking prescription medications that could interfere with the study (i.e. daily use of NSAIDs and/or medication that interact with PPARγ e.g. cholesterol lowering medicine); 7. being allergic to alcohol and/or Ibuprofen 8. smoking
References
Publications (1)
- DERIVEDKopp TI, Jensen DM, Ravn-Haren G, Cohen A, Sommer HM, Dragsted LO, Tjonneland A, Hougaard DM, Vogel U. Alcohol-related breast cancer in postmenopausal women - effect of CYP19A1, PPARG and PPARGC1A polymorphisms on female sex-hormone levels and interaction with alcohol consumption and NSAID usage in a nested case-control study and a randomised controlled trial. BMC Cancer. 2016 Apr 21;16:283. doi: 10.1186/s12885-016-2317-y. PMID 27102200