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Trial · Interventional

CompletedPhase 3Results postedRegistry data

Phase III Study to Evaluate Morning Testosterone Normalization in Overweight Men With Secondary Hypogonadism

Overview

Status
Completed
Phase
Phase 3
Enrollment
181 participants (actual)
Sponsor
Repros Therapeutics Inc. · Industry
Design
Randomized · Double masking
Countries
1 country

United States

Start
Nov 2012
Primary completion
Sept 2013
Completion
Sept 2013
First posted
3 Dec 2012 (estimated)
Last update posted
27 May 2015 (estimated)
Conditions
Secondary Hypogonadism

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
201220132014
  1. Ph 3

    Phase III Study to Evaluate Morning Testosterone Normalization in Overweight Men With Secondary Hypogonadism

    NCT01739595

    Nov 2012 to Sept 2013

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

The purpose of ZA-302 is to determine the effects of Androxal on morning testosterone and reproductive status in younger overweight men with acquired hypogonadotropic hypogonadism (confirmed morning T\<300 ng/dL) and normal sperm concentration, compared to changes with placebo. Subjects must not have previously been treated with testosterone products within the last 6 months.

Interventions

  • enclomiphene citrateDrug
  • PlaceboDrug

Arms3

  • Experimental

    Androxal 12.5 mg

    Androxal (enclomiphene citrate), 12.5 mg oral capsules taken once daily

  • Experimental

    Androxal 25 mg

    Androxal (enclomiphene citrate), 25 mg oral capsules taken once daily

  • Placebo comparator

    Placebo

    Placebo oral capsules taken one time daily

Primary outcomes2

Outcomes the sponsor listed as primary.

  1. Subjects With Testosterone in Normal Range After Treatment

    Time frame · 3 months

    Registry description

    Proportion (percent) of subjects with average serum concentration (Cavg) for T in the normal range (300 - 1040 ng/dL) after 12 weeks of treatment. Cavg was calculated as the numerical average of 24-hour serial testosterone assessments at 0, 1, 2, 3, 4, 6, 8, 12, 16 and 24 hours after dosing. If the lower limit of the 95% confidence interval for the Androxal treatment group at Week 12 is at least 67%, then the coprimary endpoint based on the Cavg for testosterone would have been achieved. FDA specified primary endpoint did not include comparison to placebo, thus the proportion of placebo subjects with average serum concentration (Cavg) for T in the normal range (300 - 1040 ng/dL) after 12 weeks of treatment was not calculated.

  2. Change in Sperm Concentration

    Time frame · 3 months

    Registry description

    Proportion of subjects with a 50% or greater decrease in sperm concentration from baseline after 12 weeks of treatment in Androxal treated subjects to placebo. The difference between the proportions (placebo minus Androxal) and corresponding 95% confidence interval was determined and compared to the equivalence limit of -20%. If the lower limit of the 95% confidence interval was greater than -20%, then Androxal would be concluded to be non-inferior to placebo in causing a 50% reduction in sperm concentrations.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeNumber· 3 months

Subjects With Testosterone in Normal Range After Treatment

GroupValue (Percentage of Subjects)
Androxal Subjects Pooled81.3
Primary outcomeNumber· 3 months

Change in Sperm Concentration

GroupValue (percentage of subjects)
Androxal Subjects Pooled14.2
Placebo4.3

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Androxal 12.5 mgAndroxal (enclomiphene citrate), 12.5 mg oral capsules taken once daily enclomiphene citrate: oral, capsules, taken one time daily, for 3 months–1 / 11221 / 112
Androxal 25 mgAndroxal (enclomiphene citrate), 25 mg oral capsules taken once daily enclomiphene citrate: oral, capsules, taken one time daily, for 3 months–0 / 2216 / 22
PlaceboPlacebo oral capsules taken one time daily Placebo: Oral capsule taken one time daily for 3 months–0 / 4710 / 47

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
Male
Age
from 18 Years up to 60 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: 1. Overweight (BMI 25 to 42 kg/m2 inclusive) males age 18 to 60 inclusive 2. All clinical laboratory tests within normal ranges (any clinically significant deviation of laboratory results will require approval of sponsor) 3. Previously or concurrently diagnosed as having secondary hypogonadism characterized as having 2 consecutive morning testosterone assessments \< 300ng/dL, one of which must be confirmed at Baseline. 4. LH \< 9.4 mIU/mL (at Visit 1 only) 5. Sperm count ≥ 15 million per milliliter (assessed twice at least 48 hours apart) 6. Ability to complete the study in compliance with the protocol 7. Ability to understand and provide written informed consent 8. Agreement to provide a total of up to 6 semen sample in a sponsor-approved clinic on up to 6 separate occasions. Exclusion Criteria: 1. Any prior use of testosterone treatments within the last 6 months 2. Use of spironolactone, cimetidine, Clomid, 5α-reductase inhibitors, hCG, androgen, estrogen, anabolic steroid, DHEA, or herbal hormone products during the study 3. Use of Clomid in the past year 4. 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. 5. Clinically significant abnormal findings at Screening (Visit 1) or Baseline, based on the Investigator's assessment 6. A hematocrit \>54% or a hemoglobin \>17 g/dL (sponsor may approve enrollment of subjects with hemoglobin up to 17.5 g/dL if the subject is at a location with a high elevation) 7. 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. 8. Known hypersensitivity to Clomid 9. Symptomatic cataracts (nuclear sclerosis cataract or cortical cataract grade \> 2 based on 0-4 scale or any trace of posterior subcapsular cataract) 10. Abnormal fundoscopy exam such as central retinal vein occlusion 11. 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 12. Irreversibly infertile or compromised fertility (cryptorchism, Kallman Syndrome, primary hypogonadism, vasectomy, or tumors of the pituitary) 13. Current or history of breast cancer 14. Current or history of prostate cancer or a suspicion of prostate disease unless ruled out by prostate biopsy, or a PSA\>3.6 15. Presence or history of known hyperprolactinemia with or without a tumor 16. Chronic use of medications such as glucocorticoids 17. History of drug abuse or chronic narcotic use including methadone 18. A recent history of alcoholism or illegal substance or steroid abuse (\<2 years) or presence of moderate alcohol use (\>21 drinks per week) 19. Subjects with known history of HIV and/or Hepatitis C 20. Subjects with end stage renal disease 21. History of liver disease (including malignancy) or a confirmed AST or ALT \>3 times the upper limit of normal 22. History of myocardial infarction, unstable angina, symptomatic heart failure, ventricular dysrhythmia or know history of QTc interval prolongation 23. History of cerebrovascular disease 24. History of venous thromboembolic disease (e.g. deep vein thrombosis or pulmonary embolism) 25. History of erythrocytosis or polycythemia 26. Subjects with cystic fibrosis (mutation of the CFTR gene) 27. Subjects unable to provide a semen sample in a sponsor-approved clinic 28. Enrollment in a previous Androxal study

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