Trial Outcomes & Findings for Reproductive Hormonal Alterations in Obesity (NCT NCT01457703)
NCT ID: NCT01457703
Last Updated: 2017-01-12
Results Overview
Luteinizing Hormone (LH) Pulse Amplitude was measured hourly during the 12 hour study visit, and was compared between the obese and normal weight groups.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
62 participants
Primary outcome timeframe
Measured hourly and averaged over the 12 hour study visit
Results posted on
2017-01-12
Participant Flow
Participant milestones
| Measure |
BMI ≥30 kg/m2
* BMI ≥30 kg/m2
* History of regular menstrual cycles every 25-40 days
Letrozole, Gonadorelin-GnRH, Luveris-lutropin, cetrorelix: Reproductive Hormonal Alterations in Obesity, Aims #1 and 2" Description: comparative study of pathophysiology
|
BMI 18-25 kg/m2
* BMI 18-25 kg/m2
* History of regular menstrual cycles every 25-35 days
Letrozole, Gonadorelin-GnRH, Luveris-lutropin, cetrorelix: Reproductive Hormonal Alterations in Obesity, Aims #1 and 2" Description: comparative study of pathophysiology
|
|---|---|---|
|
Overall Study
STARTED
|
29
|
33
|
|
Overall Study
COMPLETED
|
23
|
22
|
|
Overall Study
NOT COMPLETED
|
6
|
11
|
Reasons for withdrawal
| Measure |
BMI ≥30 kg/m2
* BMI ≥30 kg/m2
* History of regular menstrual cycles every 25-40 days
Letrozole, Gonadorelin-GnRH, Luveris-lutropin, cetrorelix: Reproductive Hormonal Alterations in Obesity, Aims #1 and 2" Description: comparative study of pathophysiology
|
BMI 18-25 kg/m2
* BMI 18-25 kg/m2
* History of regular menstrual cycles every 25-35 days
Letrozole, Gonadorelin-GnRH, Luveris-lutropin, cetrorelix: Reproductive Hormonal Alterations in Obesity, Aims #1 and 2" Description: comparative study of pathophysiology
|
|---|---|---|
|
Overall Study
Screen Failure
|
5
|
7
|
|
Overall Study
Withdrawal by Subject
|
1
|
4
|
Baseline Characteristics
Reproductive Hormonal Alterations in Obesity
Baseline characteristics by cohort
| Measure |
BMI ≥30 kg/m2
n=29 Participants
* BMI ≥30 kg/m2
* History of regular menstrual cycles every 25-40 days
Letrozole, Gonadorelin-GnRH, Luveris-lutropin, cetrorelix: Reproductive Hormonal Alterations in Obesity, Aims #1 and 2" Description: comparative study of pathophysiology
|
BMI 18-25 kg/m2
n=33 Participants
* BMI 18-25 kg/m2
* History of regular menstrual cycles every 25-35 days
Letrozole, Gonadorelin-GnRH, Luveris-lutropin, cetrorelix: Reproductive Hormonal Alterations in Obesity, Aims #1 and 2" Description: comparative study of pathophysiology
|
Total
n=62 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
|
29 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
62 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Gender
Female
|
29 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
62 Participants
n=5 Participants
|
|
Gender
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
24 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
8 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
15 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
29 participants
n=5 Participants
|
33 participants
n=7 Participants
|
62 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Measured hourly and averaged over the 12 hour study visitPopulation: This study was divided into two aims, and 10 obese and 10 normal weight women completed the study procedures and contributed data for analyses related to Aim 1.
Luteinizing Hormone (LH) Pulse Amplitude was measured hourly during the 12 hour study visit, and was compared between the obese and normal weight groups.
Outcome measures
| Measure |
BMI ≥30 kg/m2
n=10 Participants
* BMI ≥30 kg/m2
* History of regular menstrual cycles every 25-40 days
Letrozole, Gonadorelin-GnRH, Luveris-lutropin, cetrorelix: Reproductive Hormonal Alterations in Obesity, Aims #1 and 2" Description: comparative study of pathophysiology
|
BMI 18-25 kg/m2
n=10 Participants
* BMI 18-25 kg/m2
* History of regular menstrual cycles every 25-35 days
Letrozole, Gonadorelin-GnRH, Luveris-lutropin, cetrorelix: Reproductive Hormonal Alterations in Obesity, Aims #1 and 2" Description: comparative study of pathophysiology
|
|---|---|---|
|
Changes in Luteinizing Hormone (LH) Pulse Amplitude (Aim 1)
|
4.1 IU/L
Interval 2.9 to 5.2
|
3.6 IU/L
Interval 2.7 to 9.9
|
PRIMARY outcome
Timeframe: Measured hourly and averaged over the 12 hour study visitPopulation: This study was divided into two aims, and only 12 obese and 11 normal weight women completed the study procedures for Aim 2 that allowed measure of LH pulse amplitude.
Luteinizing Hormone (LH) Pulse Amplitude was measured hourly during the 12 hour study visit, and was compared between the obese and normal weight groups.
Outcome measures
| Measure |
BMI ≥30 kg/m2
n=12 Participants
* BMI ≥30 kg/m2
* History of regular menstrual cycles every 25-40 days
Letrozole, Gonadorelin-GnRH, Luveris-lutropin, cetrorelix: Reproductive Hormonal Alterations in Obesity, Aims #1 and 2" Description: comparative study of pathophysiology
|
BMI 18-25 kg/m2
n=11 Participants
* BMI 18-25 kg/m2
* History of regular menstrual cycles every 25-35 days
Letrozole, Gonadorelin-GnRH, Luveris-lutropin, cetrorelix: Reproductive Hormonal Alterations in Obesity, Aims #1 and 2" Description: comparative study of pathophysiology
|
|---|---|---|
|
Changes in Luteinizing Hormone (LH) Pulse Amplitude (Aim 2)
|
2.21 IU/L
Standard Deviation .32
|
4.44 IU/L
Standard Deviation 1.03
|
PRIMARY outcome
Timeframe: Averaged over the length of menstrual cyclePopulation: This study was divided into two aims, and only 12 obese and 10 normal weight women completed the urine collection study procedures for Aim 2 that allowed measure of PdG.
Pregnanediol glucuronide (PdG) was collected daily over the course of one menstrual cycle and averaged.
Outcome measures
| Measure |
BMI ≥30 kg/m2
n=12 Participants
* BMI ≥30 kg/m2
* History of regular menstrual cycles every 25-40 days
Letrozole, Gonadorelin-GnRH, Luveris-lutropin, cetrorelix: Reproductive Hormonal Alterations in Obesity, Aims #1 and 2" Description: comparative study of pathophysiology
|
BMI 18-25 kg/m2
n=10 Participants
* BMI 18-25 kg/m2
* History of regular menstrual cycles every 25-35 days
Letrozole, Gonadorelin-GnRH, Luveris-lutropin, cetrorelix: Reproductive Hormonal Alterations in Obesity, Aims #1 and 2" Description: comparative study of pathophysiology
|
|---|---|---|
|
Changes in Pregnanediol Glucuronide (PdG) (Aim 2)
|
54.1 ug/cycle
Standard Deviation 33
|
88.7 ug/cycle
Standard Deviation 64.6
|
SECONDARY outcome
Timeframe: Measured hourly and averaged over the 12 hour study visitPopulation: This study was divided into two aims, and only 10 obese and 10 normal weight women completed the study procedures for Aim 1 that allowed measure of FSH.
Follicle-stimulating hormone was measured hourly during the 12 hour study visit, and was compared between the obese and normal weight groups.
Outcome measures
| Measure |
BMI ≥30 kg/m2
n=10 Participants
* BMI ≥30 kg/m2
* History of regular menstrual cycles every 25-40 days
Letrozole, Gonadorelin-GnRH, Luveris-lutropin, cetrorelix: Reproductive Hormonal Alterations in Obesity, Aims #1 and 2" Description: comparative study of pathophysiology
|
BMI 18-25 kg/m2
n=10 Participants
* BMI 18-25 kg/m2
* History of regular menstrual cycles every 25-35 days
Letrozole, Gonadorelin-GnRH, Luveris-lutropin, cetrorelix: Reproductive Hormonal Alterations in Obesity, Aims #1 and 2" Description: comparative study of pathophysiology
|
|---|---|---|
|
Changes in Follicle Stimulating Hormone (FSH) (Aim 1)
|
3.8 IU/L
Interval 2.1 to 4.2
|
3.3 IU/L
Interval 3.0 to 4.9
|
SECONDARY outcome
Timeframe: Measured hourly and averaged over the 12 hour study visitPopulation: This study was divided into two aims, and only 12 obese and 11 normal weight women completed the study procedures for Aim 2 that allowed measure of FSH.
Follicle-stimulating hormone was measured hourly during the 12 hour study visit, and was compared between the obese and normal weight groups.
Outcome measures
| Measure |
BMI ≥30 kg/m2
n=12 Participants
* BMI ≥30 kg/m2
* History of regular menstrual cycles every 25-40 days
Letrozole, Gonadorelin-GnRH, Luveris-lutropin, cetrorelix: Reproductive Hormonal Alterations in Obesity, Aims #1 and 2" Description: comparative study of pathophysiology
|
BMI 18-25 kg/m2
n=11 Participants
* BMI 18-25 kg/m2
* History of regular menstrual cycles every 25-35 days
Letrozole, Gonadorelin-GnRH, Luveris-lutropin, cetrorelix: Reproductive Hormonal Alterations in Obesity, Aims #1 and 2" Description: comparative study of pathophysiology
|
|---|---|---|
|
Changes in Follicle Stimulating Hormone (FSH) (Aim 2)
|
5.31 IU/L
Standard Deviation .38
|
6.18 IU/L
Standard Deviation .94
|
Adverse Events
BMI ≥30 kg/m2
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
BMI 18-25 kg/m2
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Clinical Research Regulatory Manager
University of Colorado Denver
Phone: 303-724-6501
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place