Change in Physical Activity Energy Expenditure (PAEE)
| Group | Value (kcal/day) | Spread |
|---|---|---|
| Placebo | 74.5 | 77.9 |
| GnRH Agonist | -10.2 | 63.6 |
| GnRH Agonist + Exercise | 61.0 | 66.4 |
Trial · Interventional
CompletedNot applicableResults postedRegistry dataShort name FAME
United States
1 trial · 1 completed · 1 with posted results
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
This study is designed to determine whether a reduction in hormones (such as occurs during menopause) causes a decrease in calories burned during physical activity. This study will also determine whether a reduction in hormones decreases calories burned while sleeping, resting, and eating and whether an exercise intervention can prevent this.
Placebo comparator
Placebo
Monthly placebo injections for 6 months
Active comparator
GnRH agonist
Monthly GnRH agonist injections for 6 months
Active comparator
GnRH agonist + exercise
Monthly GnRH agonist injections for 6 months plus supervised cardiovascular exercise intervention
Outcomes the sponsor listed as primary.
Change in Physical Activity Energy Expenditure (PAEE)
Time frame · Change from baseline to 6 months
PAEE will be calculated as: TEE - REE - TEF, where TEE is total energy expenditure (measured by doubly-labeled water), REE is resting energy expenditure (measured by indirect calorimetry), and TEF is the thermic effect of feeding (estimated using a constant).
Total Fat Mass
Time frame · Change over 6 months
Total Fat mass as measured by DXA
Total Fat Free Mass
Time frame · Change over 6 months
Total Fat Free Mass as measured by DXA
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
| Group | Value (kcal/day) | Spread |
|---|---|---|
| Placebo | 74.5 | 77.9 |
| GnRH Agonist | -10.2 | 63.6 |
| GnRH Agonist + Exercise | 61.0 | 66.4 |
| Group | Value (kg) | Spread |
|---|---|---|
| Placebo | 0.73 | 0.68 |
| GnRH Agonist | 1.66 | 0.41 |
| GnRH Agonist + Exercise | 0.89 | 0.60 |
| Group | Value (kg) | Spread |
|---|---|---|
| Placebo | 0.1 | 0.34 |
| GnRH Agonist | -0.69 | 0.34 |
| GnRH Agonist + Exercise | -0.66 | 0.59 |
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| PlaceboMonthly placebo injections for 6 months Placebo: Placebo | 0 / 10 | 0 / 10 | 3 / 10 |
| GnRH AgonistMonthly GnRH agonist injections for 6 months GnRH agonist: Drug: leuprolide acetate Other Names: Lupron 3.75 mg for depot suspension delivered by monthly intramuscular injection for 6 months | 0 / 14 | 0 / 14 | 4 / 14 |
| GnRH Agonist + ExerciseMonthly GnRH agonist injections for 6 months plus supervised cardiovascular exercise intervention GnRH agonist: Drug: leuprolide acetate Other Names: Lupron 3.75 mg for depot suspension delivered by monthly intramuscular injection for 6 months Supervised cardiovascular exercise: Supervised exercise, 4 days per week for 45 to 60 minutes per session for 6 months | 0 / 18 | 0 / 18 | 4 / 18 |
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