Change in Total Morning Testosterone
| Group | Value (ng/dL) | Spread |
|---|---|---|
| Placebo | -16.9 | 47.5 |
| Testim (Topical Testosterone) | 253.7 | 292.3 |
| Androxal 12.5 mg | 258.5 | 201.5 |
| Androxal 25 mg | 197.3 | 162.6 |
Trial · Interventional
CompletedPhase 2Results postedRegistry dataUnited States
1 trial · 1 completed · 1 with posted results
Normalization of Morning Testosterone Levels in Men With Secondary Hypogonadism
NCT01270841Jan 2011 to Dec 2011
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
The Purpose of the study is to determine the effects of Androxal on morning testosterone and reproductive status in men with secondary hypogonadism(confirmed morning Testosterone less than 250 ng/dL), compared to changes with placebo, or Testim (topical testosterone). The effects of Testim versus placebo on reproductive status will also be examined. Study subjects must not be currently using a topical testosterone.
Placebo comparator
Placebo
Placebo
Active comparator
Testim (topical testosterone)
Testim (topical testosterone)
Experimental
Androxal 12.5 mg
Androxal 12.5 mg/day
Experimental
Androxal 25 mg
Androxal 25 mg/day
Outcomes the sponsor listed as primary.
Change in Total Morning Testosterone
Time frame · 3 months
Changes in values from baseline in total morning testosterone levels at month 3 comparing Androxal 12.5 and 25 mg to placebo and Testim
Change in Luteinizing Hormone Levels
Time frame · 3 months
Changes in values from baseline in LH at month 3
Change in FSH After 3 Months of Treatment
Time frame · 3 months
Reproductive Safety
Time frame · 3 months
Change from baseline in sperm concentration
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
| Group | Value (ng/dL) | Spread |
|---|---|---|
| Placebo | -16.9 | 47.5 |
| Testim (Topical Testosterone) | 253.7 | 292.3 |
| Androxal 12.5 mg | 258.5 | 201.5 |
| Androxal 25 mg | 197.3 | 162.6 |
| Group | Value (mIU/mL) | Spread |
|---|---|---|
| Placebo | -0.1 | 1.0 |
| Testim (Topical Testosterone) | -2.4 | 2.4 |
| Androxal 12.5 mg | 4.8 | 4.7 |
| Androxal 25 mg | 6.9 | 7.7 |
| Group | Value (mIU/mL) | Spread |
|---|---|---|
| Placebo | -0.2 | 0.7 |
| Testim (Topical Testosterone) | -4.4 | 2.9 |
| Androxal 12.5 mg | 5.1 | 6.2 |
| Androxal 25 mg | 7.4 | 6.5 |
| Group | Value (millions/mL) | Spread |
|---|---|---|
| Placebo | -19.1 | 93.4 |
| Testim (Topical Testosterone) | -29.5 | 39.0 |
| Androxal 12.5 mg | 8.2 | 233.1 |
| Androxal 25 mg | -2.8 | 167.0 |
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| PlaceboPlacebo Placebo: Placebo capsule 1x daily for 3 months | – | 0 / 28 | 3 / 28 |
| Testim (Topical Testosterone)Testim (topical testosterone) topical testosterone: testosterone gel applied 1x daily for 3 months | – | 1 / 33 | 15 / 33 |
| Androxal 12.5 mgAndroxal 12.5 mg/day Androxal: Capsule of either 12.5 mg or 25 mg Androxal, 1x daily for 3 months | – | 0 / 27 | 3 / 27 |
| Androxal 25 mgAndroxal 25 mg/day Androxal: Capsule of either 12.5 mg or 25 mg Androxal, 1x daily for 3 months | – | 0 / 33 | 3 / 33 |
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
Studies that cite this trial.
1 study on this page
Indexing hint: Randomized controlled trial · 2014
Wiehle et al. 2014Fertility and sterilitycited by 49
PMID 25044085DOI 10.1016/j.fertnstert.2014.06.004PUB-25044085
Who could join, as posted.
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