HypogonadismPhase 2NCT01386567
A One Year Open Label Study for the Treatment of Hypogonadism (Low Testosterone) in Men Who Have Completed ZA-203
A Phase 2 study testing Androxal (enclomiphene citrate) and Testim (topical testosterone) in people with Hypogonadism and Low Testosterone, run by Repros Therapeutics Inc. at 8 sites in United States.
Trial summary
The purpose of this study is to determine the continued effects of Androxal on morning testosterone and reproductive status in men with secondary hypogonadism who have completed protocol ZA-203. Read more about this study
- Who is it for?
- Ages 21 to 65 years, men only
- Conditions the study is for
- Hypogonadism, Low Testosterone
- What is being tested?
- Androxal (enclomiphene citrate) and Testim (topical testosterone)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 8 sitesUnited States
- Study dates
- Jul 2011to Jan 2013
- Phase
- Phase 2
- 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 21 to 65 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Successful completion of ZA-203
- Ability to understand and provide written informed consent
- Agreement to use a condom, and with a fertile female partner, another form of contraception
- Agreement to provide semen samples in the clinic
Who cannot join
- Any condition which, in the opinion of the Investigator, would make the Subject an unsuitable candidate for enrollment in the study
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Study site
Garden Grove, California, 92844
Study site
Houston, Texas, 77024
Study site
Houston, Texas, 77062
Study site
Houston, Texas, 77095
Study site
Las Vegas, Nevada, 89109
Study site
Las Vegas, Nevada, 89144
Study site
Sacramento, California, 95821
Study site
San Diego, California, 92108
About this study
Official title: A One Year Open Label Study of Androxal in the Treatment of Secondary Hypogonadism in Men Who Have Completed Protocol ZA-203
The purpose of this study is to determine the continued effects of Androxal on morning testosterone and reproductive status in men with secondary hypogonadism who have completed protocol ZA-203. Men will be allowed to choose Androxal (enclomiphene citrate) or Testim (topical testosterone) at the beginning of the study. All men on Androxal will start at 12.5 mg and will be allowed to up titrate to 25 mg if an inadequate response is exhibited at the lower dose.
- Conditions
- Hypogonadism, Low Testosterone
- Being tested
- Androxal (enclomiphene citrate), Testim (topical testosterone)
- Keywords
- hypogonadism, low testosterone, low T
- Medical subject headings
- Hypogonadism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Androxal (enclomiphene citrate)Drug
Also called enclomiphene citrate
capsules oral 1x a day
1 year
Testim (topical testosterone)Drug
Also called topical testosterone, exogenous testosterone, testosterone gel
topical
1 tube
1x a day
1 year
| Study group | Role | What they receive |
|---|---|---|
| Androxal | Experimental | Androxal (enclomiphene citrate)12.5 mg or 25 mg Receives: Drug: Androxal (enclomiphene citrate) |
| Testim (topical testosterone) | Active comparator | Not described Receives: Drug: Testim (topical testosterone) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in testosterone comparing Androxal to Testim
Values of total morning testosterone levels at each visit comparing Androxal (enclomiphene citrate) 12.5 and 25 mg and Testim
Measured: 1 year
Secondary outcomes (2)
Change in leuteinizing hormone and follicle stimulating hormone comparing Androxal (enclomiphene citrate) to Testim (topical testosterone)
Values of follicle stimulating hormone (FSH) and leuteinizing hormone (LH) at each visit comparing Androxal 12.5 and 25 mg to Testim
Measured: 1 year
Changes in sperm parameters from baseline comparing Androxal (enclomiphene citrate) to Testim (topical testosterone)
Reproductive safety will be assessed by changes in values from baseline of semen volume, and sperm concentration, total count, morphology and motility at baseline (Visit 1), month 4, 6 and 12 comparing Androxal 12.5 and 25 mg to Testim
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2011 (estimated)
- Study startJul 2011
- Primary completionJan 2013
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 48 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
- NCT01386567
- Sponsor's protocol ID
- ZA-203 Extension
- Status last verified
- May 2013
- First submitted
- 29 Jun 2011
- Last updated
- 17 May 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A One Year Open Label Study of Androxal in the Treatment of Secondary Hypogonadism in Men Who Have Completed Protocol ZA-203
- ClinicalTrials.gov ID
- NCT01386567
- Acronym / sponsor ID
- ZA-203 Extension
- Conditions
- Hypogonadism, Low Testosterone
- Keywords
- hypogonadism, low testosterone, low T
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Repros Therapeutics Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 2011
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 1 Jul 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.
The purpose of this study is to determine the continued effects of Androxal on morning testosterone and reproductive status in men with secondary hypogonadism who have completed protocol ZA-203. Men will be allowed to choose Androxal (enclomiphene citrate) or Testim (topical testosterone) at the beginning of the study. All men on Androxal will start at 12.5 mg and will be allowed to up titrate to 25 mg if an inadequate response is exhibited at the lower dose.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Androxal | Experimental | Drug: Androxal (enclomiphene citrate)Androxal (enclomiphene citrate)12.5 mg or 25 mg |
| Testim (topical testosterone) | Active comparator | Drug: Testim (topical testosterone) |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Successful completion of ZA-203
- Ability to understand and provide written informed consent
- Agreement to use a condom, and with a fertile female partner, another form of contraception
- Agreement to provide semen samples in the clinic
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 |
|---|---|---|
| Androxal (enclomiphene citrate)Also: enclomiphene citratecapsules oral 1x a day 1 year | Drug | Androxal |
| Testim (topical testosterone)Also: topical testosterone, exogenous testosterone, testosterone geltopical 1 tube 1x a day 1 year | Drug | Testim (topical testosterone) |
Primary outcome
Change in testosterone comparing Androxal to Testim
Time frame: 1 year
Values of total morning testosterone levels at each visit comparing Androxal (enclomiphene citrate) 12.5 and 25 mg and Testim
2 secondary outcomes
Change in leuteinizing hormone and follicle stimulating hormone comparing Androxal (enclomiphene citrate) to Testim (topical testosterone)
Time frame: 1 year
Changes in sperm parameters from baseline comparing Androxal (enclomiphene citrate) to Testim (topical testosterone)
Time frame: 1 year
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 17 May 2013.
- Sponsor websiteLink provided by the sponsor.
- Study informationLink provided by the sponsor.
Related trials for Hypogonadism
RecruitingObservational study
Inherited Reproductive Disorders
Genetic Disorder, Infertility
RecruitingPhase 2
Clinical Trial to Observe the Effects of Tamoxifen on Testosterone Recovery in Medically Castrated Prostate Cancer Patients
Hypogonadism, Prostate Cancer
Not yet recruitingPhase 2
HRT-PC Trial: Hormone Recovery After Treatment for Prostate Cancer Trial. An Open-label Phase II Study of Clomiphene Citrate in Patients With Persistent Hypogonadism After ADT for Treatment of Localized Prostate Cancer
Prostate Cancer
Active, not recruitingPhase 2
Efficacy and Safety of Phentermine/Topiramate in Youth With Hypothalamic Obesity
Hypothalamic Obesity, Hypothalamic Tumor
Active, not recruitingPhase 1/2
A Study of RM-718 in Healthy Subjects and Patients With MC4R Pathway Impairment
Hypothalamic Obesity, Prader-Willi Syndrome
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.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Androxal (enclomiphene citrate) and Testim (topical testosterone) in people with Hypogonadism and Low Testosterone, run by Repros Therapeutics Inc. at 8 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 4 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 17 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Change in testosterone comparing Androxal to Testim (time frame: 1 year). 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 17 May 2013.