Proportion (Percentage) of Androxal Treated Subjects With Testosterone in the Normal Range
| Group | Value (Percentage of Subjects) |
|---|---|
| Androxal Treated Subjects Pooled | 78.8 |
Trial · Interventional
CompletedPhase 3Results postedRegistry dataUnited States
1 trial · 1 completed · 1 with posted results
Phase III Study to Evaluated Morning Testosterone Normalization in Men With Secondary Hypogonadism
NCT01532414Aug 2012 to Mar 2013
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
The purpose of ZA-301 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.
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
Outcomes the sponsor listed as primary.
Proportion (Percentage) of Androxal Treated Subjects With Testosterone in the Normal Range
Time frame · 3 months
Proportion of pooled Androxal subjects with average serum concentration (Cavg) for T in the normal range (300 - 1040 ng/dL) after 12 weeks of treatment. Cavg will be 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 co-primary endpoint based on the Cavg for testosterone has 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.
Subjects With 50% or Greater Decrease in Sperm Concentration Comparison of Proportion of Subjects With 50% or Greater Decrease in Sperm
Time frame · 3 months
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.
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
| Group | Value (Percentage of Subjects) |
|---|---|
| Androxal Treated Subjects Pooled | 78.8 |
| Group | Value (percentage of participants) |
|---|---|
| Androxal Subjects Pooled | 14.2 |
| Placebo | 2.6 |
| Group | Deaths | Serious events | Other 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 | – | 0 / 92 | 5 / 92 |
| Androxal 25 mgAndroxal (enclomiphene citrate), 25 mg oral capsules taken once daily enclomiphene citrate: oral, capsules, taken one time daily, for 3 months | – | 0 / 21 | 6 / 21 |
| PlaceboPlacebo oral capsules taken one time daily Placebo: Oral capsule taken one time daily for 3 months | – | 0 / 38 | 4 / 38 |
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