24 Hour Average and Maximum Testosterone Concentration
| Group | Value (ng/dL) | Spread |
|---|---|---|
| Androxal 6.25 mg | 262.3 | 80.3 |
| Androxal 12.5 mg | 373.6 | 172.1 |
| Androxal 25 mg | 298.3 | 100.5 |
| AndroGel | 322.4 | 102.9 |
Trial · Interventional
CompletedPhase 2Results postedRegistry dataUnited States
1 trial · 1 completed · 1 with posted results
The Effect on Androxal Versus Androgel on Morning Testosterone in Men With Secondary Hypogonadism (Low Testosterone)
NCT01386606Jun 2011 to Oct 2011
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
The study will determine the effects of three doses of Androxal(enclomiphene citrate)on morning testosterone versus AndroGel(approved topical treatment)in men with low testosterone (\<350 ng/dL)after 6 weeks of continuous dosing.
Experimental
Androxal 6.25 mg
Androxal 6.25 mg/day
Experimental
Androxal 12.5 mg
Androxal 12.5 mg/day
Experimental
Androxal 25 mg
Androxal 25 mg/day
Active comparator
AndroGel
AndroGel 5G topical testosterone
Outcomes the sponsor listed as primary.
24 Hour Average and Maximum Testosterone Concentration
Time frame · Baseline and Week 6
The primary efficacy endpoint will be 24-hour average (TTavg) and maximum (TTmax) testosterone concentration compared to baseline after 6 weeks of treatment. Time points (in hours after dosing) at which testosterone concentration was measured are: 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24.
Change in Leuteinizing Hormone (LH)
Time frame · Baseline, Week 2, Week 4, Week 6
Changes in morning LH after continuous dosing
Change in Follicle Stimulating Hormone (FSH)
Time frame · Baseline, Week 2, Week 4, Week 6
Changes in morning FSH after continuous dosing
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 6.25 mg | 262.3 | 80.3 |
| Androxal 12.5 mg | 373.6 | 172.1 |
| Androxal 25 mg | 298.3 | 100.5 |
| AndroGel | 322.4 | 102.9 |
| Group | Value (mIU/mL) | Spread |
|---|---|---|
| Androxal 6.25 mg | 3.63 | 1.55 |
| Androxal 12.5 mg | 4.82 | 1.63 |
| Androxal 25 mg | 4.98 | 3.45 |
| AndroGel | 3.57 | 2.23 |
| Group | Value (Number of Subjects) |
|---|---|
| Androxal Pooled Dose Levels | 35 |
| Group | Value (ng/mL) | Spread |
|---|---|---|
| Androxal 6.25 mg | 1.8154 | 0.8358 |
| Androxal 12.5 mg | 3.3899 | 2.0239 |
| Androxal 25 mg | 16.2993 | 12.8952 |
| Group | Value (mIU/mL) | Spread |
|---|---|---|
| Androxal 6.25 mg | 4.61 | 1.97 |
| Androxal 12.5 mg | 5.63 | 2.26 |
| Androxal 25 mg | 6.31 | 4.28 |
| AndroGel | 6.38 | 2.79 |
| Group | Value (h) | Spread |
|---|---|---|
| Androxal 6.25 mg | 2.33 | 0.98 |
| Androxal 12.5 mg | 2.42 | 1.21 |
| Androxal 25 mg | 2.41 | 1.48 |
| Group | Value (ng*h/mL) | Spread |
|---|---|---|
| Androxal 6.25 mg | 21.200 | 14.399 |
| Androxal 12.5 mg | 34.012 | 21.419 |
| Androxal 25 mg | 150.51 | 132.32 |
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Androxal 6.25 mgenclomiphene citrate: capsule oral 1X a day 6 weeks | – | 0 / 16 | 2 / 16 |
| Androxal 12.5 mgenclomiphene citrate: capsule oral 1X a day 6 weeks | – | 0 / 14 | 1 / 14 |
| Androxal 25 mgenclomiphene citrate: capsule oral 1X a day 6 weeks | – | 0 / 16 | 1 / 16 |
| AndroGelAndroGel 5G topical testosterone Testosterone: topical gel 1X a day 6 weeks | – | 0 / 14 | 4 / 14 |
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