AnovulationPhase 1NCT01289756
Influence of Pharmacogenetic Factors, Paroxetine and Clarithromycin on Pharmacokinetics of Clomiphene
A Phase 1 study testing Clomiphene, clomiphene and paroxetine and clomiphene and clarithromycin in people with Anovulation and Disorder Due Cytochrome P450 CYP2D6 Variant, run by Robert Bosch Gesellschaft für Medizinische Forschung mbH (RBMF) at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Anovulation, Disorder Due Cytochrome P450 CYP2D6 Variant, Cytochrome P450 CYP3A Enzyme Deficiency
- What is being tested?
- Clomiphene, clomiphene and paroxetine and clomiphene and clarithromycin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteGermany
- Study dates
- Dec 2009to Nov 2014
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy
- Female caucasians
- Age 18 - 45 years old
- BMI 18.5 - 26 kg/m2
Who cannot join
- Persons with known sensitivity of Clomifen and/or Paroxetine and/or Clarithromycin
- Pregnancy/lactation period
- Meno-/postmenopausal
- Smokers
Trial locations and contacts
1 site in 1 country.
Germany1 site
Dr. Margarete Fischer-Bosch-Institute of Clinical Pharmacology and University of Tuebingen
Stuttgart, Baden-Wurttemberg, 70376
About this study
Aim of the study is the clinical validation of the metabolism and the pharmakokinetic of Clomifen in correlation to CYP2D6 and inhibition of CYP3A4.
- Conditions
- Anovulation, Disorder Due Cytochrome P450 CYP2D6 Variant, Cytochrome P450 CYP3A Enzyme Deficiency
- Being tested
- Clomiphene, clomiphene and paroxetine, clomiphene and clarithromycin
- Keywords
- pharmacokinetic, clomiphene, CYP2D6 polymorphisms, inhibition of CYP2D6 and CYP3A4
- Medical subject headings
- Anovulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ClomipheneDrug
clomiphene once 100 mg oral
clomiphene and paroxetineDrug
clomiphene 100mg and paroxetine 3x40mg
clomiphene and clarithromycinDrug
clomiphene 100mg and clarithromycin 9x500mg
| Study group | Role | What they receive |
|---|---|---|
| CYP2D6 EM | Experimental | clomiphene, clomiphene and paroxetine, clomiphene and clarithromycin Receives: Drug: Clomiphene; Drug: clomiphene and paroxetine; Drug: clomiphene and clarithromycin |
| CYP2D6 IM | Experimental | clomiphene, clomiphene and paroxetine, clomiphene and clarithromycin Receives: Drug: Clomiphene; Drug: clomiphene and paroxetine; Drug: clomiphene and clarithromycin |
| CYP2D6 PM | Experimental | clomiphene, clomiphene and paroxetine, clomiphene and clarithromycin Receives: Drug: Clomiphene; Drug: clomiphene and paroxetine; Drug: clomiphene and clarithromycin |
| CYP2D6 UM | Experimental | clomiphene, clomiphene and paroxetine, clomiphene and clarithromycin Receives: Drug: Clomiphene; Drug: clomiphene and paroxetine; Drug: clomiphene and clarithromycin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the plasma concentration versus time curve (AUC)of clomiphene
AUC of clomiphene and metabolites
Measured: 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
Measured: 1, 2, 4, 6, 8, 10, 12, 24, 72 and 168 hours after drug application
Secondary outcomes (4)
Clearance of Clomiphene
Clearance of Clomiphene and metabolites
Measured: 4, 8, 12 and 24 hours after drug application
Metabolomic
Metabolomic
Measured: 4, 8, 12 and 24 hours after drug application
Tmax of clomiphene
Tmax of clomiphene and metabolites
Measured: 4, 8, 12, 24 hours after drug application
Pharmacogenomics
Pharmacogenomics
Measured: once
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2011 (estimated)
- Study startDec 2009
- Primary completionNov 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnovulationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Robert Bosch Gesellschaft für Medizinische Forschung mbH (RBMF)
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matthias Schwab, Robert Bosch Gesellschaft für Medizinische Forschung mbH (RBMF)
- Investigators
- Matthias Schwab, Prof., Principal investigator, Dr. Margarete Fischer-Bosch-Institute of Clinical Pharmacology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01289756
- Sponsor's protocol ID
- IKP237
- Other IDs
- 2009-014531-20, 2009
- Status last verified
- Feb 2015
- First submitted
- 2 Feb 2011
- Last updated
- 24 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Pharmacogenetic Factors, Paroxetine and Clarithromycin on Pharmacokinetics of Clomiphene
- ClinicalTrials.gov ID
- NCT01289756
- Acronym / sponsor ID
- IKP237
- Conditions
- Anovulation, Disorder Due Cytochrome P450 CYP2D6 Variant, Cytochrome P450 CYP3A Enzyme Deficiency
- Keywords
- pharmacokinetic, clomiphene, CYP2D6 polymorphisms, inhibition of CYP2D6 and CYP3A4
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Robert Bosch Gesellschaft für Medizinische Forschung mbH (RBMF)University, hospital or other
- Study start
- Dec 2009
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 4 Feb 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Aim of the study is the clinical validation of the metabolism and the pharmakokinetic of Clomifen in correlation to CYP2D6 and inhibition of CYP3A4.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| CYP2D6 EM | Experimental | Drug: Clomiphene, Drug: clomiphene and paroxetine, Drug: clomiphene and clarithromycinclomiphene, clomiphene and paroxetine, clomiphene and clarithromycin |
| CYP2D6 IM | Experimental | Drug: Clomiphene, Drug: clomiphene and paroxetine, Drug: clomiphene and clarithromycinclomiphene, clomiphene and paroxetine, clomiphene and clarithromycin |
| CYP2D6 PM | Experimental | Drug: Clomiphene, Drug: clomiphene and paroxetine, Drug: clomiphene and clarithromycinclomiphene, clomiphene and paroxetine, clomiphene and clarithromycin |
| CYP2D6 UM | Experimental | Drug: Clomiphene, Drug: clomiphene and paroxetine, Drug: clomiphene and clarithromycinclomiphene, clomiphene and paroxetine, clomiphene and clarithromycin |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy
- Female caucasians
- Age 18 - 45 years old
- BMI 18.5 - 26 kg/m2
Key exclusion criteria (4 listed)
- Persons with known sensitivity of Clomifen and/or Paroxetine and/or Clarithromycin
- Pregnancy/lactation period
- Meno-/postmenopausal
- Smokers
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clomipheneclomiphene once 100 mg oral | Drug | CYP2D6 EM, CYP2D6 IM, CYP2D6 PM, CYP2D6 UM |
| clomiphene and paroxetineclomiphene 100mg and paroxetine 3x40mg | Drug | CYP2D6 EM, CYP2D6 IM, CYP2D6 PM, CYP2D6 UM |
| clomiphene and clarithromycinclomiphene 100mg and clarithromycin 9x500mg | Drug | CYP2D6 EM, CYP2D6 IM, CYP2D6 PM, CYP2D6 UM |
Primary outcome
Area under the plasma concentration versus time curve (AUC)of clomiphene
Time frame: 1, 2, 4, 6, 8, 10, 12, 24, 72 and 168 hours after durg application
AUC of clomiphene and metabolites
Peak Plasma Concentration (Cmax)of Clomiphene
Time frame: 1, 2, 4, 6, 8, 10, 12, 24, 72 and 168 hours after drug application
Cmax of Clomiphene and metabolites
4 secondary outcomes
Clearance of Clomiphene
Time frame: 4, 8, 12 and 24 hours after drug application
Metabolomic
Time frame: 4, 8, 12 and 24 hours after drug application
Tmax of clomiphene
Time frame: 4, 8, 12, 24 hours after drug application
Pharmacogenomics
Time frame: once
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matthias Schwab, Prof. principal investigator
Dr. Margarete Fischer-Bosch-Institute of Clinical Pharmacology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Clomiphene, clomiphene and paroxetine and clomiphene and clarithromycin in people with Anovulation and Disorder Due Cytochrome P450 CYP2D6 Variant, run by Robert Bosch Gesellschaft für Medizinische Forschung mbH (RBMF) at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area under the plasma concentration versus time curve (AUC)of clomiphene (time frame: 1, 2, 4, 6, 8, 10, 12, 24, 72 and 168 hours after durg application). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2015.