Secondary HypogonadismPhase 3NCT00962637
Study to Evaluate the Safety and Efficacy of Androxal™ Treatment in Men With Secondary Hypogonadism
A Phase 3 study testing Androxal and AndroGel in people with Secondary Hypogonadism, run by Repros Therapeutics Inc. at 18 sites in United States.
Trial summary
Approximately 4 to 5 million men in the U.S. are testosterone-deficient. Enclomiphene (trans-clomiphene) citrate (Androxal) was evaluated to determine if Androxal increased serum testosterone levels in men with secondary hypogonadism. Subjects were randomly assigned to 1 of 4 treatments groups. Read more about this study
- Who is it for?
- Ages 18 to 68 years, men only
- Conditions the study is for
- Secondary Hypogonadism
- What is being tested?
- Androxal and AndroGel
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 194 participants
- Where
- 18 sitesUnited States
- Study dates
- Mar 2006to May 2007
- Phase
- Phase 3
- 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 18 to 68 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Total serum testosterone concentrations < 300 ng/dL at baseline
Who cannot join
- Presence or history of prostate cancer
- Elevated PSA > 3.5 ng/mL
- Additional inclusion and exclusion criteria may apply.
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
United States18 sites
The Center for Sexual Medicine at Sheppard Pratt
Baltimore, Maryland, 21285
Alabama Clinical Therapeutics, LLC
Birmingham, Alabama, 35235
Northern California Research Corp.
Carmichael, California, 95608
Northeast Indiana Research, LLC
Fort Wayne, Indiana, 46825
Advanced Biomedical Research, Inc.
Hackensack, New Jersey, 07601
Medical Affiliated Research Center, Inc.
Huntsville, Alabama, 35801
Office of Michael Mall, MD
Las Vegas, Nevada, 89109
Office of Stephen Miller, MD
Las Vegas, Nevada, 89144
Office of Gary S. Karlin
Lawrenceville, New Jersey, 08648
Office of Keith Pierce, MD
Livonia, Michigan, 48152
Commonwealth Biomedical Research
Madisonville, Kentucky, 42431
Prime-Care Clinical Research
Mission Viejo, California, 92691
Medial Research Associates of Nashville
Nashville, Tennessee, 37203
Salt Lake Research
Salt Lake City, Utah, 84107
Urology San Antonio Research, PA
San Antonio, Texas, 78229
Southeastern Research Group, Inc.
Tallahassee, Florida, 32308
Harbor-UCLA Medical Center
Torrance, California, 90502
Chase Medical Research, LLC
Waterbury, Connecticut, 06708
About this study
Official title: A Phase III, Randomized, Double-Blind, Placebo-Controlled, Open-Label, Active-Controlled Study to Evaluate the Safety and Efficacy of Androxal™ Treatment in Men With Secondary Hypogonadism
Approximately 4 to 5 million men in the U.S. are testosterone-deficient. Enclomiphene (trans-clomiphene) citrate (Androxal) was evaluated to determine if Androxal increased serum testosterone levels in men with secondary hypogonadism. Subjects were randomly assigned to 1 of 4 treatments groups. Appropriate amounts of medications were dispensed at each visit. Subjects took their medications orally or by rubbing it onto the skin (depending on the treatment assignment) once daily for up to 6 months. Treatment visits occurred at approximately 4-week intervals for Months 1, 2, and 3 and then at 6-week intervals for Months 4, 5, and 6.
- Conditions
- Secondary Hypogonadism
- Being tested
- Androxal, AndroGel, Placebo
- Keywords
- Secondary Hypogonadism
- 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
12.5 mg once daily
AndroxalDrug
Also called Enclomiphene citrate
25 mg once daily
AndroGelDrug
5 g applied topically daily. The subject was to return to the clinic every 2 weeks for the first 2 months to monitor serum testosterone levels. If testosterone concentration remained below the normal level, the dose of AndroGel® could have been increased to 10 g and then to 15 g according to the guidance provided in the product package insert.
PlaceboDrug
1 capsule daily
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Androxal™ 12.5 mg Receives: Drug: Androxal |
| 2 | Experimental | Androxal™ 25 mg Receives: Drug: Androxal |
| 3 | Active comparator | AndroGel® Receives: Drug: AndroGel |
| 4 | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the safety of Androxal™ administered in men with secondary hypogonadism
Measured: Six months
Secondary outcomes (1)
Demonstrate that treatment of men with secondary hypogonadism with Androxal™ was non-inferior to treatment with the active control, AndroGel®
Measured: Six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2009 (estimated)
- Study startMar 2006
- Primary completionMay 2007
- Study completionMay 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 194 participants (actual)
Sponsor and investigators
- Lead sponsor
- Repros Therapeutics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Andre van As, MD, PhD, Study director, Repros Therapeutics Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00962637
- Sponsor's protocol ID
- ZA-003
- Status last verified
- Feb 2010
- First submitted
- 18 Aug 2009
- Last updated
- 11 Feb 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Randomized, Double-Blind, Placebo-Controlled, Open-Label, Active-Controlled Study to Evaluate the Safety and Efficacy of Androxal™ Treatment in Men With Secondary Hypogonadism
- ClinicalTrials.gov ID
- NCT00962637
- Acronym / sponsor ID
- ZA-003
- Conditions
- Secondary Hypogonadism
- Keywords
- Secondary Hypogonadism
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 194 participants (actual)
- Lead sponsor
- Repros Therapeutics Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2006
- Primary completion
- May 2007 (actual)
- Study completion
- May 2007 (actual)
- First posted
- 20 Aug 2009 (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.
Approximately 4 to 5 million men in the U.S. are testosterone-deficient. Enclomiphene (trans-clomiphene) citrate (Androxal) was evaluated to determine if Androxal increased serum testosterone levels in men with secondary hypogonadism. Subjects were randomly assigned to 1 of 4 treatments groups. Appropriate amounts of medications were dispensed at each visit. Subjects took their medications orally or by rubbing it onto the skin (depending on the treatment assignment) once daily for up to 6 months. Treatment visits occurred at approximately 4-week intervals for Months 1, 2, and 3 and then at 6-week intervals for Months 4, 5, and 6.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: AndroxalAndroxal™ 12.5 mg |
| 2 | Experimental | Drug: AndroxalAndroxal™ 25 mg |
| 3 | Active comparator | Drug: AndroGelAndroGel® |
| 4 | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 18 to 68 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Total serum testosterone concentrations < 300 ng/dL at baseline
Key exclusion criteria (3 listed)
- Presence or history of prostate cancer
- Elevated PSA > 3.5 ng/mL
- Additional inclusion and exclusion criteria may apply.
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 citrate12.5 mg once daily | Drug | 1 |
| AndroxalAlso: Enclomiphene citrate25 mg once daily | Drug | 2 |
| AndroGel5 g applied topically daily. The subject was to return to the clinic every 2 weeks for the first 2 months to monitor serum testosterone levels. If testosterone concentration remained below the normal level, the dose of AndroGel® could have been increased to 10 g and then to 15 g according to the guidance provided in the product package insert. | Drug | 3 |
| Placebo1 capsule daily | Drug | 4 |
Primary outcome
Evaluate the safety of Androxal™ administered in men with secondary hypogonadism
Time frame: Six months
1 secondary outcome
Demonstrate that treatment of men with secondary hypogonadism with Androxal™ was non-inferior to treatment with the active control, AndroGel®
Time frame: Six months
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 11 Feb 2010.
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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.
Andre van As, MD, PhD study director
Repros Therapeutics Inc.
18 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 and AndroGel 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 1 inclusion and 3 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 11 Feb 2010. 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 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?
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?
Evaluate the safety of Androxal™ administered in men with secondary hypogonadism (time frame: Six months). 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 11 Feb 2010.