Secondary HypogonadismPhase 2NCT01270841
Normalization of Morning Testosterone Levels in Men With Secondary Hypogonadism
A Phase 2 study testing topical testosterone and Androxal in people with Secondary Hypogonadism, run by Repros Therapeutics Inc. at 18 sites in United States.
Trial summary
The Purpose of the study is to determine the effects of Androxal on morning testosterone and reproductive status in men with secondary hypogonadism(confirmed morning Testosterone less than 250 ng/dL), compared to changes with placebo, or Testim (topical testosterone). Read more about this study
- Who is it for?
- Ages 21 to 65 years, men only
- Conditions the study is for
- Secondary Hypogonadism
- What is being tested?
- topical testosterone and Androxal
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 83 participants
- Where
- 18 sitesUnited States
- Study dates
- Jan 2011to Dec 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 21 to 65 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Healthy males between the ages of 21 and 65 years of age
- 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 morning testosterone <250ng/dL (two assessments at least 10 days apart)
- Ability to complete the study in compliance with the protocol
- Ability to understand and provide written informed consent
- Agreement to use double barrier contraception if with a fertile female partner
- Agreement to provide a semen sample in the clinic
Who cannot join
- Use of an injectable, oral, topical, or subcutaneous pelleted testosterone within 6 months prior to study
- Use of 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 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
- A hematocrit >50% or a hemoglobin >17 g/dL
- Clinically significant abnormal findings on screening examination
Show all 18Show 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, vasectomy, 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 hyperprolactinemia with or without a tumor
- Chronic use of medications use such as glucocorticoids
- Subjects with cystic fibrosis (mutation of the CFTR gene)
- Subjects unable to provide a semen sample in the clinic
- Subject has a BMI >36 kg/m2
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
United States18 sites
Discovery Clinical Trials
Austin, Texas, 78758
Research Across America
Carrollton, Texas, 75010
Paradigm Clinical Inc.
Garden Grove, California, 92844
Weill Cornell Medical College and Smith Institute
Great Neck, New York, 11021
Texas Urology Specialist
Houston, Texas, 77024
Centex Research
Houston, Texas, 77062
Endocrine and Psychiatry Center
Houston, Texas, 77095
Protenium Clinical Research
Hurst, Texas, 76054
R/D Clinical Research
Lake Jackson, Texas, 77566
Affiliated Clinical Research
Las Vegas, Nevada, 89109
Affiliated Clinical Research Inc.
Las Vegas, Nevada, 89144
Jed Kaminetsky
New York, New York, 10016
Natan Bar-Chama
New York, New York, 10022
Michael A Werner
Purchase, New York, 10577
Northern California Research Corp
Sacramento, California, 95831
Cetero Research
San Antonio, Texas, 78229
Medical Center for Clinical Research
San Diego, California, 92108
Los Angeles Biomedical Research Institute
Torrance, California, 90502
About this study
Official title: A Randomized, Double Blind, Placebo and Active Controlled, Parallel, Multi-Center Phase IIb Study to Evaluate Normalization of Morning Testosterone Levels in Men With Secondary Hypogonadism
The Purpose of the study is to determine the effects of Androxal on morning testosterone and reproductive status in men with secondary hypogonadism(confirmed morning Testosterone less than 250 ng/dL), compared to changes with placebo, or Testim (topical testosterone). The effects of Testim versus placebo on reproductive status will also be examined. Study subjects must not be currently using a topical testosterone.
Read the detailed description
This study is a phase IIb, 4 arm study with three month active dosing period. Three of the four treatment groups will be randomized to either Androxal or placebo in a double-blind fashion, and the fourth treatment group will receive open-label Testim. The doses of Androxal in the blinded portion of the study will be 12.5 mg and 25 mg, in capsule form.
- Conditions
- Secondary Hypogonadism
- Being tested
- Placebo, topical testosterone, Androxal
- Medical subject headings
- Hypogonadism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Placebo capsule 1x daily for 3 months
topical testosteroneDrug
Also called Testim, AndroGel
testosterone gel applied 1x daily for 3 months
AndroxalDrug
Also called Enclomiphene citrate
Capsule of either 12.5 mg or 25 mg Androxal, 1x daily for 3 months
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo Receives: Drug: Placebo |
| Testim (topical testosterone) | Active comparator | Testim (topical testosterone) Receives: Drug: topical testosterone |
| Androxal 12.5 mg | Experimental | Androxal 12.5 mg/day Receives: Drug: Androxal |
| Androxal 25 mg | Experimental | Androxal 25 mg/day Receives: Drug: Androxal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Total Morning Testosterone
Changes in values from baseline in total morning testosterone levels at month 3 comparing Androxal 12.5 and 25 mg to placebo and Testim
Measured: 3 months
Secondary outcomes (3)
Change in Luteinizing Hormone Levels
Changes in values from baseline in LH at month 3
Measured: 3 months
Change in FSH After 3 Months of Treatment
Measured: 3 months
Reproductive Safety
Change from baseline in sperm concentration
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2011 (estimated)
- Study startJan 2011
- Primary completionDec 2011
- Study completionDec 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.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- Repros Therapeutics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Larry Lipshultz, MD, Principal investigator, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01270841
- Sponsor's protocol ID
- ZA-203
- Status last verified
- Jun 2014
- First submitted
- 4 Jan 2011
- Last updated
- 28 Jul 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Wiehle RD, Fontenot GK, Wike J, Hsu K, Nydell J, Lipshultz L; ZA-203 Clinical Study Group. Enclomiphene citrate stimulates testosterone production while preventing oligospermia: a randomized phase II clinical trial comparing topical testosterone. Fertil Steril. 2014 Sep;102(3):720-7. doi: 10.1016/j.fertnstert.2014.06.004. Epub 2014 Jul 17.
PubMed 25044085
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double Blind, Placebo and Active Controlled, Parallel, Multi-Center Phase IIb Study to Evaluate Normalization of Morning Testosterone Levels in Men With Secondary Hypogonadism
- ClinicalTrials.gov ID
- NCT01270841
- Acronym / sponsor ID
- ZA-203
- Conditions
- Secondary Hypogonadism
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- Repros Therapeutics Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2011
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 5 Jan 2011 (estimated)
- Results
- Posted 28 Jul 2014
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 the study is to determine the effects of Androxal on morning testosterone and reproductive status in men with secondary hypogonadism(confirmed morning Testosterone less than 250 ng/dL), compared to changes with placebo, or Testim (topical testosterone). The effects of Testim versus placebo on reproductive status will also be examined. Study subjects must not be currently using a topical testosterone.
Detailed description
This study is a phase IIb, 4 arm study with three month active dosing period. Three of the four treatment groups will be randomized to either Androxal or placebo in a double-blind fashion, and the fourth treatment group will receive open-label Testim. The doses of Androxal in the blinded portion of the study will be 12.5 mg and 25 mg, in capsule form.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboPlacebo |
| Testim (topical testosterone) | Active comparator | Drug: topical testosteroneTestim (topical testosterone) |
| Androxal 12.5 mg | Experimental | Drug: AndroxalAndroxal 12.5 mg/day |
| Androxal 25 mg | Experimental | Drug: AndroxalAndroxal 25 mg/day |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Healthy males between the ages of 21 and 65 years of age
- 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 morning testosterone <250ng/dL (two assessments at least 10 days apart)
- Ability to complete the study in compliance with the protocol
- Ability to understand and provide written informed consent
Key exclusion criteria (18 listed)
- Use of an injectable, oral, topical, or subcutaneous pelleted testosterone within 6 months prior to study
- Use of 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 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
- A hematocrit >50% 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 |
|---|---|---|
| PlaceboPlacebo capsule 1x daily for 3 months | Drug | Placebo |
| topical testosteroneAlso: Testim, AndroGeltestosterone gel applied 1x daily for 3 months | Drug | Testim (topical testosterone) |
| AndroxalAlso: Enclomiphene citrateCapsule of either 12.5 mg or 25 mg Androxal, 1x daily for 3 months | Drug | Androxal 12.5 mg, Androxal 25 mg |
Primary outcome
Change in Total Morning Testosterone
Time frame: 3 months
Changes in values from baseline in total morning testosterone levels at month 3 comparing Androxal 12.5 and 25 mg to placebo and Testim
3 secondary outcomes
Change in Luteinizing Hormone Levels
Time frame: 3 months
Change in FSH After 3 Months of Treatment
Time frame: 3 months
Reproductive Safety
Time frame: 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 25044085Wiehle RD, Fontenot GK, Wike J, Hsu K, Nydell J, Lipshultz L; ZA-203 Clinical Study Group. Enclomiphene citrate stimulates testosterone production while preventing oligospermia: a randomized phase II clinical trial comparing topical testosterone. Fertil Steril. 2014 Sep;102(3):720-7. doi: 10.1016/j.fertnstert.2014.06.004. Epub 2014 Jul 17.
- Sponsor websiteLink provided by the sponsor.
- WebsiteLink 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.
Larry Lipshultz, MD principal investigator
Baylor College of Medicine
18 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 topical testosterone and Androxal in people with Secondary Hypogonadism, run by Repros Therapeutics Inc. at 18 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 18 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 28 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 18 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. Some participants in this study may receive a placebo. 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 28 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 in Total Morning Testosterone (time frame: 3 months). 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 NCT01270841, which also lists 1 linked publication.
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 28 Jul 2014.