Secondary HypogonadismPhase 2NCT00706719

To Evaluate Sperm Parameters in Men With Secondary Hypogonadism Previously Treated With Topical Testosterone

A Phase 2 study testing 25 mg Androxal and Testim 1% 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

Who is it for?: Ages 21 to 60 years, men only
Conditions the study is for: Secondary Hypogonadism
What is being tested?: 25 mg Androxal and Testim 1%
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 17 participants
Where: 2 sitesUnited States
Study dates: Jun 2008to Aug 2009
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 21 to 60 years
Men only
No healthy volunteers
Adult

Who may be able to join

Healthy adult males between 21 and 60 years of age who have been diagnosed with AIHH.
Subjects must have been treated with a topical testosterone replacement therapy (typically AndroGel® or Testim®) for at least 6 months at enrollment and for not more than 2 years.

Who cannot join

A history of idiopathic infertility due to primary hypogonadism, testicular failure, Kallmann's syndrome or any other infertility condition.
Subjects demonstrating any clinically significant medical condition rendering the subjects infertile or marginally fertile other than AIHH.
Men with a history of, known, or suspected prostate disease not ruled out by a prostate biopsy, or a prostate specific antigen (PSA)>3.6 or clinical suspicion of current prostate disease.
Men with a hematocrit in excess of 50 % or hemoglobin >17 g/dl

Trial locations and contacts

2 sites in 1 country.

United States2 sites

University Urology Associates
New York, New York, 10016
MAZE Labs
Purchase, New York, 10577

Other trials in United States

About this study

Official title: A Randomized, Open-Label, Fixed Dose, Active-Control, Multi-Center Phase IIB Study to Evaluate Fertility in Men With Secondary Hypogonadism, Comparing Androxal® to a Topical Testosterone in Men Previously Treated With Topical Testosterone.

Read the detailed description

The study was designed to determine if Androxal® would affect sperm parameters (count, concentration, volume) in men with secondary hypogonadism who have been previously treated with topical testosterone. A maximum of twelve subjects per group were randomized to daily treatments of Androxal® or topical testosterone (Testim®) for six months. The protocol was later amended to include a treatment group who received Androxal after a 3 month wash out period.

Conditions: Secondary Hypogonadism
Being tested: 25 mg Androxal, Testim 1%
Keywords: Adult Onset Idiopathic Hypothalamic Hypogonadism (AIHH), Secondary hypogonadism, Semen volume, Sperm count, Sperm motility
Medical subject headings: Hypogonadism

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

25 mg AndroxalDrug
Also called Enclomiphene citrate
25 mg Androxal capsules, 1 capsule daily for 6 months
Testim 1%Drug
Also called Topical testosterone
Testim 1% gel, dosage to be titrated according to manufacturer's instructions, once daily for 6 months

Study groups in NCT00706719
Study group	Role	What they receive
25 mg Androxal no wash out	Experimental	1 capsule daily for 6 months of 25 mg of Androxal in men without a 3 month wash out period Receives: Drug: 25 mg Androxal
Testim 1% (topical testosterone)	Active comparator	Testim 1% Gel applied topically for 6 months Receives: Drug: Testim 1%
25 mg Androxal wash out	Experimental	1 x 25 mg Androxal capsule daily for 6 months in men with a previous 3 month washout period of topical testosterone Receives: Drug: 25 mg Androxal

What is being measured

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

Sperm Concentration
Total sperm concentration was measured.
Measured: Baseline, Month 3, Month 6, Follow-Up (Month 7)
Motile Total Sperm Count
Motile total sperm count was measured.
Measured: Baseline, Month 3, Month 6, Follow-Up (Month 7)
Semen Volume
Semen volume was measured.
Measured: Baseline, Month 3, Month 6, Follow-Up (Month 7)

Secondary outcomes (2)

Luteinizing Hormone (LH) Levels
LH levels were measured.
Measured: Baseline, Month 3, Month 6, Follow-Up (Month 7)
Follicle Stimulating Hormone (FSH) Levels
FSH levels were measured.
Measured: Baseline, Month 3, Month 6, Follow-Up (Month 7)

Timeline

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

Jun 2008Aug 2009

First posted27 Jun 2008 (estimated)
Study startJun 2008
Primary completionJul 2009
Study completionAug 2009

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: None (open label)
Enrolment: 17 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00706719
Sponsor's protocol ID: ZA-201
Status last verified: Jul 2015
First submitted: 25 Jun 2008
Last updated: 19 Aug 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 19 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Open-Label, Fixed Dose, Active-Control, Multi-Center Phase IIB Study to Evaluate Fertility in Men With Secondary Hypogonadism, Comparing Androxal® to a Topical Testosterone in Men Previously Treated With Topical Testosterone.
ClinicalTrials.gov ID: NCT00706719
Acronym / sponsor ID: ZA-201
Conditions: Secondary Hypogonadism
Keywords: Adult Onset Idiopathic Hypothalamic Hypogonadism (AIHH), Secondary hypogonadism, Semen volume, Sperm count, Sperm motility
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 17 participants (actual)
Lead sponsor: Repros Therapeutics Inc.Industry (pharma, biotech, devices)
Study start: Jun 2008
Primary completion: Jul 2009 (actual)
Study completion: Aug 2009 (actual)
First posted: 27 Jun 2008 (estimated)
Results: Posted 8 Oct 2010

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: None (open label)
Number of arms: 3

Arm	Type	Receives
25 mg Androxal no wash out	Experimental	Drug: 25 mg Androxal1 capsule daily for 6 months of 25 mg of Androxal in men without a 3 month wash out period
Testim 1% (topical testosterone)	Active comparator	Drug: Testim 1%Testim 1% Gel applied topically for 6 months
25 mg Androxal wash out	Experimental	Drug: 25 mg Androxal1 x 25 mg Androxal capsule daily for 6 months in men with a previous 3 month washout period of topical testosterone

Who may qualify

Ages: 21 to 60 years
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (2 listed)

Healthy adult males between 21 and 60 years of age who have been diagnosed with AIHH.
Subjects must have been treated with a topical testosterone replacement therapy (typically AndroGel® or Testim®) for at least 6 months at enrollment and for not more than 2 years.

Key exclusion criteria (4 listed)

A history of idiopathic infertility due to primary hypogonadism, testicular failure, Kallmann's syndrome or any other infertility condition.
Subjects demonstrating any clinically significant medical condition rendering the subjects infertile or marginally fertile other than AIHH.
Men with a history of, known, or suspected prostate disease not ruled out by a prostate biopsy, or a prostate specific antigen (PSA)>3.6 or clinical suspicion of current prostate disease.
Men with a hematocrit in excess of 50 % or 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
25 mg AndroxalAlso: Enclomiphene citrate25 mg Androxal capsules, 1 capsule daily for 6 months	Drug	25 mg Androxal no wash out, 25 mg Androxal wash out
Testim 1%Also: Topical testosteroneTestim 1% gel, dosage to be titrated according to manufacturer's instructions, once daily for 6 months	Drug	Testim 1% (topical testosterone)

Primary outcome

Sperm Concentration
Time frame: Baseline, Month 3, Month 6, Follow-Up (Month 7)
Total sperm concentration was measured.
Motile Total Sperm Count
Time frame: Baseline, Month 3, Month 6, Follow-Up (Month 7)
Motile total sperm count was measured.
Semen Volume
Time frame: Baseline, Month 3, Month 6, Follow-Up (Month 7)
Semen volume was measured.

2 secondary outcomes

Luteinizing Hormone (LH) Levels
Time frame: Baseline, Month 3, Month 6, Follow-Up (Month 7)
Follicle Stimulating Hormone (FSH) Levels
Time frame: Baseline, Month 3, Month 6, Follow-Up (Month 7)

Results and safety

Results posted to the registry on 8 Oct 2010, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Group A Testim (Topical Testosterone)	5	5
Group B Androxal no Washout	7	6
Group C Androxal With Wash Out	5	1

Primary outcome: Sperm Concentration

Time frame: Baseline, Month 3, Month 6, Follow-Up (Month 7). Mean (Standard Deviation). Unit: millions sperm/mL

Measure	Group A Testim n = 5	Group B Androxal no Wash Out n = 6
Baseline	0.54 (0.74)	72.8 (92.7)
Month 3	3.00 (5.20)	182.6 (115.5)
Month 6	23.14 (30.67)	168.5 (92.9)
Follow-Up (Month 7)	21.03 (28.90)	164.0 (71.2)

Group A Testim vs Group B Androxal no Wash Out: p = 0.118, t-test, 2 sided
Group A Testim vs Group B Androxal no Wash Out: p = 0.006, t-test, 2 sided
Group A Testim vs Group B Androxal no Wash Out: p = 0.009, t-test, 2 sided

Population analysed: Subjects in Group A and B who completed the study. No analysis was performed for subjects in Group C because only 1 subject completed the study.

Primary outcome: Motile Total Sperm Count

Time frame: Baseline, Month 3, Month 6, Follow-Up (Month 7). Mean (Standard Deviation). Unit: millions sperm

Measure	Group A Testim n = 5	Group B Androxal no Wash Out n = 6
Baseline	0.3 (0.48)	99.0 (159.6)
Month 3	2.42 (5.41)	214.7 (166.0)
Month 6	40.4 (55.3)	146.9 (120.0)
Follow-Up (Month 7)	38 (52.5)	100.3 (103.8)

Group A Testim vs Group B Androxal no Wash Out: p = 0.15, Wilcoxon (Mann-Whitney)
Group A Testim vs Group B Androxal no Wash Out: p = 0.0067, Wilcoxon (Mann-Whitney)
Group A Testim vs Group B Androxal no Wash Out: p = 0.10, Wilcoxon (Mann-Whitney)

Population analysed: Subjects in Group A and B who completed the study. No analysis was performed for subjects in Group C because only 1 subject completed the study.

Primary outcome: Semen Volume

Time frame: Baseline, Month 3, Month 6, Follow-Up (Month 7). Mean (Standard Deviation). Unit: mL

Measure	Group A Testim n = 5	Group B Androxal no Wash Out n = 6
Baseline	2.34 (1.43)	2.23 (0.81)
Month 3	2.88 (1.40)	2.45 (1.31)
Month 6	1.90 (1.03)	2.48 (1.53)
Follow-Up (Month 7)	3.34 (0.83)	2.40 (0.58)

Group A Testim vs Group B Androxal no Wash Out: p = 0.880, t-test, 2 sided
Group A Testim vs Group B Androxal no Wash Out: p = 0.612, t-test, 2 sided
Group A Testim vs Group B Androxal no Wash Out: p = 0.488, t-test, 2 sided

Population analysed: Subjects in Group A and B who completed the study. No analysis was performed for subjects in Group C because only 1 subject completed the study.

2 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Group A Testim	0 of 5 (0%)	0 of 5 (0%)	Not reported
Group B Androxal no Wash Out	0 of 7 (0%)	2 of 7 (28.6%)	Not reported
Androxal Wash Out	0 of 5 (0%)	4 of 5 (80%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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.

Ronald Wiehle, PhD study director

Repros Therapeutics Inc.

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 25 mg Androxal and Testim 1% 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 2 inclusion and 4 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 19 Aug 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 8 Oct 2010). 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?

Sperm Concentration (time frame: Baseline, Month 3, Month 6, Follow-Up (Month 7)). The study lists 3 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 NCT00706719.

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 19 Aug 2015.