Trial Outcomes & Findings for Letrozole Treatment in Normal and GnRH Deficient Women (NCT NCT00351416)
NCT ID: NCT00351416
Last Updated: 2017-07-27
Results Overview
Difference in FSH peak following letrozole administration compared with control cycle
Recruitment status
UNKNOWN
Study phase
PHASE1/PHASE2
Target enrollment
15 participants
Primary outcome timeframe
EFP: average of menstrual cycle day 6 in the EFP; LFP: average of 2 days after follicle size of 16 mm
Results posted on
2017-07-27
Participant Flow
Four subjects did not meet inclusion criteria (2 had increased prolactin, 2 had abnormal cycles) and were excluded after screening and before assignment to treatment.
Participant milestones
| Measure |
Aromatase Inhibitor EFP
Letrozole administration (20 mg) on day 2-4 (EFP; early follicular phase) of cycle 2 and
Nal-Glu GnRH antagonist used to estimate the overall amount of GnRH secreted.
Letrozole: Letrozole 20 mg orally one time
NAL-GLU GnRH antagonist: 5 mcg/kg of the NAL-GLU GnRH antagonist subcutaneously
|
Aromatase Inhibitor LFP
Letrozole administration (20 mg daily x 2) at follicle size of \> 16 mm (LFP; late follicular phase) in cycle 2.
Nal-Glu GnRH antagonist used to estimate the overall amount of GnRH secreted.
Letrozole: Letrozole 20 mg orally one time
NAL-GLU GnRH antagonist: 5 mcg/kg of the NAL-GLU GnRH antagonist subcutaneously
|
|---|---|---|
|
Overall Study
STARTED
|
6
|
9
|
|
Overall Study
COMPLETED
|
6
|
9
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Letrozole Treatment in Normal and GnRH Deficient Women
Baseline characteristics by cohort
| Measure |
Aromatase Inhibitor EFP
n=6 Participants
Letrozole administration (20 mg) on day 2-4 (EFP; early follicular phase) of cycle 2 and
Nal-Glu GnRH antagonist used to estimate the overall amount of GnRH secreted.
Letrozole: Letrozole 20 mg orally one time
NAL-GLU GnRH antagonist: 5 mcg/kg of the NAL-GLU GnRH antagonist subcutaneously
|
Aromatase Inhibitor LFP
n=9 Participants
Letrozole administration (20 mg daily x 2) at follicle size of \> 16 mm (LFP; late follicular phase) in cycle 2.
Nal-Glu GnRH antagonist used to estimate the overall amount of GnRH secreted.
Letrozole: Letrozole 20 mg orally one time
NAL-GLU GnRH antagonist: 5 mcg/kg of the NAL-GLU GnRH antagonist subcutaneously
|
Total
n=15 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
27.2 years
STANDARD_DEVIATION 5 • n=93 Participants
|
28.5 years
STANDARD_DEVIATION 4.2 • n=4 Participants
|
27.9 years
STANDARD_DEVIATION 4.4 • n=27 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=93 Participants
|
9 Participants
n=4 Participants
|
15 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
13 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
12 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=93 Participants
|
9 participants
n=4 Participants
|
15 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: EFP: average of menstrual cycle day 6 in the EFP; LFP: average of 2 days after follicle size of 16 mmDifference in FSH peak following letrozole administration compared with control cycle
Outcome measures
| Measure |
Aromatase Inhibitor EFP
n=6 Participants
Letrozole administration (20 mg) on day 2-4 (EFP; early follicular phase) of cycle 2 and
Nal-Glu GnRH antagonist used to estimate the overall amount of GnRH secreted.
Letrozole: Letrozole 20 mg orally one time
NAL-GLU GnRH antagonist: 5 mcg/kg of the NAL-GLU GnRH antagonist subcutaneously
|
Aromatase Inhibitor LFP
n=9 Participants
Letrozole administration (20 mg daily x 2) at follicle size of \> 16 mm (LFP; late follicular phase) in cycle 2.
Nal-Glu GnRH antagonist used to estimate the overall amount of GnRH secreted.
Letrozole: Letrozole 20 mg orally one time
NAL-GLU GnRH antagonist: 5 mcg/kg of the NAL-GLU GnRH antagonist subcutaneously
|
|---|---|---|
|
FSH Level
|
7.25 IU/L
Standard Error 2.42
|
8.71 IU/L
Standard Error 1.58
|
Adverse Events
Aromatase Inhibitor EFP
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Aromatase Inhibitor LFP
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place