NCT02869763

Brief Summary

The aim of the clinical trial is to study the intra-individual variation of steroid profile parameters after experimental administration of different doses of ethanol in Caucasian women.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 28, 2016

Completed
20 days until next milestone

First Posted

Study publicly available on registry

August 17, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
Last Updated

October 6, 2017

Status Verified

October 1, 2017

Enrollment Period

6 months

First QC Date

July 28, 2016

Last Update Submit

October 4, 2017

Conditions

Alcohol ConsumptionHealthy

Keywords

EthanolSteroid profilePharmacokinetics

Outcome Measures

Primary Outcomes (3)

  • Change from baseline steroid profile

    24 hours urine will be collected before each experimental session and also up to 24 hours after administration.

    From one day before administration till 24 hours after administration

  • Change from baseline Ethyl glucuronide concentrations

    Ethyl glucuronide in urine will be measured by Liquid chromatography-mass spectrometry (LC-MS) using deuterated analogs as Internal Standards.

    From baseline till 24 hours after administration

  • Change from baseline Urine Ethyl sulfate concentrations

    Ethyl sulfate in urine will be measured by Liquid chromatography-mass spectrometry (LC-MS) using deuterated analogs as Internal Standards.

    From baseline till 24 hours after administration

Secondary Outcomes (10)

  • Change from baseline alcohol breath air concentrations

    From baseline till 6 hours after administration

  • Urine Creatinine concentrations

    From one day before administration till 24 hours after administration

  • Change from baseline subjective effects of ethanol

    From baseline till 6 hours after administration

  • Number of Participants with Serious and Non-Serious Adverse Events

    Through study completion, an average of 1 year

  • Change from baseline heart rate

    From baseline to 6 hours after administration

  • +5 more secondary outcomes

Study Arms (3)

10 g ethanol

EXPERIMENTAL

31 mL of Vodka Absolut® diluted in 369 mL of lemon flavored-water (LFW) Fontvella®. A total volume of 400 mL of the drink will be administered, distributed in three 133 mL cool glasses. Administration of ethanol beverage will be controlled: participants will have 5 minutes to drink each glass.

Dietary Supplement: 10 g ethanol

20 g ethanol

EXPERIMENTAL

63 mL of Vodka Absolut® diluted in 337 mL of lemon flavored-water (LFW) Fontvella®. A total volume of 400 mL of the drink will be administered, distributed in three 133 mL cool glasses. Administration of ethanol beverage will be controlled: participants will have 5 minutes to drink each glass.

Dietary Supplement: 20 g ethanol

Water

PLACEBO COMPARATOR

400 mL of lemon flavored-water Fontvella®. A total volume of 400 mL of the drink will be administered, distributed in three 133 mL cool glasses. The administration will be controlled: participants will have 5 minutes to drink each glass.

Dietary Supplement: Water

Interventions

10 g ethanolDIETARY_SUPPLEMENT

31 mL of Vodka Absolut® diluted in 369 mL of lemon flavored-water (LFW) Fontvella®. A total volume of 400 mL of the drink will be administered, distributed in three 133 mL cool glasses. Administration of ethanol beverage will be controlled: participants will have 5 minutes to drink each glass.

Also known as: Vodka Absolut®
10 g ethanol
20 g ethanolDIETARY_SUPPLEMENT

63 mL of Vodka Absolut® diluted in 337 mL of lemon flavored-water (LFW) Fontvella®. A total volume of 400 mL of the drink will be administered, distributed in three 133 mL cool glasses. Administration of ethanol beverage will be controlled: participants will have 5 minutes to drink each glass.

Also known as: Vodka Absolut®
20 g ethanol
WaterDIETARY_SUPPLEMENT

400 mL of lemon flavored-water Fontvella®. A total volume of 400 mL of the drink will be administered, distributed in three 133 mL cool glasses. The administration will be controlled: participants will have 5 minutes to drink each glass.

Also known as: Lemon flavored-water Fontvella®
Water

Eligibility Criteria

Age18 Years - 55 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Participants will be healthy women aged 18 to 55 years. Women will enter in studies at the follicular phase of the menstrual cycle, in order to avoid the interference of estrogens.
  • Female subjects (if not postmenopausal) possessing regular menstrual cycle between 26 and 32 days and willing to use effective methods of contraception through the study (sexual abstinence, vasectomized partner, sterilization, intrauterine device, double-barrier method).
  • Clinical history and physical examination demonstrating no organic or psychiatric disorders.
  • The ECG and general blood and urine laboratory tests performed before the study should be within normal ranges. Minor or occasional changes from normal ranges are accepted if, in the investigator's opinion, considering the current state of the art, they are not clinically significant, are not life-threatening for the subjects and do not interfere with the product assessment. These changes and their non-relevance will be justified in writing specifically.
  • The body mass index (BMI=weigh/height2) will range from 18.5 to 29.9 kg/m2, and the weight from 50 to 100 kg.
  • Understanding and accepting the study procedures and signing the informed consent.
  • Agreeing to follow a diet free from ethanol in the 72 hours prior to the start of each session and until the end of the study.
  • Subjects with social or recreational alcohol consumption, at least 3 standard drinks/week and subjects with experience in several drunkenness.

You may not qualify if:

  • History or clinical evidence of alcoholism, drug abuse, or regular use of psychoactive drugs.
  • Having suffered any organic disease or major surgery in the three months prior to the study start.
  • History of psychiatric disorders.
  • Women presenting amenorrhea or who suffer from moderate to intense premenstrual syndrome. Female subjects using hormonal contraceptive hormones.
  • Smokers of more than 20 cigarettes per day.
  • Taking more than 30 g of alcohol a day
  • Ingestion of vitamin supplements or antioxidants or nonsteroidal anti-inflammatory drugs in the two weeks preceding the study.
  • Blood donation 8 weeks before or participation in other clinical trials with drugs in the previous 12 weeks.
  • Subjects with intolerance or adverse reactions to ethanol.
  • Subjects who have suffered a hospitalization caused by alcohol intoxication or who have received treatment for drunkenness
  • History or clinical evidence of gastrointestinal, liver, renal or other disorders which may lead to suspecting a disorder in drug absorption, distribution, metabolism or excretion, or that suggest gastrointestinal irritation due to drugs.
  • Subjects unable to understand the nature, consequences of the study and the procedures requested to be followed.
  • Subjects with positive serology to Hepatitis B, C or HIV.
  • Subjects who follow a vegetarian diet.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Parc Salut Mar

Barcelona, 08003, Spain

Location

Related Publications (20)

  • Arranz S, Chiva-Blanch G, Valderas-Martinez P, Medina-Remon A, Lamuela-Raventos RM, Estruch R. Wine, beer, alcohol and polyphenols on cardiovascular disease and cancer. Nutrients. 2012 Jul;4(7):759-781. doi: 10.3390/nu4070759. Epub 2012 Jul 10.

    PMID: 22852062RESULT

  • Bagnardi V, Zatonski W, Scotti L, La Vecchia C, Corrao G. Does drinking pattern modify the effect of alcohol on the risk of coronary heart disease? Evidence from a meta-analysis. J Epidemiol Community Health. 2008 Jul;62(7):615-9. doi: 10.1136/jech.2007.065607.

    PMID: 18559444RESULT

  • Dahl H, Hammarberg A, Franck J, Helander A. Urinary ethyl glucuronide and ethyl sulfate testing for recent drinking in alcohol-dependent outpatients treated with acamprosate or placebo. Alcohol Alcohol. 2011 Sep-Oct;46(5):553-7. doi: 10.1093/alcalc/agr055. Epub 2011 May 26.

    PMID: 21616946RESULT

  • Dahl H, Stephanson N, Beck O, Helander A. Comparison of urinary excretion characteristics of ethanol and ethyl glucuronide. J Anal Toxicol. 2002 May-Jun;26(4):201-4. doi: 10.1093/jat/26.4.201.

    PMID: 12054359RESULT

  • Jatlow PI, Agro A, Wu R, Nadim H, Toll BA, Ralevski E, Nogueira C, Shi J, Dziura JD, Petrakis IL, O'Malley SS. Ethyl glucuronide and ethyl sulfate assays in clinical trials, interpretation, and limitations: results of a dose ranging alcohol challenge study and 2 clinical trials. Alcohol Clin Exp Res. 2014 Jul;38(7):2056-65. doi: 10.1111/acer.12407. Epub 2014 Apr 28.

    PMID: 24773137RESULT

  • Di Castelnuovo A, Costanzo S, Bagnardi V, Donati MB, Iacoviello L, de Gaetano G. Alcohol dosing and total mortality in men and women: an updated meta-analysis of 34 prospective studies. Arch Intern Med. 2006 Dec 11-25;166(22):2437-45. doi: 10.1001/archinte.166.22.2437.

    PMID: 17159008RESULT

  • Falk O, Palonek E, Bjorkhem I. Effect of ethanol on the ratio between testosterone and epitestosterone in urine. Clin Chem. 1988 Jul;34(7):1462-4.

    PMID: 3390919RESULT

  • Gaedigk A, Twist GP, Leeder JS. CYP2D6, SULT1A1 and UGT2B17 copy number variation: quantitative detection by multiplex PCR. Pharmacogenomics. 2012 Jan;13(1):91-111. doi: 10.2217/pgs.11.135. Epub 2011 Nov 23.

    PMID: 22111604RESULT

  • Grosse J, Anielski P, Sachs H, Thieme D. Ethylglucuronide as a potential marker for alcohol-induced elevation of urinary testosterone/epitestosterone ratios. Drug Test Anal. 2009 Nov;1(11-12):526-30. doi: 10.1002/dta.110.

    PMID: 20355168RESULT

  • Halter CC, Dresen S, Auwaerter V, Wurst FM, Weinmann W. Kinetics in serum and urinary excretion of ethyl sulfate and ethyl glucuronide after medium dose ethanol intake. Int J Legal Med. 2008 Mar;122(2):123-8. doi: 10.1007/s00414-007-0180-8. Epub 2007 Jun 9.

    PMID: 17558515RESULT

  • Jakobsson J, Ekstrom L, Inotsume N, Garle M, Lorentzon M, Ohlsson C, Roh HK, Carlstrom K, Rane A. Large differences in testosterone excretion in Korean and Swedish men are strongly associated with a UDP-glucuronosyl transferase 2B17 polymorphism. J Clin Endocrinol Metab. 2006 Feb;91(2):687-93. doi: 10.1210/jc.2005-1643. Epub 2005 Dec 6.

    PMID: 16332934RESULT

  • American Heart Association Nutrition Committee; Lichtenstein AH, Appel LJ, Brands M, Carnethon M, Daniels S, Franch HA, Franklin B, Kris-Etherton P, Harris WS, Howard B, Karanja N, Lefevre M, Rudel L, Sacks F, Van Horn L, Winston M, Wylie-Rosett J. Diet and lifestyle recommendations revision 2006: a scientific statement from the American Heart Association Nutrition Committee. Circulation. 2006 Jul 4;114(1):82-96. doi: 10.1161/CIRCULATIONAHA.106.176158. Epub 2006 Jun 19.

    PMID: 16785338RESULT

  • Rinaldi S, Peeters PH, Bezemer ID, Dossus L, Biessy C, Sacerdote C, Berrino F, Panico S, Palli D, Tumino R, Khaw KT, Bingham S, Allen NE, Key T, Jensen MK, Overvad K, Olsen A, Tjonneland A, Amiano P, Ardanaz E, Agudo A, Martinez-Garcia C, Quiros JR, Tormo MJ, Nagel G, Linseisen J, Boeing H, Schulz M, Grobbee DE, Bueno-de-Mesquita HB, Koliva M, Kyriazi G, Thrichopoulou A, Boutron-Ruault MC, Clavel-Chapelon F, Ferrari P, Slimani N, Saracci R, Riboli E, Kaaks R. Relationship of alcohol intake and sex steroid concentrations in blood in pre- and post-menopausal women: the European Prospective Investigation into Cancer and Nutrition. Cancer Causes Control. 2006 Oct;17(8):1033-43. doi: 10.1007/s10552-006-0041-7.

    PMID: 16933054RESULT

  • Santner SJ, Albertson B, Zhang GY, Zhang GH, Santulli M, Wang C, Demers LM, Shackleton C, Santen RJ. Comparative rates of androgen production and metabolism in Caucasian and Chinese subjects. J Clin Endocrinol Metab. 1998 Jun;83(6):2104-9. doi: 10.1210/jcem.83.6.4898.

    PMID: 9626146RESULT

  • Snell LD, Ramchandani VA, Saba L, Herion D, Heilig M, George DT, Pridzun L, Helander A, Schwandt ML, Phillips MJ, Hoffman PL, Tabakoff B; WHO/ISBRA Study on State and Trait Markers of Alcohol Use and Dependence Investigators. The biometric measurement of alcohol consumption. Alcohol Clin Exp Res. 2012 Feb;36(2):332-41. doi: 10.1111/j.1530-0277.2011.01605.x. Epub 2011 Sep 6.

    PMID: 21895709RESULT

  • Sottas PE, Saugy M, Saudan C. Endogenous steroid profiling in the athlete biological passport. Endocrinol Metab Clin North Am. 2010 Mar;39(1):59-73, viii-ix. doi: 10.1016/j.ecl.2009.11.003.

    PMID: 20122450RESULT

  • Starcevic B, Butch AW. Genetic variations in UDP-glucuronosyl transferase 2B17: implications for testosterone excretion profiling and doping control programs. Clin Chem. 2008 Dec;54(12):1945-7. doi: 10.1373/clinchem.2008.110106. Epub 2008 Oct 16. No abstract available.

    PMID: 18927247RESULT

  • Strahm E, Sottas PE, Schweizer C, Saugy M, Dvorak J, Saudan C. Steroid profiles of professional soccer players: an international comparative study. Br J Sports Med. 2009 Dec;43(14):1126-30. doi: 10.1136/bjsm.2008.056242. Epub 2009 Mar 12.

    PMID: 19282302RESULT

  • Thieme D, Grosse J, Keller L, Graw M. Urinary concentrations of ethyl glucuronide and ethyl sulfate as thresholds to determine potential ethanol-induced alteration of steroid profiles. Drug Test Anal. 2011 Nov-Dec;3(11-12):851-6. doi: 10.1002/dta.396.

    PMID: 22213685RESULT

  • Xu L, Au Yeung SL, Kavikondala S, Leung GM, Schooling CM. Testosterone concentrations in young healthy US versus Chinese men. Am J Hum Biol. 2014 Jan-Feb;26(1):99-102. doi: 10.1002/ajhb.22482. Epub 2013 Nov 19.

    PMID: 24254402RESULT

MeSH Terms

Conditions

Alcohol Drinking

Interventions

EthanolWater

Condition Hierarchy (Ancestors)

Drinking BehaviorBehavior

Intervention Hierarchy (Ancestors)

AlcoholsOrganic ChemicalsHydroxidesAlkaliesInorganic ChemicalsAnionsIonsElectrolytesOxidesOxygen Compounds

Study Officials

  • Rafael de la Torre, PhD

    IMIM-Hospital del Mar Medical Research Institute

    PRINCIPAL INVESTIGATOR

  • José Antonio Pascual, PhD

    IMIM-Hospital del Mar Medical Research Institute

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD Pharm D

Study Record Dates

First Submitted

July 28, 2016

First Posted

August 17, 2016

Study Start

May 1, 2016

Primary Completion

November 1, 2016

Study Completion

September 1, 2017

Last Updated

October 6, 2017

Record last verified: 2017-10

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)