Secondary HypogonadismPhase 3NCT01534208

Safety 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. at 31 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

ZA-300 is meant to determine the safety profile of Androxal (enclomiphene citrate) in men with secondary hypogonadism. Read more about this study

Who is it for?: Ages 18 to 65 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: 499 participants
Where: 31 sitesUnited States
Study dates: May 2012to Oct 2013
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 65 years
Men only
No healthy volunteers
Adult, Older adult

Who may be able to join

Secondary hypogonadal males between the ages of 18 and 65
Men currently using topical testosterone products should wash-out for at least 7 days before Visit 1.
All clinical laboratory tests within normal ranges (any clinically significant deviation of laboratory results will require approval of sponsor)
Previously or concurrently diagnosed as having secondary hypogonadism and confirmed with morning testosterone level < 350 ng/dL for men age < 55 and < 300ng/dl for men age 55-65
LH < 15mIU/mL (at Visit 1 only)
Ability to complete the study in compliance with the protocol
Ability to understand and provide written informed consent.

Who cannot join

Use of an injectable pelleted testosterone within 6 months prior to study (men currently on topical testosterone products may be enrolled in the study after a 7-day washout period).
Use testosterone injection, 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
Uncontrolled hypertension based on the Investigator's assessment at baseline. Subjects treated for Type II diabetes will be allowed into the study.
A hematocrit ≥ 51% or a hemoglobin ≥ 17 g/dL
Clinically significant abnormal findings on screening examination, based on the Investigator's assessment.

Show all 20Show fewer

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 trace of posterior subcapsular cataract)
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
Irreversibly infertile or compromised fertility (cryptorchism, Kallman Syndrome, primary hypogonadism, or tumors of the pituitary)
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
Chronic use of medications use such as glucocorticoids
Chronic use of narcotics
Subjects know to be positive for HIV
End stage renal disease
Subjects with cystic fibrosis (mutation of the CFTR gene)
Enrollment in a previous Androxal study

Trial locations and contacts

31 sites in 1 country.

City, postcode or hospital

31 sites in 1 country

United States31 sites

Meridien Research
Bradenton, Florida, 34208
Catalina Research Institute
Chino, California, 91710
Florida Fertility Institute
Clearwater, Florida, 33759
Clinical Research Advantage
Colorado Springs, Colorado, 80906
Clinical Research Advantage
Colorado Springs, Colorado, 80922
Lone Peak Family Medicine
Draper, Utah, 84020
Therafirst Medical Center
Fort Lauderdale, Florida, 33308
SC Clinical Research
Garden Grove, California, 92844
Clinical Research Advantage
Glendale, Arizona, 85306
Advances in Health
Houston, Texas, 77030
East Coast Institute for Clinical Research
Jacksonville, Florida, 32204
East Coast Institute for Research
Jacksonville, Florida, 32204
East Coast Institute for Research
Jacksonville, Florida, 32258
South Orange County Endocrinology
Laguna Hills, California, 92653
Premier Urology Associates
Lawrenceville, New Jersey, 08648
Baptist Health Center for Clinical Research
Little Rock, Arkansas, 72205
Anthony Mills, MD
Los Angeles, California, 90069
Well Pharma Medical Research
Miami, Florida, 33143
Cetero Research
Miami Gardens, Florida, 33169
Clinical Research Advantage
Phoenix, Arizona, 85020
DMI Research
Pinellas Park, Florida, 33782
Ebon Bourne, MD
Plantation, Florida, 33324
Granger Medical Clin ic
Riverton, Utah, 84065
SD Uro-Research
San Diego, California, 92103
San Diego Sexual Medicine
San Diego, California, 92120
SC Clinical Research
Santa Ana, California, 92703
Meridien Research
St. Petersburg, Florida, 33709
Breco Research
Sugar Land, Texas, 77479
West Coast Clinical Research
Tarzana, California, 91356
IRC Clinics
Towson, Maryland, 21204
Center of Reproductive Medicine
Webster, Texas, 77598

Other trials in United States

About this study

Official title: An Open Label, Escalating Dose, 6 Month Phase III Safety Study Of Enclomiphene Citrate in the Treatment of Men With Secondary Hypogonadism

ZA-300 is meant to determine the safety profile of Androxal (enclomiphene citrate) in men with secondary hypogonadism.

Read the detailed description

This study is a phase III, open label safety study with a six month active dosing period. All subjects will be started at 12.5 mg Androxal and titrated to 25 mg if needed. Safety will be assessed by physical and visual acuity exams, slit lamp 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
Androxal, oral, 12.5 mg capsule, taken once daily. Dose may be increased from 12.5 mg to 25 mg if indicated

Study groups in NCT01534208
Study group	Role	What they receive
Androxal 12.5 mg	Experimental	Androxal 12.5 mg daily Receives: Drug: Androxal
Androxal 25 mg	Experimental	Androxal 25 mg daily Receives: Drug: Androxal

What is being measured

The primary outcome is the main question the study is designed to answer.

Change From Baseline in Total Morning Testosterone at 26 Weeks
Changes in values from baseline of total morning testosterone levels at Week 26
Measured: 6 months
Change From Baseline in LH
Mean change from baseline in LH at end of treatment (26 weeks)
Measured: 6 months
Absolute Values of Morning Testosterone
Absolute values of morning testosterone at end of treatment (26 weeks)
Measured: 6 months
Mean Change From Baseline FPG
Mean changes in Fasting Plasma Glucose from baseline to end of treatment (26 weeks)
Measured: 6 months
Change From Baseline in BMI
Mean change from baseline in BMI at end of treatment (26 weeks)
Measured: 6 months
Change From Baseline in FSH
Change from baseline in FSH at end of treatment (26 weeks)
Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2012Oct 2013

First posted16 Feb 2012 (estimated)
Study startMay 2012
Primary completionOct 2013
Study completionOct 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
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: Parallel groups
Masking: None (open label)
Enrolment: 499 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01534208
Sponsor's protocol ID: ZA-300
Status last verified: Jun 2014
First submitted: 9 Feb 2012
Last updated: 24 Jul 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 24 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open Label, Escalating Dose, 6 Month Phase III Safety Study Of Enclomiphene Citrate in the Treatment of Men With Secondary Hypogonadism
ClinicalTrials.gov ID: NCT01534208
Acronym / sponsor ID: ZA-300
Conditions: Secondary Hypogonadism
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 499 participants (actual)
Lead sponsor: Repros Therapeutics Inc.Industry (pharma, biotech, devices)
Study start: May 2012
Primary completion: Oct 2013 (actual)
Study completion: Oct 2013 (actual)
First posted: 16 Feb 2012 (estimated)
Results: Posted 24 Jul 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

ZA-300 is meant to determine the safety profile of Androxal (enclomiphene citrate) in men with secondary hypogonadism.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Androxal 12.5 mg	Experimental	Drug: AndroxalAndroxal 12.5 mg daily
Androxal 25 mg	Experimental	Drug: AndroxalAndroxal 25 mg daily

Who may qualify

Ages: 18 to 65 years
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Secondary hypogonadal males between the ages of 18 and 65
Men currently using topical testosterone products should wash-out for at least 7 days before Visit 1.
All clinical laboratory tests within normal ranges (any clinically significant deviation of laboratory results will require approval of sponsor)
Previously or concurrently diagnosed as having secondary hypogonadism and confirmed with morning testosterone level < 350 ng/dL for men age < 55 and < 300ng/dl for men age 55-65
LH < 15mIU/mL (at Visit 1 only)

Key exclusion criteria (20 listed)

Use of an injectable pelleted testosterone within 6 months prior to study (men currently on topical testosterone products may be enrolled in the study after a 7-day washout period).
Use testosterone injection, 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
Uncontrolled hypertension based on the Investigator's assessment at baseline. Subjects treated for Type II diabetes will be allowed into the study.
A hematocrit ≥ 51% or a hemoglobin ≥ 17 g/dL

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 citrateAndroxal, oral, 12.5 mg capsule, taken once daily. Dose may be increased from 12.5 mg to 25 mg if indicated	Drug	Androxal 12.5 mg, Androxal 25 mg

Primary outcome

Change From Baseline in Total Morning Testosterone at 26 Weeks
Time frame: 6 months
Changes in values from baseline of total morning testosterone levels at Week 26
Change From Baseline in LH
Time frame: 6 months
Mean change from baseline in LH at end of treatment (26 weeks)
Absolute Values of Morning Testosterone
Time frame: 6 months
Absolute values of morning testosterone at end of treatment (26 weeks)
Mean Change From Baseline FPG
Time frame: 6 months
Mean changes in Fasting Plasma Glucose from baseline to end of treatment (26 weeks)
Change From Baseline in BMI
Time frame: 6 months
Mean change from baseline in BMI at end of treatment (26 weeks)
Change From Baseline in FSH
Time frame: 6 months
Change from baseline in FSH at end of treatment (26 weeks)

Results and safety

Results posted to the registry on 24 Jul 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Androxal 12.5 mg	216	159
Androxal 25 mg	283	234

Primary outcome: Change From Baseline in Total Morning Testosterone at 26 Weeks

Time frame: 6 months. Mean (Standard Deviation). Unit: ng/dL

Measure	Androxal 12.5 mg n = 168	Androxal 25 mg n = 242
Value	280.9 (141.4)	214.7 (154.7)

Population analysed: Intent to Treat population

Primary outcome: Change From Baseline in LH

Time frame: 6 months. Mean (Standard Deviation). Unit: mIu/mL

Measure	Androxal 12.5 mg n = 168	Androxal 25 mg n = 242
Value	4.81 (5.69)	4.27 (4.29)

Population analysed: ITT

Primary outcome: Absolute Values of Morning Testosterone

Time frame: 6 months. Mean (Standard Deviation). Unit: ng/dL

Measure	Androxal 12.5 mg n = 216	Androxal 25 mg n = 283
Value	511.6 (140.8)	416.7 (154.7)

Population analysed: ITT

Primary outcome: Mean Change From Baseline FPG

Time frame: 6 months. Mean (Standard Deviation). Unit: mg/dL

Measure	Androxal 12.5 mg n = 168	Androxal 25 mg n = 242
Value	-5.4 (30.8)	-5.0 (29.3)

Adverse events

Time frame: From first administration of study drug until 8 weeks after end of treatment (8 months total). Other adverse events reported at 3% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Androxal 12.5 mg	6 of 207 (2.9%)	66 of 207 (31.9%)	Not reported
Androxal 25 mg	9 of 283 (3.2%)	92 of 283 (32.5%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Sponsor home 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.

Joseph S Podolski study chair

Repros Therapeutics Inc.

31 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 in people with Secondary Hypogonadism, run by Repros Therapeutics Inc. at 31 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 20 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 24 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 31 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 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?

Yes. Results are posted in the registry (first posted 24 Jul 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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 From Baseline in Total Morning Testosterone at 26 Weeks (time frame: 6 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01534208.

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 24 Jul 2014.