WithdrawnPhase 4

Investigation of Gender Specificity of the Effects of Furosemide in Healthy Female and Male Volunteers

Stopped: Study was never implemented.

Germany0Started 2012-01

Plain-language summary

In this study the gender specificity of the effects of furosemide in female and male volunteers will be investigated. The main objective is gender-specific comparison of the pharmacokinetic parameters of furosemide in relation to the effect of furosemide (urinary excretion). Secondary objectives are the gender-specific comparison of renal and systemic PAH clearance with the clearance of furosemide and the influence of various genetic polymorphisms on the variability of furosemide pharmacokinetics.

Who can participate

Age range

18 Years – 39 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Healthy volunteer for medical history and physical examination findings * 18 years, \<40 years * Written informed consent is given * No clinically relevant changes in laboratory parameters * Inconspicuous current ECG * taking medication under a different drug trial within the last 30 days Exclusion Criteria: * concomitant medication at study days or a week before * allergies or known hypersensitivity reactions to furosemide or aminohippurate sodium * decreased creatinine clearance by Cockcroft-Gault (\<100 ml / min) * current drug abuses * opiate addiction within the last 10 years * smoking within the last year * pregnancy and 6 months postpartum, lactation * deprivation of legal capacity * Cooperation inability

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

pharmacokinetic parameter of furosemide (AUC-24)

Timeframe: day 1 or day 2

pharmacodynamic parameter of furosemide (Sodium excretion in the urine)

Timeframe: day 1 or day 2

Trial details

NCT IDNCT01156220

SponsorUniversitätsklinikum Hamburg-Eppendorf

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2012-06

View on ClinicalTrials.gov More Healthy Male and Female Volunteers trials