Percent Change in Free Testosterone (T)
| Group | Value (percent change) | Spread |
|---|---|---|
| Metformin | -6.9 | 22.8 |
| Leuprolide | -35.8 | 31.8 |
| Placebo | 12.1 | 17.8 |
Trial · Interventional
CompletedPhase 2Results postedRegistry dataUnited States
1 trial · 1 completed · 1 with posted results
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
The purpose of this research study is to determine if a relationship between insulin resistance (IR) and testosterone (T) exists in women who have already gone through menopause.
Experimental
1
metformin pill plus placebo injection
Experimental
2
leuprolide injection plus placebo pill
Placebo comparator
3
placebo pill plus placebo injection
Outcomes the sponsor listed as primary.
Percent Change in Free Testosterone (T)
Time frame · Baseline to 12 weeks
Percent change in free T by equilibrium dialysis between baseline and 12 weeks
Change in Insulin Sensitivity
Time frame · baseline and 12 weeks
Change in insulin sensitivity (mg/kg/min) calculated from hyperinsulinemic euglycemic clamp
Percent Change in Luteinizing Hormone (LH) From Baseline
Time frame · baseline and 12 weeks
Percent Change in Homeostasis Model Assessment Index of Insulin Resistance (HOMA-IR)
Time frame · baseline and 12 weeks
Insulin resistance calculated from homeostasis model assessment of insulin resistance (HOMA-IR) equation: fasting insulin x fasting glucose / 405. Higher values indicate more insulin resistance.
Percent Change in Low Density Lipoprotein (LDL)
Time frame · baseline and 12 weeks
Percent Change in Systolic Blood Pressure
Time frame · baseline and 12 weeks
Free T and IR in Women in Whom Metabolic Syndrome is Present vs. Absent
Time frame · baseline and 12 weeks
Dehydroepiandrosterone Sulfate (DHEA-S)
Time frame · baseline and 12 weeks
Body Mass Index (BMI)
Time frame · baseline and 12 weeks
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
| Group | Value (percent change) | Spread |
|---|---|---|
| Metformin | -6.9 | 22.8 |
| Leuprolide | -35.8 | 31.8 |
| Placebo | 12.1 | 17.8 |
| Group | Value (mg/kg/min) | Spread |
|---|---|---|
| Metformin | 0.44 | 0.80 |
| Leuprolide | 0.04 | 0.81 |
| Placebo | -0.08 | 0.73 |
| Group | Value (percent change) |
|---|---|
| Metformin | 4.6 |
| Leuprolide | -96.5 |
| Placebo | -1.2 |
| Group | Value (percent change) | Spread |
|---|---|---|
| Metformin | -31.0 | 24.39 |
| Leuprolide | -8.18 | 35.3 |
| Placebo | 4.67 | 38.16 |
| Group | Value (percent change) | Spread |
|---|---|---|
| Metformin | -10.8 | 22.2 |
| Leuprolide | 5.3 | 19.3 |
| Placebo | 25.3 | 50.8 |
| Group | Value (percent change) | Spread |
|---|---|---|
| Metformin | -4.2 | 8.6 |
| Leuprolide | 4.0 | 13.6 |
| Placebo | -0.3 | 8.6 |
| Group | Value |
|---|---|
| Metformin | not posted |
| Leuprolide | not posted |
| Placebo | not posted |
| Group | Value (percent change) |
|---|---|
| Metformin | 2.6 |
| Leuprolide | 0.9 |
| Placebo | -2.9 |
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Metforminmetformin plus leuprolide placebo (LP) injection | 0 / 12 | 0 / 12 | 0 / 12 |
| Leuprolideleuprolide plus metformin placebo (MP) pill | 0 / 12 | 0 / 12 | 0 / 12 |
| PlaceboMP placebo pill plus LP placebo injection | 0 / 11 | 0 / 11 | 0 / 11 |
Each cell reads participants affected / participants at risk, as the registry posted them.
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