Effect of Treatment on Bone Mineral DensityPhase 3NCT01619683
Assessment of the Effects of Enclomiphene Citrate on Bone Mineral Density in Men With Secondary Hypogonadism
A Phase 3 study testing enclomiphene citrate in people with Effect of Treatment on Bone Mineral Density, run by Repros Therapeutics Inc. at 17 sites in United States.
Trial summary
To determine the effects of 12 months of treatment with Androxal on bone mineral density in men with secondary hypogonadism. Read more about this study
- Who is it for?
- Ages 18 to 60 years, men only
- Conditions the study is for
- Effect of Treatment on Bone Mineral Density
- What is being tested?
- enclomiphene citrate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 17 sitesUnited States
- Study dates
- Sep 2012to Sep 2014
- 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 60 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Overweight (BMI 25 to 42 kg/m2 inclusive, or BMI 23 to 42 inclusive in Asian subjects) males age 18 to 60 inclusive
- 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 <300ng/dL measured twice on separate days. One of the two TT levels must be confirmed at baseline. Subjects who fail this criterion will be enrolled in the placebo group.
- LH <9.4 mIU/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 or pelleted testosterone within 6 months prior to study (men currently on topical products may be enrolled in the study after a 7-day washout period)
- Use of 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 or diabetes mellitus based on the Investigator's assessment at baseline. Subjects treated for Type II diabetes will be allowed into the study. Newly diagnosed diabetics need to be treated for at least 48 hours before being enrolled in the study
- Clinically significant abnormal findings at screening (Visit 1), based on the Investigator's assessment.
- A hematocrit >54% or a hemoglobin >17 g/dL
Show all 26Show fewer
- Clinically significant abnormal laboratory findings at baseline (Visit 2), based on the Investigator's assessment
- 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)
- Abnormal fundoscopy exam such as central retinal vein occlusion
- 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
- Subjects with a Z-score of <2
- Hyperparathyroidism, metabolic bone disease, previous fracture of the spine, recent chemotherapy, use of medications that may influence BMD (thyroid replacement therapy, immunosuppressive therapy, prednisone or antiepileptic drugs
- No intravenous or oral contrast agents within 7 days.
- Subject weighs >300 pounds (>136 kg)
- 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
- History of drug abuse or chronic narcotic use including methadone
- Subjects with known history of HIV and/or Hepatitis C
- Subjects with end stage renal disease
- Subjects with cystic fibrosis (mutation of the CFTR gene)
- Enrollment in a previous Androxal study
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
United States17 sites
Study site
Clearwater, Florida, 33761
Study site
Fort Lauderdale, Florida, 33308
Study site
Henderson, Nevada, 89052
Study site
Houston, Texas, 77030
Study site
Jupiter, Florida, 33458
Study site
Lawrenceville, New Jersey, 08690
Study site
Mesa, Arizona, 85213
Study site
Miami, Florida, 33143
Study site
Miami Gardens, Florida, 33169
Study site
Mission Viejo, California, 92691
Study site
New York, New York, 10016
Study site
Newport Beach, California, 92663
Study site
Phoenix, Arizona, 85050
Study site
Rancho Cucamonga, California, 91730
Study site
Rochester, New York, 14609
Study site
Salt Lake City, Utah, 84124
Study site
Tempe, Arizona, 85283
About this study
Official title: A 12 Month, Single Blind, Placebo Controlled, Phase III Study to Assess the Effects of Enclomiphene Citrate Treatment On Bone Mineral Density in Men With Secondary Hypogonadism
To determine the effects of 12 months of treatment with Androxal on bone mineral density in men with secondary hypogonadism.
Read the detailed description
This study is a phase III single-blind placebo-controlled safety study with a 52 week active dosing period with Androxal. Safety will be assessed by physical and visual acuity exams, slit lamp and fundoscopy eye exams, clinical laboratory tests, DEXA scanning, lean soft tissue assessment (LST), and adverse event reporting. Results will be compared to an age-matched placebo group.
- Being tested
- enclomiphene citrate, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
enclomiphene citrateDrug
Also called Androxal
12.5 mg, 1 capsule, daily, oral. After 6 weeks of treatment, subjects will remain on 12.5 mg/day if their morning testosterone level is greater than 300 ng/dL. If a subject's testosterone is less than 300 ng/dL, the subject's dose will be increased to 25 mg/day
PlaceboDrug
1 placebo capsule per day, oral
| Study group | Role | What they receive |
|---|---|---|
| Androxal | Experimental | Not described Receives: Drug: enclomiphene citrate |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone Mineral Density
Change in bome mineral density at the end of study compared to placebo
Measured: 52 weeks
Secondary outcomes (1)
Testosterone
Changes of values from baseline in total morning Testosterone levels at week 52.
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2012 (estimated)
- Study startSep 2012
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Effect of Treatment on Bone Mineral DensityStudies 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
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Repros Therapeutics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01619683
- Sponsor's protocol ID
- ZA-303
- Status last verified
- Sep 2014
- First submitted
- 12 Jun 2012
- Last updated
- 1 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 12 Month, Single Blind, Placebo Controlled, Phase III Study to Assess the Effects of Enclomiphene Citrate Treatment On Bone Mineral Density in Men With Secondary Hypogonadism
- ClinicalTrials.gov ID
- NCT01619683
- Acronym / sponsor ID
- ZA-303
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Repros Therapeutics Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2012
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 14 Jun 2012 (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.
To determine the effects of 12 months of treatment with Androxal on bone mineral density in men with secondary hypogonadism.
Detailed description
This study is a phase III single-blind placebo-controlled safety study with a 52 week active dosing period with Androxal. Safety will be assessed by physical and visual acuity exams, slit lamp and fundoscopy eye exams, clinical laboratory tests, DEXA scanning, lean soft tissue assessment (LST), and adverse event reporting. Results will be compared to an age-matched placebo group.
Study design
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Androxal | Experimental | Drug: enclomiphene citrate |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Overweight (BMI 25 to 42 kg/m2 inclusive, or BMI 23 to 42 inclusive in Asian subjects) males age 18 to 60 inclusive
- 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 <300ng/dL measured twice on separate days. One of the two TT levels must be confirmed at baseline. Subjects who fail this criterion will be enrolled in the placebo group.
- LH <9.4 mIU/mL (at Visit 1 only)
Key exclusion criteria (26 listed)
- Use of an injectable or pelleted testosterone within 6 months prior to study (men currently on topical products may be enrolled in the study after a 7-day washout period)
- Use of 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 or diabetes mellitus based on the Investigator's assessment at baseline. Subjects treated for Type II diabetes will be allowed into the study. Newly diagnosed diabetics need to be treated for at least 48 hours before being enrolled in the study
- Clinically significant abnormal findings at screening (Visit 1), based on the Investigator's assessment.
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 |
|---|---|---|
| enclomiphene citrateAlso: Androxal12.5 mg, 1 capsule, daily, oral. After 6 weeks of treatment, subjects will remain on 12.5 mg/day if their morning testosterone level is greater than 300 ng/dL. If a subject's testosterone is less than 300 ng/dL, the subject's dose will be increased to 25 mg/day | Drug | Androxal |
| Placebo1 placebo capsule per day, oral | Drug | Placebo |
Primary outcome
Bone Mineral Density
Time frame: 52 weeks
Change in bome mineral density at the end of study compared to placebo
1 secondary outcome
Testosterone
Time frame: 52 weeks
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 1 Oct 2014.
- Sponsor's corporate web 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.
The record lists no contact. Use the official record to reach the sponsor.
17 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 enclomiphene citrate in people with Effect of Treatment on Bone Mineral Density, run by Repros Therapeutics Inc. at 17 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 26 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 1 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 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?
Bone Mineral Density (time frame: 52 weeks). 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 1 Oct 2014.