A Phase 1 interventional study of Clomiphene and clomiphene and paroxetine in Anovulation, Disorder Due Cytochrome P450 CYP2D6 Variant and Cytochrome P450 CYP3A Enzyme Deficiency, sponsored by Robert Bosch Gesellschaft für Medizinische Forschung mbH. Completed at 1 site in Germany. Open to female participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-02-24.
Sponsored by Robert Bosch Gesellschaft für Medizinische Forschung mbH · Phase 1, Interventional, and Basic science
Aim of the study is the clinical validation of the metabolism and the pharmakokinetic of Clomifen in correlation to CYP2D6 and inhibition of CYP3A4.
75 studies on the registry are indexed under Anovulation; 7 are open to participants now.
This study's enrollment of 20 is below the median of 80 across 52 interventional studies indexed under Anovulation.
Browse Anovulation studies →Robert Bosch Gesellschaft für Medizinische Forschung mbH is the lead sponsor of 7 studies on the registry; none are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
clomiphene, clomiphene and paroxetine, clomiphene and clarithromycin
Drug: Clomiphene · Drug: clomiphene and paroxetine · Drug: clomiphene and clarithromycin
clomiphene, clomiphene and paroxetine, clomiphene and clarithromycin
Drug: Clomiphene · Drug: clomiphene and paroxetine · Drug: clomiphene and clarithromycin
clomiphene, clomiphene and paroxetine, clomiphene and clarithromycin
Drug: Clomiphene · Drug: clomiphene and paroxetine · Drug: clomiphene and clarithromycin
clomiphene, clomiphene and paroxetine, clomiphene and clarithromycin
Drug: Clomiphene · Drug: clomiphene and paroxetine · Drug: clomiphene and clarithromycin
clomiphene once 100 mg oral
Drug pages: Clomiphene · Paroxetine
clomiphene 100mg and paroxetine 3x40mg
Drug pages: Clomiphene · Clarithromycin
clomiphene 100mg and clarithromycin 9x500mg
Area under the plasma concentration versus time curve (AUC)of clomiphene
AUC of clomiphene and metabolites
Time frame: 1, 2, 4, 6, 8, 10, 12, 24, 72 and 168 hours after durg application
Peak Plasma Concentration (Cmax)of Clomiphene
Cmax of Clomiphene and metabolites
Time frame: 1, 2, 4, 6, 8, 10, 12, 24, 72 and 168 hours after drug application
Clearance of Clomiphene
Clearance of Clomiphene and metabolites
Time frame: 4, 8, 12 and 24 hours after drug application
Metabolomic
Metabolomic
Time frame: 4, 8, 12 and 24 hours after drug application
Tmax of clomiphene
Tmax of clomiphene and metabolites
Time frame: 4, 8, 12, 24 hours after drug application
Pharmacogenomics
Pharmacogenomics
Time frame: once
The record gives a start of Dec 2009, a primary completion of Nov 2014 and a completion of Nov 2014. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Feb 2015. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Clomiphene
Robert Bosch Gesellschaft für Medizinische Forschung mbH