Change From Baseline in Total Morning Testosterone at 26 Weeks
| Group | Value (ng/dL) | Spread |
|---|---|---|
| Androxal 12.5 mg | 280.9 | 141.4 |
| Androxal 25 mg | 214.7 | 154.7 |
Trial · Interventional
CompletedPhase 3Results postedRegistry dataUnited States
1 trial · 1 completed · 1 with posted results
Safety Study of Enclomiphene Citrate in the Treatment of Men With Secondary Hypogonadism
NCT01534208May 2012 to Oct 2013
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
ZA-300 is meant to determine the safety profile of Androxal (enclomiphene citrate) in men with secondary hypogonadism.
Experimental
Androxal 12.5 mg
Androxal 12.5 mg daily
Experimental
Androxal 25 mg
Androxal 25 mg daily
Outcomes the sponsor listed as primary.
Change From Baseline in Total Morning Testosterone at 26 Weeks
Time frame · 6 months
Changes in values from baseline of total morning testosterone levels at Week 26
Change From Baseline in LH
Time frame · 6 months
Mean change from baseline in LH at end of treatment (26 weeks)
Absolute Values of Morning Testosterone
Time frame · 6 months
Absolute values of morning testosterone at end of treatment (26 weeks)
Mean Change From Baseline FPG
Time frame · 6 months
Mean changes in Fasting Plasma Glucose from baseline to end of treatment (26 weeks)
Change From Baseline in BMI
Time frame · 6 months
Mean change from baseline in BMI at end of treatment (26 weeks)
Change From Baseline in FSH
Time frame · 6 months
Change from baseline in FSH at end of treatment (26 weeks)
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
| Group | Value (ng/dL) | Spread |
|---|---|---|
| Androxal 12.5 mg | 280.9 | 141.4 |
| Androxal 25 mg | 214.7 | 154.7 |
| Group | Value (mIu/mL) | Spread |
|---|---|---|
| Androxal 12.5 mg | 4.81 | 5.69 |
| Androxal 25 mg | 4.27 | 4.29 |
| Group | Value (ng/dL) | Spread |
|---|---|---|
| Androxal 12.5 mg | 511.6 | 140.8 |
| Androxal 25 mg | 416.7 | 154.7 |
| Group | Value (mg/dL) | Spread |
|---|---|---|
| Androxal 12.5 mg | -5.4 | 30.8 |
| Androxal 25 mg | -5.0 | 29.3 |
| Group | Value (kg/m2) | Spread |
|---|---|---|
| Androxal 12.5 mg | 0.2 | 1.4 |
| Androxal 25 mg | 0.3 | 1.1 |
| Group | Value (U/L) | Spread |
|---|---|---|
| Androxal 12.5 mg | 5.20 | 5.19 |
| Androxal 25 mg | 5.42 | 5.48 |
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Androxal 12.5 mgAndroxal 12.5 mg daily Androxal: Androxal, oral, 12.5 mg capsule, taken once daily. Dose may be increased from 12.5 mg to 25 mg if indicated | – | 6 / 207 | 66 / 207 |
| Androxal 25 mgAndroxal 25 mg daily Androxal: Androxal, oral, 12.5 mg capsule, taken once daily. Dose may be increased from 12.5 mg to 25 mg if indicated | – | 9 / 283 | 92 / 283 |
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