CompletedPhase 1

Influence of Pharmacogenetic Factors, Paroxetine and Clarithromycin on Pharmacokinetics of Clomiphene

Germany20 participantsStarted 2009-12

Plain-language summary

Aim of the study is the clinical validation of the metabolism and the pharmakokinetic of Clomifen in correlation to CYP2D6 and inhibition of CYP3A4.

Who can participate

Age range

18 Years – 45 Years

Sex

FEMALE

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 * Female caucasians * Age 18 - 45 years old * BMI 18.5 - 26 kg/m2 Exclusion Criteria: * Persons with known sensitivity of Clomifen and/or Paroxetine and/or Clarithromycin * Pregnancy/lactation period * Meno-/postmenopausal * Smokers

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

Area under the plasma concentration versus time curve (AUC)of clomiphene

Timeframe: 1, 2, 4, 6, 8, 10, 12, 24, 72 and 168 hours after durg application

Peak Plasma Concentration (Cmax)of Clomiphene

Timeframe: 1, 2, 4, 6, 8, 10, 12, 24, 72 and 168 hours after drug application

Trial details

NCT IDNCT01289756

SponsorRobert Bosch Gesellschaft für Medizinische Forschung mbH (RBMF)

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2014-11

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