Secondary HypogonadismPhase 3NCT01739582
An Extension Study of Enclomiphene Citrate in the Treatment of Men With Secondary Hypogonadism
A Phase 3 study testing Androxal in people with Secondary Hypogonadism, run by Repros Therapeutics Inc..
Trial summary
To determine the safety profile of Androxal in men with secondary hypogonadism. 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
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- Nov 2012to Apr 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
- Successful completion of either ZA-301 or ZA-302
Who cannot join
- Any condition which, in the opinion of the Investigator, would make the Subject an unsuitable candidate for enrollment in the study
About this study
Official title: An Open Label, 6 Month Phase III Extension Study of Enclomiphene Citrate in the Treatment of Men With Secondary Hypogonadism
To determine the safety profile of Androxal in men with secondary hypogonadism.
Read the detailed description
This study is an open-label, multi-center Phase 3 extension study to evaluate the safety on continued treatment with Androxal in subjects who completed either ZA-301 or ZA-302. The study requires 6 study visits (1 for an eye exam) and is approximately 7 months in duration. Subjects will be treated for 26 weeks, starting at a daily dose of 12.5 mg. At Visit 2 (Week 6) subjects who do not achieve morning T values ≥450 ng/dL will be up-titrated to 25 mg. Safety will be assessed by physical and visual acuity exams, slit lamp and fundoscopy, refraction eye exams, clinical laboratory tests and adverse event reporting.
- Conditions
- Secondary Hypogonadism
- Being tested
- Androxal
- Medical subject headings
- Hypogonadism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AndroxalDrug
Also called enclomiphene citrate
| Study group | Role | What they receive |
|---|---|---|
| Androxal | Experimental | Androxal (enclomiphene citrate) 12.5 mg, once daily, oral capsule. Subjects will be up-titrated to 25 mg if testosterone levels remain below 450 ng/dL at visit 2. Receives: Drug: Androxal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Testosterone levels
Values of total morning testosterone levels at each visit
Measured: 26 weeks
Secondary outcomes (3)
Follicle Stimulating Hormone and Leutinizing Hormone
Values of Follicle Stimulating Hormone (FSH) and Leutinizing Hormone (LH) at each visit
Measured: 26 weeks
Diabetic Parameters
Changes in HbA1c, fasting plasma glucose (FPG), insulin, and homeostasis model assessment-insulin resistance (HOMA-IR) for those subjects with Type II diabetes
Measured: 26 weeks
Change in weight and body mass index (BMI)
Change in weight and BMI
Measured: 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2012 (estimated)
- Study startNov 2012
- Primary completionApr 2014
- Study completionApr 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Repros Therapeutics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01739582
- Sponsor's protocol ID
- ZA-301EXT
- Status last verified
- Apr 2014
- First submitted
- 29 Nov 2012
- Last updated
- 16 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, 6 Month Phase III Extension Study of Enclomiphene Citrate in the Treatment of Men With Secondary Hypogonadism
- ClinicalTrials.gov ID
- NCT01739582
- Acronym / sponsor ID
- ZA-301EXT
- Conditions
- Secondary Hypogonadism
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Repros Therapeutics Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2012
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 3 Dec 2012 (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 the safety profile of Androxal in men with secondary hypogonadism.
Detailed description
This study is an open-label, multi-center Phase 3 extension study to evaluate the safety on continued treatment with Androxal in subjects who completed either ZA-301 or ZA-302. The study requires 6 study visits (1 for an eye exam) and is approximately 7 months in duration. Subjects will be treated for 26 weeks, starting at a daily dose of 12.5 mg. At Visit 2 (Week 6) subjects who do not achieve morning T values ≥450 ng/dL will be up-titrated to 25 mg. Safety will be assessed by physical and visual acuity exams, slit lamp and fundoscopy, refraction eye exams, clinical laboratory tests and adverse event reporting.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Androxal | Experimental | Drug: AndroxalAndroxal (enclomiphene citrate) 12.5 mg, once daily, oral capsule. Subjects will be up-titrated to 25 mg if testosterone levels remain below 450 ng/dL at visit 2. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Successful completion of either ZA-301 or ZA-302
Key exclusion criteria (1 listed)
- Any condition which, in the opinion of the Investigator, would make the Subject an unsuitable candidate for enrollment 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 |
|---|---|---|
| AndroxalAlso: enclomiphene citrate | Drug | Androxal |
Primary outcome
Testosterone levels
Time frame: 26 weeks
Values of total morning testosterone levels at each visit
3 secondary outcomes
Follicle Stimulating Hormone and Leutinizing Hormone
Time frame: 26 weeks
Diabetic Parameters
Time frame: 26 weeks
Change in weight and body mass index (BMI)
Time frame: 26 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 16 Apr 2014.
- Sponsor corporate web pageLink provided by the sponsor.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Androxal in people with Secondary Hypogonadism, run by Repros Therapeutics Inc..
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 1 inclusion and 1 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 16 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
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 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?
Testosterone levels (time frame: 26 weeks). 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 16 Apr 2014.