Secondary HypogonadismPhase 3NCT01993225
A Randomized, Double Blind, Placebo-Controlled, Multi-Center Phase III Study in Men With Acquired Hypogonadotropic Hypogonadism to Compare Changes in Testosterone and Sperm Concentration Following Treatment With 12.5 mg or 25 mg Androxal or AndroGel 1.62%
A Phase 3 study testing Androxal 12.5 mg/25 mg and AndroGel 1.62% in people with Secondary Hypogonadism, run by Repros Therapeutics Inc. at 9 sites in United States.
Trial summary
This is a Randomized, Double Blind, Placebo-Controlled, Multi-Center Phase III Study in Men with Acquired Hypogonadotropic Hypogonadism to Compare Changes in Testosterone and Sperm Concentration Following Treatment with 12.5 mg or 25 mg Androxal or AndroGel 1.62%. Read more about this study
- Who is it for?
- Ages 18 to 60 years, men only
- Conditions the study is for
- Secondary Hypogonadism
- What is being tested?
- Androxal 12.5 mg/25 mg and AndroGel 1.62%
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 9 sitesUnited States
- Study dates
- Jan 2014to Aug 2014
- Phase
- Phase 3
- 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 60 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Overweight (BMI 25 to 42 kg/m2 inclusive) males age 18 to 60 inclusive
- Previously or concurrently diagnosed as having secondary hypogonadism characterized as having at least 2 consecutive morning testosterone assessments < 300ng/dL, one of which must be confirmed at Baseline.
- LH < 9.4 mIU/mL (at Visit 1 only)
- Sperm concentration ≥ 15 million per milliliter (assessed at V2 and Baseline). V2 and Baseline measurements must be at least 48 hours apart.
- Ability to complete the study in compliance with the protocol
- Ability to understand and provide written informed consent
- Agreement to provide a total of at least 4 semen samples in a sponsor-approved clinic on 4 separate occasions.
Who cannot join
- Any prior use of testosterone treatments (injectable, pelleted, transdermal or sublingual) within the last 6 months
- Use of spironolactone, cimetidine, Clomid, 5α-reductase inhibitors, hCG, androgen, estrogen, anabolic steroid, DHEA, or herbal hormone products during the study
- Use of Clomid in the past year
- Any clinically significant laboratory abnormality that does not have prior written sponsor approval. If the sponsor approves subject enrollment, this will not be considered to be a protocol deviation.
- Uncontrolled hypertension or diabetes mellitus based on the Investigator's assessment at baseline. Subjects treated for Type II diabetes will be allowed into the study, if considered clinically stable by the investigator. Newly diagnosed diabetics need to be treated for at least 48 hours before being enrolled in the study.
- A hematocrit >54
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- Use of an investigational drug or product, or participation in a drug or medical device research study within 30 days prior to receiving study medication.
- Known hypersensitivity to Clomid
- Symptomatic cataracts (nuclear sclerosis cataract or cortical cataract grade > 2 based on 0-4 scale or any evidence of posterior subcapsular cataract)
- Abnormal fundoscopy exam such as central retinal vein occlusion
- Any condition which in the opinion of the investigator would interfere with the participant's ability to provide informed consent, comply with study instructions, possibly confound interpretation of study results, or endanger the participant if he took part in the study
- Have received a diagnosis of irreversible infertility or compromised fertility (cryptorchism, Kallman Syndrome, primary hypogonadism, vasectomy, or tumors of the pituitary), or history of evaluation or treatment for low fertility
- Current or history of breast cancer
- Current or history of prostate cancer or a suspicion of prostate disease unless ruled out by prostate biopsy, or a PSA>3.6
- Presence or history of known hyperprolactinemia with or without a tumor (prolactin > 20 ng/mL).
- Chronic use of medications such as glucocorticoids (chronic use of inhaled or topical glucocorticoids is acceptable)
- History of drug abuse or chronic narcotic use including methadone
- A recent history of alcoholism or illegal substance or steroid abuse (<2 years) or presence of moderate alcohol use (>21 drinks per week)
- Subjects with known history of HIV and/or Hepatitis C
- Subjects with end stage renal disease
- History of liver disease (including malignancy) or a confirmed AST or ALT >3 times the upper limit of normal
- History of clinically relevant myocardial infarction (within the previous year), unstable angina, symptomatic heart failure, ventricular dysrhythmia or know history of QTc interval prolongation
- History of clinically relevant cerebrovascular disease
- History of venous thromboembolic disease (e.g. deep vein thrombosis or pulmonary embolism)
- History of erythrocytosis or polycythemia
- Subjects unable to provide a semen sample in a sponsor-approved clinic
- Enrollment in a previous Androxal study
- Subjects who have Type I Diabetes
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Study site
Birmingham, Alabama
Study site
Evanston, Illinois
Study site
Garden City, New York
Study site
Lexington, Kentucky
Study site
Mobile, Alabama
Study site
Nashville, Tennessee
Study site
New York, New York
Study site
Riverton, Utah
Study site
Rochester, New York
About this study
This is a Randomized, Double Blind, Placebo-Controlled, Multi-Center Phase III Study in Men with Acquired Hypogonadotropic Hypogonadism to Compare Changes in Testosterone and Sperm Concentration Following Treatment with 12.5 mg or 25 mg Androxal or AndroGel 1.62%.
- Conditions
- Secondary Hypogonadism
- Being tested
- Androxal 12.5 mg/25 mg, Placebo Capsules, AndroGel 1.62%, Placebo Gel
- Keywords
- Low Testosterone
- Medical subject headings
- Hypogonadism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Androxal 12.5 mg/25 mgDrug
Placebo CapsulesDrug
AndroGel 1.62%Drug
Placebo GelDrug
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo Gel and Placebo capsules Receives: Drug: Placebo Capsules; Drug: Placebo Gel |
| Androxal Treatment | Experimental | Androxal 12.5mg/25 mg and Placebo gel Receives: Drug: Androxal 12.5 mg/25 mg; Drug: Placebo Gel |
| AndroGel Treatment | Active comparator | AndroGel 1.62% and Placebo Capsules Receives: Drug: Placebo Capsules; Drug: AndroGel 1.62% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of the proportion of subjects who meet the composite endpoint of normal 24-hour average testosterone and sperm concentration.
Comparison of the proportion of subjects whose 24-hour average testosterone levels are within the normal range [300-1,040 ng/dL] and whose sperm concentration is 15 million/mL or greater following 16 weeks of treatment with Androxal, placebo or AndroGel 1.62%.
Measured: 16 weeks of treatment
Secondary outcomes (1)
Proportion of subjects with mean sperm concentration less than 15 million/mL after 16 weeks of treatment comparing Androxal to placebo in a non-inferiority assessment
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2013 (estimated)
- Study startJan 2014
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 120 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
- NCT01993225
- Sponsor's protocol ID
- ZA-305
- Status last verified
- Sep 2014
- First submitted
- 13 Nov 2013
- Last updated
- 1 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double Blind, Placebo-Controlled, Multi-Center Phase III Study in Men With Acquired Hypogonadotropic Hypogonadism to Compare Changes in Testosterone and Sperm Concentration Following Treatment With 12.5 mg or 25 mg Androxal or AndroGel 1.62%
- ClinicalTrials.gov ID
- NCT01993225
- Acronym / sponsor ID
- ZA-305
- Conditions
- Secondary Hypogonadism
- Keywords
- Low Testosterone
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Repros Therapeutics Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2014
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 25 Nov 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.
This is a Randomized, Double Blind, Placebo-Controlled, Multi-Center Phase III Study in Men with Acquired Hypogonadotropic Hypogonadism to Compare Changes in Testosterone and Sperm Concentration Following Treatment with 12.5 mg or 25 mg Androxal or AndroGel 1.62%.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo Capsules, Drug: Placebo GelPlacebo Gel and Placebo capsules |
| Androxal Treatment | Experimental | Drug: Androxal 12.5 mg/25 mg, Drug: Placebo GelAndroxal 12.5mg/25 mg and Placebo gel |
| AndroGel Treatment | Active comparator | Drug: Placebo Capsules, Drug: AndroGel 1.62%AndroGel 1.62% and Placebo Capsules |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Overweight (BMI 25 to 42 kg/m2 inclusive) males age 18 to 60 inclusive
- Previously or concurrently diagnosed as having secondary hypogonadism characterized as having at least 2 consecutive morning testosterone assessments < 300ng/dL, one of which must be confirmed at Baseline.
- LH < 9.4 mIU/mL (at Visit 1 only)
- Sperm concentration ≥ 15 million per milliliter (assessed at V2 and Baseline). V2 and Baseline measurements must be at least 48 hours apart.
- Ability to complete the study in compliance with the protocol
Key exclusion criteria (28 listed)
- Any prior use of testosterone treatments (injectable, pelleted, transdermal or sublingual) within the last 6 months
- Use of spironolactone, cimetidine, Clomid, 5α-reductase inhibitors, hCG, androgen, estrogen, anabolic steroid, DHEA, or herbal hormone products during the study
- Use of Clomid in the past year
- Any clinically significant laboratory abnormality that does not have prior written sponsor approval. If the sponsor approves subject enrollment, this will not be considered to be a protocol deviation.
- Uncontrolled hypertension or diabetes mellitus based on the Investigator's assessment at baseline. Subjects treated for Type II diabetes will be allowed into the study, if considered clinically stable by the investigator. Newly diagnosed diabetics need to be treated for at least 48 hours before being enrolled 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 |
|---|---|---|
| Androxal 12.5 mg/25 mg | Drug | Androxal Treatment |
| Placebo Capsules | Drug | AndroGel Treatment, Placebo |
| AndroGel 1.62% | Drug | AndroGel Treatment |
| Placebo Gel | Drug | Androxal Treatment, Placebo |
Primary outcome
Comparison of the proportion of subjects who meet the composite endpoint of normal 24-hour average testosterone and sperm concentration.
Time frame: 16 weeks of treatment
Comparison of the proportion of subjects whose 24-hour average testosterone levels are within the normal range [300-1,040 ng/dL] and whose sperm concentration is 15 million/mL or greater following 16 weeks of treatment with Androxal, placebo or AndroGel 1.62%.
1 secondary outcome
Proportion of subjects with mean sperm concentration less than 15 million/mL after 16 weeks of treatment comparing Androxal to placebo in a non-inferiority assessment
Time frame: 16 weeks
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 1 Oct 2014.
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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.
The record lists no contact. Use the official record to reach the sponsor.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Androxal 12.5 mg/25 mg and AndroGel 1.62% in people with Secondary Hypogonadism, run by Repros Therapeutics Inc. at 9 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 7 inclusion and 28 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 1 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Comparison of the proportion of subjects who meet the composite endpoint of normal 24-hour average testosterone and sperm concentration. (time frame: 16 weeks of treatment). 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 1 Oct 2014.