Trial Outcomes & Findings for Pilot of Letrozole for Uterine Myomas (NCT NCT02470741)
NCT ID: NCT02470741
Last Updated: 2019-11-15
Results Overview
The Uterine Fibroid Sympton and Quality of Life (UFS-QoL) Symptom Severity score measures self-reported severity of fibroid-related symptoms. Symptoms include: fatigue, sleep, self-image, mood disturbances/psychologic distress, fear of embarrassment, interference with daily activities, relationships with family and friends, and sexual functioning. Scores range from 0 to 100; higher scores indicate greater symptom severity.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
12 participants
Primary outcome timeframe
Baseline to 2 Months
Results posted on
2019-11-15
Participant Flow
Participant milestones
| Measure |
Letrozole
Oral letrozole 2.5mg/day
|
Placebo and Letrozole
Intermittent oral letrozole 2.5mg/day for 2 months and an identical placebo capsule for 4 months
|
|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
|
Overall Study
COMPLETED
|
3
|
4
|
|
Overall Study
NOT COMPLETED
|
3
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pilot of Letrozole for Uterine Myomas
Baseline characteristics by cohort
| Measure |
Letrozole
n=6 Participants
Oral letrozole 2.5mg/day
|
Placebo and Letrozole
n=6 Participants
Intermittent oral letrozole 2.5mg/day for 2 months and an identical placebo capsule for 4 months
|
Total
n=12 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
46.33 years
STANDARD_DEVIATION 4.2 • n=5 Participants
|
39.50 years
STANDARD_DEVIATION 7.4 • n=7 Participants
|
42.92 years
STANDARD_DEVIATION 6.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White or Caucasian
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latina
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian/Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
More than one race reported
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
UFS-QOL Symptom Severity Score
|
53.65 units on a scale
STANDARD_DEVIATION 25.00 • n=5 Participants
|
42.71 units on a scale
STANDARD_DEVIATION 9.0 • n=7 Participants
|
48.18 units on a scale
STANDARD_DEVIATION 18.8 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to 2 MonthsPopulation: The final analysis excludes one participant in the placebo/letrozole group who dropped out of the study after baseline but prior to starting study medication and the Month 2 visit.
The Uterine Fibroid Sympton and Quality of Life (UFS-QoL) Symptom Severity score measures self-reported severity of fibroid-related symptoms. Symptoms include: fatigue, sleep, self-image, mood disturbances/psychologic distress, fear of embarrassment, interference with daily activities, relationships with family and friends, and sexual functioning. Scores range from 0 to 100; higher scores indicate greater symptom severity.
Outcome measures
| Measure |
Letrozole
n=6 Participants
Oral letrozole 2.5mg/day
|
Placebo and Letrozole
n=5 Participants
Intermittent oral letrozole 2.5mg/day for 2 months and an identical placebo capsule for 4 months
|
|---|---|---|
|
Changes in Fibroid-related Symptoms After Treatment With Letrozole
|
-10.42 units on a scale
Interval -24.63 to 3.97
|
1.43 units on a scale
Interval -14.14 to 16.99
|
Adverse Events
Letrozole
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Placebo and Letrozole
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Letrozole
n=6 participants at risk
Oral letrozole 2.5mg/day
|
Placebo and Letrozole
n=6 participants at risk
Intermittent oral letrozole 2.5mg/day for 2 months and an identical placebo capsule for 4 months
|
|---|---|---|
|
General disorders
Dizziness/Light-headedness
|
16.7%
1/6 • Number of events 1 • 7 months. Adverse Events were collected beginning at Baseline until 1 month after study completion.
|
0.00%
0/6 • 7 months. Adverse Events were collected beginning at Baseline until 1 month after study completion.
|
|
Renal and urinary disorders
Pelvic pressure increasing urination
|
16.7%
1/6 • Number of events 1 • 7 months. Adverse Events were collected beginning at Baseline until 1 month after study completion.
|
0.00%
0/6 • 7 months. Adverse Events were collected beginning at Baseline until 1 month after study completion.
|
|
Reproductive system and breast disorders
Bleeding between periods
|
16.7%
1/6 • Number of events 1 • 7 months. Adverse Events were collected beginning at Baseline until 1 month after study completion.
|
0.00%
0/6 • 7 months. Adverse Events were collected beginning at Baseline until 1 month after study completion.
|
|
Psychiatric disorders
Irritable
|
0.00%
0/6 • 7 months. Adverse Events were collected beginning at Baseline until 1 month after study completion.
|
16.7%
1/6 • Number of events 1 • 7 months. Adverse Events were collected beginning at Baseline until 1 month after study completion.
|
|
Reproductive system and breast disorders
Pain in uterus
|
0.00%
0/6 • 7 months. Adverse Events were collected beginning at Baseline until 1 month after study completion.
|
16.7%
1/6 • Number of events 1 • 7 months. Adverse Events were collected beginning at Baseline until 1 month after study completion.
|
|
Skin and subcutaneous tissue disorders
Oily skin
|
0.00%
0/6 • 7 months. Adverse Events were collected beginning at Baseline until 1 month after study completion.
|
16.7%
1/6 • Number of events 1 • 7 months. Adverse Events were collected beginning at Baseline until 1 month after study completion.
|
|
Vascular disorders
Hot flashes/night sweats
|
0.00%
0/6 • 7 months. Adverse Events were collected beginning at Baseline until 1 month after study completion.
|
16.7%
1/6 • Number of events 1 • 7 months. Adverse Events were collected beginning at Baseline until 1 month after study completion.
|
|
Gastrointestinal disorders
Stomach aches
|
0.00%
0/6 • 7 months. Adverse Events were collected beginning at Baseline until 1 month after study completion.
|
16.7%
1/6 • Number of events 1 • 7 months. Adverse Events were collected beginning at Baseline until 1 month after study completion.
|
|
Musculoskeletal and connective tissue disorders
Muscle or joint pain/strain
|
0.00%
0/6 • 7 months. Adverse Events were collected beginning at Baseline until 1 month after study completion.
|
16.7%
1/6 • Number of events 1 • 7 months. Adverse Events were collected beginning at Baseline until 1 month after study completion.
|
|
Reproductive system and breast disorders
Cyst
|
0.00%
0/6 • 7 months. Adverse Events were collected beginning at Baseline until 1 month after study completion.
|
16.7%
1/6 • Number of events 1 • 7 months. Adverse Events were collected beginning at Baseline until 1 month after study completion.
|
Additional Information
Lisa Abinanti, Project Director
University of California, San Francisco
Phone: 415-353-9978
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place