Trial Outcomes & Findings for Estrogen Sensitivity and Ovulatory Dysfunction in Obesity (NCT NCT01381016)
NCT ID: NCT01381016
Last Updated: 2015-04-20
Results Overview
The study is powered on luteinizing hormone pulse amplitude because it is the clinical outcome for which the most data is available. The primary comparison is whether there is a significant reduction in the pulse amplitude in the obese between the pre- and post-treatment periods and whether there is no change in the pulse amplitude in the normal weight patients between the pre and post-treatment periods.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
30 participants
Primary outcome timeframe
Baseline
Results posted on
2015-04-20
Participant Flow
Participant milestones
| Measure |
Control
Group 1 "Control": Normal weight (BMI 18-25 kg/m2)
Estradiol, Lutrelef or gonadorelin
|
Experimental
Group 2 "Experimental": Obese (BMI \>30 kg/m2)
Estradiol, Lutrelef or gonadorelin
|
|---|---|---|
|
Overall Study
STARTED
|
13
|
17
|
|
Overall Study
COMPLETED
|
10
|
11
|
|
Overall Study
NOT COMPLETED
|
3
|
6
|
Reasons for withdrawal
| Measure |
Control
Group 1 "Control": Normal weight (BMI 18-25 kg/m2)
Estradiol, Lutrelef or gonadorelin
|
Experimental
Group 2 "Experimental": Obese (BMI \>30 kg/m2)
Estradiol, Lutrelef or gonadorelin
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
|
Overall Study
Screen Failure
|
2
|
2
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
|
Overall Study
Physician Decision
|
0
|
2
|
Baseline Characteristics
Estrogen Sensitivity and Ovulatory Dysfunction in Obesity
Baseline characteristics by cohort
| Measure |
Control
n=13 Participants
Group 1 "Control": Normal weight (BMI 18-25 kg/m2)
Estradiol, Lutrelef or gonadorelin
|
Experimental
n=17 Participants
Group 2 "Experimental": Obese (BMI \>30 kg/m2)
Estradiol, Lutrelef or gonadorelin
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
13 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
29 years
n=5 Participants
|
31.76 years
n=7 Participants
|
30.57 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
13 participants
n=5 Participants
|
17 participants
n=7 Participants
|
30 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: BaselineThe study is powered on luteinizing hormone pulse amplitude because it is the clinical outcome for which the most data is available. The primary comparison is whether there is a significant reduction in the pulse amplitude in the obese between the pre- and post-treatment periods and whether there is no change in the pulse amplitude in the normal weight patients between the pre and post-treatment periods.
Outcome measures
| Measure |
Group 1 - Normal Weight
n=10 Participants
Group 1: Normal weight (BMI 18-25 kg/m2)
Estradiol, Lutrelef or gonadorelin
|
Group 2 - Obese
n=11 Participants
Group 2: Obese (BMI \>30 kg/m2)
Estradiol, Lutrelef or gonadorelin
|
|---|---|---|
|
Luteinizing Hormone Pulse Amplitude
|
2.73 IU/L
Standard Error .46
|
1.12 IU/L
Standard Error .19
|
PRIMARY outcome
Timeframe: Post estradiol at one monthOutcome measures
| Measure |
Group 1 - Normal Weight
n=10 Participants
Group 1: Normal weight (BMI 18-25 kg/m2)
Estradiol, Lutrelef or gonadorelin
|
Group 2 - Obese
n=11 Participants
Group 2: Obese (BMI \>30 kg/m2)
Estradiol, Lutrelef or gonadorelin
|
|---|---|---|
|
Luteinizing Hormone Pulse Amplitude
|
2.18 IU/L
Standard Error .4
|
1.59 IU/L
Standard Error .29
|
Adverse Events
Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Experimental
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Control
n=11 participants at risk
Group 1 "Control": Normal weight (BMI 18-25 kg/m2)
Estradiol, Lutrelef or gonadorelin
|
Experimental
n=15 participants at risk
Group 2 "Experimental": Obese (BMI \>30 kg/m2)
Estradiol, Lutrelef or gonadorelin
|
|---|---|---|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy
|
0.00%
0/11
2/13 subjects enrolled as controls were considered screen failures, thus only 11 subjects were considered participants "at risk" in the control group. 2/17 subjects enrolled in experimental group were considered screen failures, thus only 15 subjects were considered participants "at risk" in the experimental group.
|
6.7%
1/15 • Number of events 1
2/13 subjects enrolled as controls were considered screen failures, thus only 11 subjects were considered participants "at risk" in the control group. 2/17 subjects enrolled in experimental group were considered screen failures, thus only 15 subjects were considered participants "at risk" in the experimental group.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place