Secondary HypogonadismPhase 1NCT01923857
Evaluation of Pharmacokinetic and Safety Profile of Androxal in Male Subjects With Impaired Renal Function
A Phase 1 study testing Androxal 25 mg in people with Secondary Hypogonadism, run by Repros Therapeutics Inc. at 2 sites in United States.
Trial summary
To determine and compare the pharmacokinetics (PK) of a single dose of 25 mg Androxal in overweight male subjects with various stages of renal impairment and in volunteers with normal renal function. Read more about this study
- Who is it for?
- Ages 18 to 80 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Secondary Hypogonadism
- What is being tested?
- Androxal 25 mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 2 sitesUnited States
- Study dates
- Aug 2013to Aug 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 80 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects with Impaired Renal Function:
- Subjects with various stages of impaired renal function must meet all of the following inclusion criteria at screening will be considered for admission to the study:
- Speak, read, and understand English or Spanish and is willing and able to provide written informed consent on an Institutional Review Board (IRB)-approved form prior to the initiation of any study procedures;
- Male, between the ages of 18 and 80 years with Body Mass Index (BMI) between 25 and 42, inclusive, are preferred.
- Subjects must meet the criteria of mildly (creatinine clearance 50-80 mL/min) or moderately (creatinine clearance 30-50 mL/min) impaired renal function. The Investigator will assess the renal impairment category of each subject. Substantiation for the diagnosis must be indicated in source documents; (See Appendix B)
- Subjects must have evidence of stable renal impairment as determined by the Investigator (See Section 9.3.2, Day -1)
Show all 21Show fewer
- If on medications for treatment of the complications of renal disease, and other concomitant chronic illnesses, subjects must have been taking the medications at a stable dose for at least 10 days prior to the first Androxal dosing date and are then to be continued at the same dose for the duration of the study. The medications must be recorded in source documents;
- Subject is willing to remain in the clinic for the screening visit (approximately 1 day for the screening visit) and for the treatment visit (approximately 3 days);
- Non-smokers are preferred, but as this is a very restricted population light to moderate smoking will be allowed (no more than 10 cigarettes/day);
- Must be able to swallow gelatin capsules;
- Subjects with Normal Renal Function:
- Healthy volunteers meeting all of the following inclusion criteria at screening will be considered for admission to the study:
- Speak, read, and understand English or Spanish and is willing and able to provide written informed consent on an IRB-approved form prior to the initiation of any study procedures;
- Male, between the ages of 18 and 60 years with Body Mass Index (BMI) between 25 and 39, inclusive;
- Creatinine clearance > 80 mL/min;
- Subjects in the control group, generally matched for age and BMI to patients enrolled in the test groups: should be ± 20 years of the mean of mildly and moderately renally impaired subjects included in the study and ± 20% of the average BMI of mildly and moderately renally impaired subjects;
- No significant abnormal findings at the screening physical examination as evaluated by the Investigator;
- Normal laboratory values or clinically insignificant findings at screening as determined by the Investigator;
- Subject is willing to remain in the clinic for the screening visit (approximately 1 day for the first screening visit) and for the treatment visit (approximately 3 days);
- No tobacco (nicotine products) use for at least three (3) months prior to the study;
- Must be able to swallow gelatin capsules
Who cannot join
- Subjects with Impaired Renal Function
- Subjects with various stages of impaired renal function meeting any of the following exclusion criteria at screening will not be enrolled in the study:
- Known hypersensitivity to Clomid;
- Subjects with clinically significant abnormal liver function as determined by the Investigator;
- Subjects who are treated with dialysis;
- A physical illness within three (3) months of the study that would interfere with the study as determined by the Investigator;
Show all 35Show fewer
- Participation in a clinical trial with investigational medication within four (4) weeks prior to study medication administration;
- A hematocrit >54% or a hemoglobin >17 g/dL. (Sponsor may approve enrollment of subjects with hemoglobin up to 17.5 g/dL if the subject is at a location with high elevation).
- An acute illness within five (5) days of study medication administration;
- Uncontrolled hypertension based on the Investigator's assessment at baseline. Subjects treated for Type II diabetes will be allowed into the study. Newly diagnosed diabetics need to be treated for at least 48 hours before being enrolled into the study.
- Positive urine drug or infectious disease screen at the screening visit based on laboratory testing;
- A mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study and/or evidence of an uncooperative attitude, as determined by the Investigator;
- History of venous thromboembolic disease (e.g. deep vein thrombosis or pulmonary embolism);
- History of myocardial infarction, unstable angina, symptomatic heart failure, ventricular dysrhythmia, or known history of corrected QT interval (QTc) interval prolongation;
- The use of prohibited concomitant medications:
- Drugs that may interfere with cytochrome P450 2D6 (CYP2D6) activity must cease for 7 days prior to first dose of study drug;
- An employee or family member of an employee of the study site or the Sponsor.
- Subjects with Normal Renal Function:
- Healthy volunteers meeting any of the following exclusion criteria at screening will not be enrolled in the study:
- Known hypersensitivity to Clomid;
- Abnormal screening visit vital signs or clinical laboratory evaluation considered clinically significant by the Investigator;
- Subjects with clinically significant abnormal liver function as determined by the Investigator;
- Subject with a significant organ abnormality or disease as determined by the Investigator;
- A physical illness within three (3) months of the study that would interfere with the study as determined by the Investigator;
- Uncontrolled hypertension based on the Investigator's assessment at baseline. Subjects treated for Type II diabetes will be allowed into the study. Newly diagnosed diabetics need to be treated for at least 48 hours before being enrolled into the study.
- A hematocrit >54% or a hemoglobin >17 g/dL. (Sponsor may approve enrollment of subjects with hemoglobin up to 17.5 g/dL if the subject is at a location with high elevation).
- Participation in a clinical trial with investigational medication within four (4) weeks prior to study medication administration;
- An acute illness within five (5) days of study medication administration;
- A mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study and/or evidence of an uncooperative attitude, as determined by the Investigator;
- History of venous thromboembolic disease (e.g. deep vein thrombosis or pulmonary embolism);
- History of myocardial infarction, unstable angina, symptomatic heart failure, ventricular dysrhythmia, or known history of QTc interval prolongation;
- The use of prohibited concomitant medications:
- Drugs that may interfere with CYP2D6 activity must cease for 7 days prior to first dose of study drug;
- An employee or family member of an employee of the study site or the Sponsor.
- Positive urine drug or infectious disease screen at the screening visit based on laboratory testing;
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Study site
Miami, Florida, 33014
Study site
Minneapolis, Minnesota, 55404
About this study
Official title: A Single-Dose, Open-Label Study to Evaluate the Pharmacokinetics and Safety Profile of Androxal in Male Subjects With Impaired Renal Function
- To determine and compare the pharmacokinetics (PK) of a single dose of 25 mg Androxal in overweight male subjects with various stages of renal impairment and in volunteers with normal renal function.
- To compare the safety profile of a single dose of 25 mg Androxal in overweight male subjects with various stages of renal impairment and in volunteers with normal renal function.
- Conditions
- Secondary Hypogonadism
- Being tested
- Androxal 25 mg
- Medical subject headings
- Hypogonadism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Androxal 25 mgDrug
Also called enclomiphene citrate
| Study group | Role | What they receive |
|---|---|---|
| Healthy Volunteers | Experimental | Healthy males age 18-80 with a body mass index(BMI) 25-42 mg/m^2. Receives: Drug: Androxal 25 mg |
| Mild Renal Impairment | Experimental | Males with mild renal impairment age 18-80 with a body mass index(BMI) 25-42 mg/m^2 (creatinine clearance 50-80 mL/min). Receives: Drug: Androxal 25 mg |
| Moderate Renal Impairment | Experimental | Males with moderate renal impairment age 18-80 with a body mass index(BMI) 25-42 mg/m^2 (creatinine clearance 30-50 mL/min). Receives: Drug: Androxal 25 mg |
| Severe renal impairment | Experimental | Not described Receives: Drug: Androxal 25 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic parameters
Pharmacokinetic parameters calculated as a ratio in subjects with mild or moderate renal impairment to normal after a single dose of 25 mg Androxal.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2013 (estimated)
- Study startAug 2013
- Primary completionAug 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Secondary HypogonadismStudies 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Repros Therapeutics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01923857
- Sponsor's protocol ID
- ZA-104
- Status last verified
- Aug 2014
- First submitted
- 13 Aug 2013
- Last updated
- 11 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Dose, Open-Label Study to Evaluate the Pharmacokinetics and Safety Profile of Androxal in Male Subjects With Impaired Renal Function
- ClinicalTrials.gov ID
- NCT01923857
- Acronym / sponsor ID
- ZA-104
- Conditions
- Secondary Hypogonadism
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Repros Therapeutics Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2013
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 16 Aug 2013 (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.
- To determine and compare the pharmacokinetics (PK) of a single dose of 25 mg Androxal in overweight male subjects with various stages of renal impairment and in volunteers with normal renal function.
- To compare the safety profile of a single dose of 25 mg Androxal in overweight male subjects with various stages of renal impairment and in volunteers with normal renal function.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Healthy Volunteers | Experimental | Drug: Androxal 25 mgHealthy males age 18-80 with a body mass index(BMI) 25-42 mg/m^2. |
| Mild Renal Impairment | Experimental | Drug: Androxal 25 mgMales with mild renal impairment age 18-80 with a body mass index(BMI) 25-42 mg/m^2 (creatinine clearance 50-80 mL/min). |
| Moderate Renal Impairment | Experimental | Drug: Androxal 25 mgMales with moderate renal impairment age 18-80 with a body mass index(BMI) 25-42 mg/m^2 (creatinine clearance 30-50 mL/min). |
| Severe renal impairment | Experimental | Drug: Androxal 25 mg |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- Subjects with various stages of impaired renal function must meet all of the following inclusion criteria at screening will be considered for admission to the study:
- Speak, read, and understand English or Spanish and is willing and able to provide written informed consent on an Institutional Review Board (IRB)-approved form prior to the initiation of any study procedures;
- Male, between the ages of 18 and 80 years with Body Mass Index (BMI) between 25 and 42, inclusive, are preferred.
- Subjects must meet the criteria of mildly (creatinine clearance 50-80 mL/min) or moderately (creatinine clearance 30-50 mL/min) impaired renal function. The Investigator will assess the renal impairment category of each subject. Substantiation for the diagnosis must be indicated in source documents; (See Appendix B)
- Subjects must have evidence of stable renal impairment as determined by the Investigator (See Section 9.3.2, Day -1)
Key exclusion criteria (35 listed)
- Subjects with Impaired Renal Function
- Subjects with various stages of impaired renal function meeting any of the following exclusion criteria at screening will not be enrolled in the study:
- Known hypersensitivity to Clomid;
- Subjects with clinically significant abnormal liver function as determined by the Investigator;
- Subjects who are treated with dialysis;
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 |
|---|---|---|
| Androxal 25 mgAlso: enclomiphene citrate | Drug | Healthy Volunteers, Mild Renal Impairment, Moderate Renal Impairment, Severe renal impairment |
Primary outcome
Pharmacokinetic parameters
Time frame: 24 hours
Pharmacokinetic parameters calculated as a ratio in subjects with mild or moderate renal impairment to normal after a single dose of 25 mg Androxal.
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 11 Aug 2014.
- Sponsor Web SiteLink provided by the sponsor.
Related trials for Secondary Hypogonadism
Enrolling by invitation
AIM-TEST: Microbiome-Targeted Nutrition for Functional Secondary Hypogonadism
Hypogonadism, Male, Secondary Hypogonadism
Not yet recruiting
Intratesticular Artery Resistive Index Changes After Varicocelectomy
Varicocele, Male Infertility
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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Androxal 25 mg in people with Secondary Hypogonadism, run by Repros Therapeutics Inc. at 2 sites in United States.
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 21 inclusion and 35 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 11 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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?
Pharmacokinetic parameters (time frame: 24 hours). 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 11 Aug 2014.