Trial Outcomes & Findings for Prevention of Obesity in Women Via Estradiol Regulation (NCT NCT00687739)
NCT ID: NCT00687739
Last Updated: 2025-04-01
Results Overview
Resting energy expenditure measured by indirect calorimeter at baseline and after 5 months of treatment.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
79 participants
Primary outcome timeframe
Before and after 5 months of treatment
Results posted on
2025-04-01
Participant Flow
Participant milestones
| Measure |
GnRH Agonist + Placebo
GnRH agonist + placebo
leuprolide acetate: 3.75 mg for depot suspension delivered by monthly intramuscular injection for 5 months
|
GnRH Agonist + Placebo + Exercise
GnRH agonist + placebo + exercise
leuprolide acetate: 3.75 mg for depot suspension delivered by monthly intramuscular injection for 5 months
progressive resistance exercise training: 45 minute exercise sessions 4 times per week for 5 months
|
GnRH Agonist + Estradiol
GnRH agonist + Estradiol
leuprolide acetate: 3.75 mg for depot suspension delivered by monthly intramuscular injection for 5 months
Estradiol Transdermal: 0.075 mg patch per day for 5 months
|
GnRH Agonist + Estradiol + Exercise
GnRH agonist + Estradiol + exercise
leuprolide acetate: 3.75 mg for depot suspension delivered by monthly intramuscular injection for 5 months
Estradiol Transdermal: 0.075 mg patch per day for 5 months
progressive resistance exercise training: 45 minute exercise sessions 4 times per week for 5 months
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
25
|
15
|
25
|
14
|
|
Overall Study
COMPLETED
|
23
|
12
|
23
|
12
|
|
Overall Study
NOT COMPLETED
|
2
|
3
|
2
|
2
|
Reasons for withdrawal
| Measure |
GnRH Agonist + Placebo
GnRH agonist + placebo
leuprolide acetate: 3.75 mg for depot suspension delivered by monthly intramuscular injection for 5 months
|
GnRH Agonist + Placebo + Exercise
GnRH agonist + placebo + exercise
leuprolide acetate: 3.75 mg for depot suspension delivered by monthly intramuscular injection for 5 months
progressive resistance exercise training: 45 minute exercise sessions 4 times per week for 5 months
|
GnRH Agonist + Estradiol
GnRH agonist + Estradiol
leuprolide acetate: 3.75 mg for depot suspension delivered by monthly intramuscular injection for 5 months
Estradiol Transdermal: 0.075 mg patch per day for 5 months
|
GnRH Agonist + Estradiol + Exercise
GnRH agonist + Estradiol + exercise
leuprolide acetate: 3.75 mg for depot suspension delivered by monthly intramuscular injection for 5 months
Estradiol Transdermal: 0.075 mg patch per day for 5 months
progressive resistance exercise training: 45 minute exercise sessions 4 times per week for 5 months
|
|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
2
|
1
|
2
|
|
Overall Study
Adverse Event
|
0
|
1
|
1
|
0
|
Baseline Characteristics
Prevention of Obesity in Women Via Estradiol Regulation
Baseline characteristics by cohort
| Measure |
GnRH Agonist + Placebo
n=23 Participants
GnRH agonist + placebo
leuprolide acetate: 3.75 mg for depot suspension delivered by monthly intramuscular injection for 5 months
|
GnRH Agonist + Placebo + Exercise
n=12 Participants
GnRH agonist + placebo + exercise
leuprolide acetate: 3.75 mg for depot suspension delivered by monthly intramuscular injection for 5 months
progressive resistance exercise training: 45 minute exercise sessions 4 times per week for 5 months
|
GnRH Agonist + Estradiol
n=23 Participants
GnRH agonist + Estradiol
leuprolide acetate: 3.75 mg for depot suspension delivered by monthly intramuscular injection for 5 months
Estradiol Transdermal: 0.075 mg patch per day for 5 months
|
GnRH Agonist + Estradiol + Exercise
n=12 Participants
GnRH agonist + Estradiol + exercise
leuprolide acetate: 3.75 mg for depot suspension delivered by monthly intramuscular injection for 5 months
Estradiol Transdermal: 0.075 mg patch per day for 5 months
progressive resistance exercise training: 45 minute exercise sessions 4 times per week for 5 months
|
Total
n=70 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
36 years
STANDARD_DEVIATION 8 • n=99 Participants
|
36 years
STANDARD_DEVIATION 8 • n=107 Participants
|
35 years
STANDARD_DEVIATION 9 • n=206 Participants
|
35 years
STANDARD_DEVIATION 9 • n=157 Participants
|
35.5 years
STANDARD_DEVIATION 8.5 • n=390 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
23 Participants
n=206 Participants
|
12 Participants
n=157 Participants
|
70 Participants
n=390 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=157 Participants
|
0 Participants
n=390 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=157 Participants
|
2 Participants
n=390 Participants
|
|
Race/Ethnicity, Customized
Native American
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=157 Participants
|
1 Participants
n=390 Participants
|
|
Race/Ethnicity, Customized
Black
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
2 Participants
n=157 Participants
|
9 Participants
n=390 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
15 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
17 Participants
n=206 Participants
|
9 Participants
n=157 Participants
|
50 Participants
n=390 Participants
|
|
Race/Ethnicity, Customized
More than one race
|
4 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=157 Participants
|
6 Participants
n=390 Participants
|
|
Race/Ethnicity, Customized
Refused to answer
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
0 Participants
n=157 Participants
|
2 Participants
n=390 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
4 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
2 Participants
n=157 Participants
|
9 Participants
n=390 Participants
|
|
Region of Enrollment
United States
|
23 participants
n=99 Participants
|
12 participants
n=107 Participants
|
23 participants
n=206 Participants
|
12 participants
n=157 Participants
|
70 participants
n=390 Participants
|
|
Body Mass Index (BMI)
|
28 kg/m^2
STANDARD_DEVIATION 6 • n=99 Participants
|
28 kg/m^2
STANDARD_DEVIATION 6 • n=107 Participants
|
28 kg/m^2
STANDARD_DEVIATION 6 • n=206 Participants
|
28 kg/m^2
STANDARD_DEVIATION 6 • n=157 Participants
|
28 kg/m^2
STANDARD_DEVIATION 6 • n=390 Participants
|
|
Body Composition Total Mass
|
74.4 kilograms
STANDARD_DEVIATION 2.7 • n=99 Participants
|
74.4 kilograms
STANDARD_DEVIATION 2.7 • n=107 Participants
|
76.6 kilograms
STANDARD_DEVIATION 3 • n=206 Participants
|
76.6 kilograms
STANDARD_DEVIATION 3 • n=157 Participants
|
75.5 kilograms
STANDARD_DEVIATION 2.8 • n=390 Participants
|
|
Body Composition Fat Mass
|
27.8 kilograms
STANDARD_DEVIATION 1.9 • n=99 Participants
|
27.8 kilograms
STANDARD_DEVIATION 1.9 • n=107 Participants
|
28.2 kilograms
STANDARD_DEVIATION 2 • n=206 Participants
|
28.2 kilograms
STANDARD_DEVIATION 2 • n=157 Participants
|
28 kilograms
STANDARD_DEVIATION 2 • n=390 Participants
|
PRIMARY outcome
Timeframe: Before and after 5 months of treatmentPopulation: Participants who completed 24-h visits in the room calorimeter before and after the intervention. This could not be accomplished in all participants in the trial because of scheduling difficulties and/or lack of availability of the calorimeter. The primary analysis was by drug group only (placebo vs estradiol), collapsed across exercise grouping.
Resting energy expenditure measured by indirect calorimeter at baseline and after 5 months of treatment.
Outcome measures
| Measure |
GnRHag+PL
n=16 Participants
GnRH agonist + placebo
leuprolide acetate: 3.75 mg for depot suspension delivered by monthly intramuscular injection for 5 months
|
GnRHag+PL+ex
n=8 Participants
GnRH agonist + placebo + exercise
leuprolide acetate: 3.75 mg for depot suspension delivered by monthly intramuscular injection for 5 months
progressive resistance exercise training: 45 minute exercise sessions 4 times per week for 5 months
|
GnRHag+E2
n=16 Participants
GnRH agonist + Estradiol
leuprolide acetate: 3.75 mg for depot suspension delivered by monthly intramuscular injection for 5 months
Estradiol Transdermal: 0.075 mg patch per day for 5 months
|
GnRHag+E2+ex
n=8 Participants
GnRH agonist + Estradiol + exercise
leuprolide acetate: 3.75 mg for depot suspension delivered by monthly intramuscular injection for 5 months
Estradiol Transdermal: 0.075 mg patch per day for 5 months
progressive resistance exercise training: 45 minute exercise sessions 4 times per week for 5 months
|
|---|---|---|---|---|
|
Resting Energy Expenditure (REE)
|
-37.8 kcal/d
Interval -88.7 to 13.0
|
-87.2 kcal/d
Interval -185.9 to 11.4
|
14.6 kcal/d
Interval -34.8 to 64.0
|
-19.3 kcal/d
Interval -95.1 to 56.4
|
PRIMARY outcome
Timeframe: Before and after 5 months of treatmentPopulation: Women who completed the DEX/CRH stimulation test before and after the intervention. The Outcome Measure evaluation was only conducted in a subgroup of women - those in the Drug intervention arms. This evaluation was not done in the exercise arms.
Cortisol response to corticotropin releasing hormone (CRH) during dexamethasone (DEX) suppression; DEX/CRH stimulation test
Outcome measures
| Measure |
GnRHag+PL
n=15 Participants
GnRH agonist + placebo
leuprolide acetate: 3.75 mg for depot suspension delivered by monthly intramuscular injection for 5 months
|
GnRHag+PL+ex
n=15 Participants
GnRH agonist + placebo + exercise
leuprolide acetate: 3.75 mg for depot suspension delivered by monthly intramuscular injection for 5 months
progressive resistance exercise training: 45 minute exercise sessions 4 times per week for 5 months
|
GnRHag+E2
GnRH agonist + Estradiol
leuprolide acetate: 3.75 mg for depot suspension delivered by monthly intramuscular injection for 5 months
Estradiol Transdermal: 0.075 mg patch per day for 5 months
|
GnRHag+E2+ex
GnRH agonist + Estradiol + exercise
leuprolide acetate: 3.75 mg for depot suspension delivered by monthly intramuscular injection for 5 months
Estradiol Transdermal: 0.075 mg patch per day for 5 months
progressive resistance exercise training: 45 minute exercise sessions 4 times per week for 5 months
|
|---|---|---|---|---|
|
Cortisol Response (Area Under the Curve) to CRH Under DEX Suppression
|
189 ng/mL x min
Interval -2481.0 to 2859.0
|
-3115 ng/mL x min
Interval -5322.0 to -907.0
|
—
|
—
|
SECONDARY outcome
Timeframe: Before and after 5 months of treatmentPopulation: Participants who completed 24-h visits in the room calorimeter before and after the intervention
24-hour energy expenditure measured by indirect calorimetry in a room calorimeter
Outcome measures
| Measure |
GnRHag+PL
n=16 Participants
GnRH agonist + placebo
leuprolide acetate: 3.75 mg for depot suspension delivered by monthly intramuscular injection for 5 months
|
GnRHag+PL+ex
n=8 Participants
GnRH agonist + placebo + exercise
leuprolide acetate: 3.75 mg for depot suspension delivered by monthly intramuscular injection for 5 months
progressive resistance exercise training: 45 minute exercise sessions 4 times per week for 5 months
|
GnRHag+E2
n=16 Participants
GnRH agonist + Estradiol
leuprolide acetate: 3.75 mg for depot suspension delivered by monthly intramuscular injection for 5 months
Estradiol Transdermal: 0.075 mg patch per day for 5 months
|
GnRHag+E2+ex
n=8 Participants
GnRH agonist + Estradiol + exercise
leuprolide acetate: 3.75 mg for depot suspension delivered by monthly intramuscular injection for 5 months
Estradiol Transdermal: 0.075 mg patch per day for 5 months
progressive resistance exercise training: 45 minute exercise sessions 4 times per week for 5 months
|
|---|---|---|---|---|
|
Total Energy Expenditure (TEE)
|
-108.8 kcal/d
Interval -201.1 to -16.5
|
-166.5 kcal/d
Interval -388.1 to 55.1
|
-92.7 kcal/d
Interval -167.1 to -18.4
|
-107.4 kcal/d
Interval -298.3 to 83.5
|
SECONDARY outcome
Timeframe: Before and after 5 months of treatmentTotal body fat mass measured by DXA
Outcome measures
| Measure |
GnRHag+PL
n=23 Participants
GnRH agonist + placebo
leuprolide acetate: 3.75 mg for depot suspension delivered by monthly intramuscular injection for 5 months
|
GnRHag+PL+ex
n=12 Participants
GnRH agonist + placebo + exercise
leuprolide acetate: 3.75 mg for depot suspension delivered by monthly intramuscular injection for 5 months
progressive resistance exercise training: 45 minute exercise sessions 4 times per week for 5 months
|
GnRHag+E2
n=23 Participants
GnRH agonist + Estradiol
leuprolide acetate: 3.75 mg for depot suspension delivered by monthly intramuscular injection for 5 months
Estradiol Transdermal: 0.075 mg patch per day for 5 months
|
GnRHag+E2+ex
n=12 Participants
GnRH agonist + Estradiol + exercise
leuprolide acetate: 3.75 mg for depot suspension delivered by monthly intramuscular injection for 5 months
Estradiol Transdermal: 0.075 mg patch per day for 5 months
progressive resistance exercise training: 45 minute exercise sessions 4 times per week for 5 months
|
|---|---|---|---|---|
|
Fat Mass
|
0.5 kg
Interval -0.5 to 1.4
|
-0.6 kg
Interval -1.7 to 0.5
|
0.4 kg
Interval -0.7 to 1.5
|
-0.8 kg
Interval -2.9 to 1.2
|
SECONDARY outcome
Timeframe: Before and after 5 months of treatmentPopulation: Participants who completed outcome measurements before and after the interention
Total body fat-free mass measured by DXA
Outcome measures
| Measure |
GnRHag+PL
n=23 Participants
GnRH agonist + placebo
leuprolide acetate: 3.75 mg for depot suspension delivered by monthly intramuscular injection for 5 months
|
GnRHag+PL+ex
n=12 Participants
GnRH agonist + placebo + exercise
leuprolide acetate: 3.75 mg for depot suspension delivered by monthly intramuscular injection for 5 months
progressive resistance exercise training: 45 minute exercise sessions 4 times per week for 5 months
|
GnRHag+E2
n=23 Participants
GnRH agonist + Estradiol
leuprolide acetate: 3.75 mg for depot suspension delivered by monthly intramuscular injection for 5 months
Estradiol Transdermal: 0.075 mg patch per day for 5 months
|
GnRHag+E2+ex
n=12 Participants
GnRH agonist + Estradiol + exercise
leuprolide acetate: 3.75 mg for depot suspension delivered by monthly intramuscular injection for 5 months
Estradiol Transdermal: 0.075 mg patch per day for 5 months
progressive resistance exercise training: 45 minute exercise sessions 4 times per week for 5 months
|
|---|---|---|---|---|
|
Fat-free Mass
|
-1.0 kg
Interval -1.5 to -0.6
|
0.1 kg
Interval -0.6 to 0.7
|
0.0 kg
Interval -0.5 to 0.4
|
1.0 kg
Interval -0.3 to 2.2
|
Adverse Events
GnRH Agonist + Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
GnRH Agonist + Placebo + Exercise
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
GnRH Agonist + Estradiol
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
GnRH Agonist + Estradiol + Exercise
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
GnRH Agonist + Placebo
n=23 participants at risk
GnRH agonist + placebo
leuprolide acetate: 3.75 mg for depot suspension delivered by monthly intramuscular injection for 5 months
|
GnRH Agonist + Placebo + Exercise
n=12 participants at risk
GnRH agonist + placebo + exercise
leuprolide acetate: 3.75 mg for depot suspension delivered by monthly intramuscular injection for 5 months
progressive resistance exercise training: 45 minute exercise sessions 4 times per week for 5 months
|
GnRH Agonist + Estradiol
n=23 participants at risk
GnRH agonist + Estradiol
leuprolide acetate: 3.75 mg for depot suspension delivered by monthly intramuscular injection for 5 months
Estradiol Transdermal: 0.075 mg patch per day for 5 months
|
GnRH Agonist + Estradiol + Exercise
n=12 participants at risk
GnRH agonist + Estradiol + exercise
leuprolide acetate: 3.75 mg for depot suspension delivered by monthly intramuscular injection for 5 months
Estradiol Transdermal: 0.075 mg patch per day for 5 months
progressive resistance exercise training: 45 minute exercise sessions 4 times per week for 5 months
|
|---|---|---|---|---|
|
Product Issues
Hospitalization
|
0.00%
0/23 • Adverse events were collected from the time eligibility was established through the completion of the study, over approximately 1 year.
Adverse events were queried every 4 weeks.
|
0.00%
0/12 • Adverse events were collected from the time eligibility was established through the completion of the study, over approximately 1 year.
Adverse events were queried every 4 weeks.
|
4.3%
1/23 • Number of events 1 • Adverse events were collected from the time eligibility was established through the completion of the study, over approximately 1 year.
Adverse events were queried every 4 weeks.
|
0.00%
0/12 • Adverse events were collected from the time eligibility was established through the completion of the study, over approximately 1 year.
Adverse events were queried every 4 weeks.
|
Other adverse events
Adverse event data not reported
Additional Information
Wendy M Kohrt, PhD
University of Colorado Anschutz Medical Campus
Phone: 3037241913
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place