Secondary HypogonadismPhase 2NCT01386606

The Effect on Androxal Versus Androgel on Morning Testosterone in Men With Secondary Hypogonadism (Low Testosterone)

A Phase 2 study testing Androxal (enclomiphene citrate) and Testosterone in people with Secondary Hypogonadism, run by Repros Therapeutics Inc. at 2 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

The study will determine the effects of three doses of Androxal(enclomiphene citrate)on morning testosterone versus AndroGel(approved topical treatment)in men with low testosterone (<350 ng/dL)after 6 weeks of continuous dosing. 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 (enclomiphene citrate) and Testosterone
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 60 participants
Where: 2 sitesUnited States
Study dates: Jun 2011to Oct 2011
Phase: Phase 2
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

Healthy males between the ages of 18 and 65 years of age exhibiting morning testosterone ≤350 ng/dL.
All clinical laboratory tests within normal ranges (any clinically significant deviation of laboratory results will require approval of sponsor)
Ability to complete the study in compliance with the protocol
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 a semen sample in the clinic

Who cannot join

Use of an injectable, oral, topical, or subcutaneous pelleted testosterone within 3 months prior to study
Use of spironolactone, cimetidine, 5α-reductase inhibitors, hCG, androgen, estrogen, anabolic steroid, DHEA, or herbal hormone products during the study
Use of Clomid in the past year or during the study
Uncontrolled hypertension or diabetes mellitus based on the Investigator's assessment at baseline. Subjects treated for Type II diabetes but exhibiting glycemic control will be allowed into the study. Newly diagnosed diabetics need to be treated for at least 48 hours before being enrolled in the study.
A hematocrit ≥51 % or a hemoglobin ≥17 g/dL
Clinically significant abnormal findings on screening examination

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
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, vasectomy, or tumors of the pituitary)
History of breast cancer
History of prostate cancer or a suspicion of prostate disease unless ruled out by prostate biopsy, or a PSA >3.6
History of known hyperprolactinemia with or without a tumor
Chronic use of medications use such as glucocorticoids
Chronic use of narcotics
Subjects known to be positive for HIV
Subjects with end stage renal disease
Subjects with cystic fibrosis (mutation of the CFTR gene)
Subjects unable to provide a semen sample in the clinic
Subject has a BMI >42 kg/m2

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Centex Research
Houston, Texas, 77062
Cetero Research
San Antonio, Texas, 78229

Other trials in United States

About this study

Official title: A Randomized, Single Blind, Multi-Center Phase II Study to Evaluate the Effect of Three Different Doses of Androxal and AndroGel on 24-Hour Luteinizing Hormone and Testosterone in Normal Healthy Men

Read the detailed description

Study will require 7 visits, which includes 2 overnight stays in a clinic. One visit is an eye exam. Blood samples are required at all visits including sampling every hour for a 24 hour time period during the 2 overnight stays. A six month extension study will be available for all subjects completing the 6-week study.

Conditions: Secondary Hypogonadism
Being tested: Androxal (enclomiphene citrate), 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 (enclomiphene citrate)Drug
Also called Androxal, low testosterone therapy
capsule oral
1X a day 6 weeks
TestosteroneDrug
Also called topical testosterone, testosterone gel, exogenous testosterone
topical gel
1X a day 6 weeks

Study groups in NCT01386606
Study group	Role	What they receive
Androxal 6.25 mg	Experimental	Androxal 6.25 mg/day Receives: Drug: Androxal (enclomiphene citrate)
Androxal 12.5 mg	Experimental	Androxal 12.5 mg/day Receives: Drug: Androxal (enclomiphene citrate)
Androxal 25 mg	Experimental	Androxal 25 mg/day Receives: Drug: Androxal (enclomiphene citrate)
AndroGel	Active comparator	AndroGel 5G topical testosterone Receives: Drug: Testosterone

What is being measured

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

24 Hour Average and Maximum Testosterone Concentration
The primary efficacy endpoint will be 24-hour average (TTavg) and maximum (TTmax) testosterone concentration compared to baseline after 6 weeks of treatment.
Time points (in hours after dosing) at which testosterone concentration was measured are: 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24.
Measured: Baseline and Week 6

Secondary outcomes (2)

Change in Leuteinizing Hormone (LH)
Changes in morning LH after continuous dosing
Measured: Baseline, Week 2, Week 4, Week 6
Change in Follicle Stimulating Hormone (FSH)
Changes in morning FSH after continuous dosing
Measured: Baseline, Week 2, Week 4, Week 6

Timeline

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

Jun 2011Oct 2011

First posted1 Jul 2011 (estimated)
Study startJun 2011
Primary completionOct 2011
Study completionOct 2011

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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01386606
Sponsor's protocol ID: ZA-204
Status last verified: Aug 2015
First submitted: 29 Jun 2011
Last updated: 23 Sep 2015
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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All Secondary Hypogonadism trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Single Blind, Multi-Center Phase II Study to Evaluate the Effect of Three Different Doses of Androxal and AndroGel on 24-Hour Luteinizing Hormone and Testosterone in Normal Healthy Men
ClinicalTrials.gov ID: NCT01386606
Acronym / sponsor ID: ZA-204
Conditions: Secondary Hypogonadism
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 60 participants (actual)
Lead sponsor: Repros Therapeutics Inc.Industry (pharma, biotech, devices)
Study start: Jun 2011
Primary completion: Oct 2011 (actual)
Study completion: Oct 2011 (actual)
First posted: 1 Jul 2011 (estimated)
Results: Posted 23 Sep 2015

Clinical summary

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

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 4

Arm	Type	Receives
Androxal 6.25 mg	Experimental	Drug: Androxal (enclomiphene citrate)Androxal 6.25 mg/day
Androxal 12.5 mg	Experimental	Drug: Androxal (enclomiphene citrate)Androxal 12.5 mg/day
Androxal 25 mg	Experimental	Drug: Androxal (enclomiphene citrate)Androxal 25 mg/day
AndroGel	Active comparator	Drug: TestosteroneAndroGel 5G topical testosterone

Who may qualify

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

Key inclusion criteria (6 listed)

Healthy males between the ages of 18 and 65 years of age exhibiting morning testosterone ≤350 ng/dL.
All clinical laboratory tests within normal ranges (any clinically significant deviation of laboratory results will require approval of sponsor)
Ability to complete the study in compliance with the protocol
Ability to understand and provide written informed consent
Agreement to use a condom, and with a fertile female partner, another form of contraception.

Key exclusion criteria (20 listed)

Use of an injectable, oral, topical, or subcutaneous pelleted testosterone within 3 months prior to study
Use of spironolactone, cimetidine, 5α-reductase inhibitors, hCG, androgen, estrogen, anabolic steroid, DHEA, or herbal hormone products during the study
Use of Clomid in the past year or during the study
Uncontrolled hypertension or diabetes mellitus based on the Investigator's assessment at baseline. Subjects treated for Type II diabetes but exhibiting glycemic control will be allowed into the study. Newly diagnosed diabetics need to be treated for at least 48 hours before being enrolled in 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
Androxal (enclomiphene citrate)Also: Androxal, low testosterone therapycapsule oral 1X a day 6 weeks	Drug	Androxal 12.5 mg, Androxal 25 mg, Androxal 6.25 mg
TestosteroneAlso: topical testosterone, testosterone gel, exogenous testosteronetopical gel 1X a day 6 weeks	Drug	AndroGel

Primary outcome

24 Hour Average and Maximum Testosterone Concentration
Time frame: Baseline and Week 6
The primary efficacy endpoint will be 24-hour average (TTavg) and maximum (TTmax) testosterone concentration compared to baseline after 6 weeks of treatment. Time points (in hours after dosing) at which testosterone concentration was measured are: 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24.

2 secondary outcomes

Change in Leuteinizing Hormone (LH)
Time frame: Baseline, Week 2, Week 4, Week 6
Change in Follicle Stimulating Hormone (FSH)
Time frame: Baseline, Week 2, Week 4, Week 6

Results and safety

Results posted to the registry on 23 Sep 2015, 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 6.25 mg	16	12
Androxal 12.5 mg	14	10
Androxal 25 mg	16	13
AndroGel	14	13

Primary outcome: 24 Hour Average and Maximum Testosterone Concentration

Time frame: Baseline and Week 6. Mean (Standard Deviation). Unit: ng/dL

Measure	Androxal 6.25 mg n = 12	Androxal 12.5 mg n = 10	Androxal 25 mg n = 13	AndroGel n = 13
TTavg at Baseline	262.3 (80.3)	373.6 (172.1)	298.3 (100.5)	322.4 (102.9)
TTavg at Week 6	392.4 (152.6)	460.8 (129.1)	586.7 (142.4)	543.9 (229.8)
TTmax at Baseline	358.5 (120.5)	513.7 (222.2)	425.9 (114.3)	562.3 (488.5)
TTmax at Week 6	524.5 (178.7)	607.5 (167.7)	764.3 (158.7)	930.1 (550.4)

Androxal 6.25 mg vs Androxal 12.5 mg vs Androxal 25 mg vs AndroGel: p = 0.056, Regression, Linear
Androxal 6.25 mg vs Androxal 12.5 mg vs Androxal 25 mg vs AndroGel: Regression Coefficient: -45.77 (95% CI -143.5 to 51.98), p = 0.436, Regression, Linear
Androxal 6.25 mg vs Androxal 12.5 mg vs Androxal 25 mg vs AndroGel: Regression Coefficient: -110.9 (95% CI -210.6 to -11.23), p = 0.068, Regression, Linear

Population analysed: ITT, subjects who received at least one dose of study drug and had at least one post-dose efficacy measure.

2 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Androxal 6.25 mg	0 of 16 (0%)	2 of 16 (12.5%)	Not reported
Androxal 12.5 mg	0 of 14 (0%)	1 of 14 (7.1%)	Not reported
Androxal 25 mg	0 of 16 (0%)	1 of 16 (6.3%)	Not reported
AndroGel	0 of 14 (0%)	4 of 14 (28.6%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Sponsor websiteLink provided by the sponsor.
Related InfoLink 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.

Jolene Berg, MD principal investigator

Cetero Research, San Antonio

2 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 Testosterone 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 6 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 23 Sep 2015. 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 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?

Yes. Results are posted in the registry (first posted 23 Sep 2015). 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?

24 Hour Average and Maximum Testosterone Concentration (time frame: Baseline and Week 6). 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 NCT01386606.

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 23 Sep 2015.