Erectile DysfunctionPhase 4NCT00975325
Bioequivalence Study Comparing Two Test Products With One Reference Product, All Containing 5 mg Yohimbine
A Phase 4 study testing Yohimbine in people with Erectile Dysfunction, run by Walter Ritter GmbH & Co at 1 site in Germany.
Trial summary
Type: Bioequivalence study in male healthy volunteers, therapeutical indication (erectile disfunction) not studied Products, dosage, and route of administration: Test 1: Yohimbin "Spiegel"® (Desma GmbH, Germany), tablet containing 5 mg yohimbine hydrochloride, oral administration Reference: Yocon-Glenwood® (Glenwood… Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Erectile Dysfunction
- What is being tested?
- Yohimbine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2009to Dec 2010
- Phase
- Phase 4
- 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 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Sex: male
- Ethnic origin: Caucasian
- Age: 18 - 55 years, inclusive
- Body-mass index1 (BMI): ≥ 19 kg/m² and ≤ 27 kg/m²
- Good state of health
- Non-smoker or an ex-smoker for a least 1 month
- Written informed consent, after having been informed about benefits and potential risks of the trial, as well as details of the insurance taken out to cover the subjects participating in the study
Who cannot join
- Safety concerns:
- Existing cardiac or haematological diseases and/or pathological findings, which might interfere with the safety, tolerability, absorption and/or pharmacokinetics of the active ingredient
- Existing hepatic and/or renal diseases and/or pathological findings, which might interfere with the safety, tolerability, absorption and/or pharmacokinetics of the active ingredient
- Existing gastrointestinal diseases and/or pathological findings, which might interfere with the safety, tolerability, absorption and/or pharmacokinetics of the active ingredient
- History of relevant CNS and/or psychiatric disorders and/or currently treated CNS and/or psychiatric disorders
- Pathological ECG (12 standard leads) which might interfere with the safety of the active ingredient
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- Known allergic reactions to the active ingredients used or to constituents of the pharmaceutical preparations
- Subjects with severe allergies or multiple drug allergies
- Systolic blood pressure <100/>140 mmHg
- Diastolic blood pressure <60/>90 mmHg
- Pulse rate <45/>110 bpm
- Laboratory values out of normal range unless the deviation from normal is judged as not relevant for the study by the investigator
- Positive anti-HIV-test, HBs-AG-test or anti-HCV-test
- History of glaucoma
- Lack of suitability for the trial 14. Subjects exhibiting extreme genetic polymorphism of CYP 2D6 - "Poor or Ultra-rapid metabolizer" 15. Acute or chronic diseases which could affect absorption or metabolism 16. History of or current drug or alcohol dependence 17. Regular intake of alcoholic food or beverages of ≥ 40 g pure ethanol for male per day 18. Subjects who are on a diet which could affect the pharmacokinetics of the active ingredient 19. Regular intake of caffeine containing food or beverages of ≥ 500 mg per day 20. Blood donation or other blood loss of more than 400 ml within the last two months prior to individual enrolment of the subject 21. Participation in a clinical trial during the last two months prior to individual enrolment of the subject 22. Regular treatment with any systemically available medication (except continuous usual replacement therapy e.g. L-thyroxine) within two weeks prior to the first administration of the study medication 23. Intake of yohimbine for any reason (e.g. fat burning, weight reduction, muscle improvement, post operative care and/or any therapy for erectile dysfunctions) within two weeks prior to first administration of the study medication 24. Subjects, who report a frequent occurrence of migraine attacks
- Administrative reasons 25. Subjects suspected or known not to follow instructions 26. Subjects who are unable to understand the written and verbal instructions, in particular regarding the risks and inconveniences they will be exposed to during their participation in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Characterisation of Relative Bioavailability and Assessment of Bioequivalence of Two Generic Yohimbine Formulations in Comparison With a Marketed Reference Product - an Open, Randomised, Single Dose, 3-period Change-over Study
- Type: Bioequivalence study in male healthy volunteers, therapeutical indication (erectile disfunction) not studied
- Products, dosage, and route of administration:
- Test 1: Yohimbin "Spiegel"® (Desma GmbH, Germany), tablet containing 5 mg yohimbine hydrochloride, oral administration
- Reference: Yocon-Glenwood® (Glenwood GmbH, Germany), tablet containing 5 mg yohimbine hydrochloride, oral administration
- Duration of treatment: 2 single-dose administrations of 5 mg yohimbine hydrochloride each under fasting conditions separated by a wash-out period of at least one week i.e. 6 treatment free days between all administrations
Read the detailed description
Study objectives
Primary Objectives:
- Characterisation of relative bioavailability of Test 1 in comparison to Reference after single dose administration under fasting conditions
- Assessment of bioequivalence of Test 1 vs. Reference after single dose administration under fasting conditions, determined by use of area under the concentration time curve AUC0-tlast and maximal concentration Cmax obtained for yohimbine
Secondary Objective:
- Descriptive characterisation of safety and tolerability of the investigational products in the study population
- Descriptive characterisation of blood pressure and pulse rate around Cmax of the investigational products in the study population
Analytical methodology:
Yohimbine in plasma samples will be analysed by use of a validated HPLC-MS/MS; intended LLOQ for yohimbine is 0.5 ng/ml
- Conditions
- Erectile Dysfunction
- Being tested
- Yohimbine
- Keywords
- Bioequivalency
- Medical subject headings
- Erectile Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YohimbineDrug
yohimbine 5 mg, one tablet, single dose only
YohimbineDrug
yohimbine 5 mg, one tablet, single dose only
| Study group | Role | What they receive |
|---|---|---|
| Yohimbine, Yohimbine "Spiegel" | Active comparator | Not described Receives: Drug: Yohimbine |
| Yohimbine Yocon-Glenwood | Active comparator | Not described Receives: Drug: Yohimbine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic parameter AUC, Cmax
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2009 (estimated)
- Study startOct 2009
- Primary completionMar 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Erectile DysfunctionStudies 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 4
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Walter Ritter GmbH & Co
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Frank Donath, MD, Principal investigator, SocraTec R&D GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00975325
- Sponsor's protocol ID
- YOH-BE-2009
- Other IDs
- EudraCT No.2009-013122-16
- Status last verified
- Jun 2015
- First submitted
- 8 Sep 2009
- Last updated
- 26 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterisation of Relative Bioavailability and Assessment of Bioequivalence of Two Generic Yohimbine Formulations in Comparison With a Marketed Reference Product - an Open, Randomised, Single Dose, 3-period Change-over Study
- ClinicalTrials.gov ID
- NCT00975325
- Acronym / sponsor ID
- YOH-BE-2009
- Conditions
- Erectile Dysfunction
- Keywords
- Bioequivalency
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Walter Ritter GmbH & CoIndustry (pharma, biotech, devices)
- Study start
- Oct 2009
- Primary completion
- Mar 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 11 Sep 2009 (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.
- Type: Bioequivalence study in male healthy volunteers, therapeutical indication (erectile disfunction) not studied
- Products, dosage, and route of administration:
- Test 1: Yohimbin "Spiegel"® (Desma GmbH, Germany), tablet containing 5 mg yohimbine hydrochloride, oral administration
- Reference: Yocon-Glenwood® (Glenwood GmbH, Germany), tablet containing 5 mg yohimbine hydrochloride, oral administration
- Duration of treatment: 2 single-dose administrations of 5 mg yohimbine hydrochloride each under fasting conditions separated by a wash-out period of at least one week i.e. 6 treatment free days between all administrations
Detailed description
Study objectives
Primary Objectives:
- Characterisation of relative bioavailability of Test 1 in comparison to Reference after single dose administration under fasting conditions
- Assessment of bioequivalence of Test 1 vs. Reference after single dose administration under fasting conditions, determined by use of area under the concentration time curve AUC0-tlast and maximal concentration Cmax obtained for yohimbine
Secondary Objective:
- Descriptive characterisation of safety and tolerability of the investigational products in the study population
- Descriptive characterisation of blood pressure and pulse rate around Cmax of the investigational products in the study population
Analytical methodology:
Yohimbine in plasma samples will be analysed by use of a validated HPLC-MS/MS; intended LLOQ for yohimbine is 0.5 ng/ml
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Yohimbine, Yohimbine "Spiegel" | Active comparator | Drug: Yohimbine |
| Yohimbine Yocon-Glenwood | Active comparator | Drug: Yohimbine |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Sex: male
- Ethnic origin: Caucasian
- Age: 18 - 55 years, inclusive
- Body-mass index1 (BMI): ≥ 19 kg/m² and ≤ 27 kg/m²
- Good state of health
Key exclusion criteria (16 listed)
- Safety concerns:
- Lack of suitability for the trial 14. Subjects exhibiting extreme genetic polymorphism of CYP 2D6 - "Poor or Ultra-rapid metabolizer" 15. Acute or chronic diseases which could affect absorption or metabolism 16. History of or current drug or alcohol dependence 17. Regular intake of alcoholic food or beverages of ≥ 40 g pure ethanol for male per day 18. Subjects who are on a diet which could affect the pharmacokinetics of the active ingredient 19. Regular intake of caffeine containing food or beverages of ≥ 500 mg per day 20. Blood donation or other blood loss of more than 400 ml within the last two months prior to individual enrolment of the subject 21. Participation in a clinical trial during the last two months prior to individual enrolment of the subject 22. Regular treatment with any systemically available medication (except continuous usual replacement therapy e.g. L-thyroxine) within two weeks prior to the first administration of the study medication 23. Intake of yohimbine for any reason (e.g. fat burning, weight reduction, muscle improvement, post operative care and/or any therapy for erectile dysfunctions) within two weeks prior to first administration of the study medication 24. Subjects, who report a frequent occurrence of migraine attacks
- Administrative reasons 25. Subjects suspected or known not to follow instructions 26. Subjects who are unable to understand the written and verbal instructions, in particular regarding the risks and inconveniences they will be exposed to during their participation in the study
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 |
|---|---|---|
| Yohimbineyohimbine 5 mg, one tablet, single dose only | Drug | Yohimbine, Yohimbine "Spiegel" |
| Yohimbineyohimbine 5 mg, one tablet, single dose only | Drug | Yohimbine Yocon-Glenwood |
Primary outcome
Pharmacokinetic parameter AUC, Cmax
Time frame: Day 1
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 26 Jun 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.
Frank Donath, MD principal investigator
SocraTec R&D GmbH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Yohimbine in people with Erectile Dysfunction, run by Walter Ritter GmbH & Co 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 7 inclusion and 16 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 26 Jun 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Pharmacokinetic parameter AUC, Cmax (time frame: Day 1). 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 26 Jun 2015.