Trial Outcomes & Findings for Neurobiology of Bulimia Nervosa (NCT NCT04225221)
NCT ID: NCT04225221
Last Updated: 2022-07-26
Results Overview
Binge eating will be measured using the 8-item binge eating subscale of the Eating Pathology Symptoms Inventory (EPSI), which measures features of binge eating (e.g., consumption of large quantities of food, mindless eating) on a 5-point Likert scale from "never" to "very often." The EPSI scale is designed to assess behavior over the past 28 days; however, to be sensitive to the timeframe of the present study, the instructions will be modified to ask participants to consider the past week. Items are summed for a scale score ranging from 0-32. Higher scores indicate more frequent experiences with binge eating behavior. Change is defined by an average change score.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
10 participants
Primary outcome timeframe
Baseline (Day 14 of baseline) to End of Intervention (Day 14 of each intervention)
Results posted on
2022-07-26
Participant Flow
Participant milestones
| Measure |
Sequence A: Estradiol Followed by Progesterone
Participants are randomly assigned to treatment Sequence A: after achieving hormone suppression using Lupron, participants begin the addback period and take study medications for 8 weeks. During the 8 week period, participants will take placebo or estradiol or progesterone. Participants will not know when or for how long they are on active medication (i.e., estradiol or progesterone) or inactive (i.e., placebo) medication. When active medication is administered, participants randomized to treatment sequence A will receive estradiol addback first, followed by progesterone.
Estradiol and progesterone are never given simultaneously. Participants are on active medication for a total of 4 weeks.
Estradiol: During estradiol administration, 2mg of estradiol is given twice daily via oral capsule.
Micronized progesterone: During progesterone administration, 200mg of progesterone is given twice daily via oral capsule.
Leuprolide Acetate: Initial 3.75 mg intramuscular injection administered approximately Day 6 of menstrual cycle and then monthly thereafter for a total of 3 months.
Placebo Oral Capsule: Placebo is administered during the addback phase when participants are not taking active medication. Placebo is given so that medication administration occurs throughout the entire 8-week addback period in order to blind participants to when and for how long they are on the active medication.
|
Sequence B: Progesterone Followed by Estradiol
Participants are randomly assigned to treatment Sequence B: after achieving hormone suppression using Lupron, participants begin the addback period and take study medications for 8 weeks. During the 8 week period, participants will take placebo or estradiol or progesterone. Participants will not know when or for how long they are on active medication (i.e., estradiol or progesterone) or inactive (i.e., placebo) medication. When active medication is administered, participants randomized to treatment sequence B will receive progesterone first followed by estradiol.
Estradiol and progesterone are never given simultaneously. Participants are on active medication for a total of 4 weeks.
Estradiol: During estradiol administration, 2mg of estradiol is given twice daily via oral capsule.
Micronized progesterone: During progesterone administration, 200mg of progesterone is given twice daily via oral capsule.
Leuprolide Acetate: Initial 3.75 mg intramuscular injection administered approximately Day 6 of menstrual cycle and then monthly thereafter for a total of 3 months.
Placebo Oral Capsule: Placebo is administered during the addback phase when participants are not taking active medication. Placebo is given so that medication administration occurs throughout the entire 8-week addback period in order to blind participants to when and for how long they are on the active medication.
|
|---|---|---|
|
Lupron and Placebo Baseline (6 Weeks)
STARTED
|
6
|
4
|
|
Lupron and Placebo Baseline (6 Weeks)
COMPLETED
|
5
|
4
|
|
Lupron and Placebo Baseline (6 Weeks)
NOT COMPLETED
|
1
|
0
|
|
First Intervention (2 Weeks)
STARTED
|
6
|
4
|
|
First Intervention (2 Weeks)
COMPLETED
|
6
|
4
|
|
First Intervention (2 Weeks)
NOT COMPLETED
|
0
|
0
|
|
Washout (2 Weeks)
STARTED
|
5
|
4
|
|
Washout (2 Weeks)
COMPLETED
|
4
|
4
|
|
Washout (2 Weeks)
NOT COMPLETED
|
1
|
0
|
|
Second Intervention (2 Weeks)
STARTED
|
5
|
4
|
|
Second Intervention (2 Weeks)
COMPLETED
|
5
|
4
|
|
Second Intervention (2 Weeks)
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Neurobiology of Bulimia Nervosa
Baseline characteristics by cohort
| Measure |
Sequence A: Estradiol Followed by Progesterone
n=6 Participants
Participants are randomly assigned to treatment Sequence A: after achieving hormone suppression using Lupron, participants begin the addback period and take study medications for 8 weeks. During the 8 week period, participants will take placebo or estradiol or progesterone. Participants will not know when or for how long they are on active medication (i.e., estradiol or progesterone) or inactive (i.e., placebo) medication. When active medication is administered, participants randomized to treatment sequence A will receive estradiol addback first, followed by progesterone.
Estradiol and progesterone are never given simultaneously. Participants are on active medication for a total of 4 weeks.
Estradiol: During estradiol administration, 2mg of estradiol is given twice daily via oral capsule.
Micronized progesterone: During progesterone administration, 200mg of progesterone is given twice daily via oral capsule.
Leuprolide Acetate: Initial 3.75 mg intramuscular injection administered approximately Day 6 of menstrual cycle and then monthly thereafter for a total of 3 months.
Placebo Oral Capsule: Placebo is administered during the addback phase when participants are not taking active medication. Placebo is given so that medication administration occurs throughout the entire 8-week addback period in order to blind participants to when and for how long they are on the active medication.
|
Sequence B: Progesterone Followed by Estradiol
n=4 Participants
Participants are randomly assigned to treatment Sequence B: after achieving hormone suppression using Lupron, participants begin the addback period and take study medications for 8 weeks. During the 8 week period, participants will take placebo or estradiol or progesterone. Participants will not know when or for how long they are on active medication (i.e., estradiol or progesterone) or inactive (i.e., placebo) medication. When active medication is administered, participants randomized to treatment sequence B will receive progesterone first followed by estradiol.
Estradiol and progesterone are never given simultaneously. Participants are on active medication for a total of 4 weeks.
Estradiol: During estradiol administration, 2mg of estradiol is given twice daily via oral capsule.
Micronized progesterone: During progesterone administration, 200mg of progesterone is given twice daily via oral capsule.
Leuprolide Acetate: Initial 3.75 mg intramuscular injection administered approximately Day 6 of menstrual cycle and then monthly thereafter for a total of 3 months.
Placebo Oral Capsule: Placebo is administered during the addback phase when participants are not taking active medication. Placebo is given so that medication administration occurs throughout the entire 8-week addback period in order to blind participants to when and for how long they are on the active medication.
|
Total
n=10 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
26 Years
STANDARD_DEVIATION 7.5 • n=93 Participants
|
20 Years
STANDARD_DEVIATION 1.6 • n=4 Participants
|
24 Years
STANDARD_DEVIATION 6.5 • n=27 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
10 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
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
9 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
|
2 Participants
n=4 Participants
|
3 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
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
5 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
|
4 Participants
n=4 Participants
|
10 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Baseline (Day 14 of baseline) to End of Intervention (Day 14 of each intervention)Binge eating will be measured using the 8-item binge eating subscale of the Eating Pathology Symptoms Inventory (EPSI), which measures features of binge eating (e.g., consumption of large quantities of food, mindless eating) on a 5-point Likert scale from "never" to "very often." The EPSI scale is designed to assess behavior over the past 28 days; however, to be sensitive to the timeframe of the present study, the instructions will be modified to ask participants to consider the past week. Items are summed for a scale score ranging from 0-32. Higher scores indicate more frequent experiences with binge eating behavior. Change is defined by an average change score.
Outcome measures
| Measure |
Estradiol
n=10 Participants
Participants are randomly assigned to treatment Sequence A: after achieving hormone suppression using Lupron, participants begin the addback period and take study medications for 8 weeks. During the 8 week period, participants will take placebo or estradiol or progesterone. Participants will not know when or for how long they are on active medication (i.e., estradiol or progesterone) or inactive (i.e., placebo) medication. When active medication is administered, participants randomized to treatment sequence A will receive estradiol addback first, followed by progesterone.
Estradiol and progesterone are never given simultaneously. Participants are on active medication for a total of 4 weeks.
Estradiol: During estradiol administration, 2mg of estradiol is given twice daily via oral capsule.
Micronized progesterone: During progesterone administration, 200mg of progesterone is given twice daily via oral capsule.
Leuprolide Acetate: Initial 3.75 mg intramuscular injection administered approximately Day 6 of menstrual cycle and then monthly thereafter for a total of 3 months.
Placebo Oral Capsule: Placebo is administered during the addback phase when participants are not taking active medication. Placebo is given so that medication administration occurs throughout the entire 8-week addback period in order to blind participants to when and for how long they are on the active medication.
|
Progesterone
n=9 Participants
Participants are randomly assigned to treatment Sequence B: after achieving hormone suppression using Lupron, participants begin the addback period and take study medications for 8 weeks. During the 8 week period, participants will take placebo or estradiol or progesterone. Participants will not know when or for how long they are on active medication (i.e., estradiol or progesterone) or inactive (i.e., placebo) medication. When active medication is administered, participants randomized to treatment sequence B will receive progesterone first followed by estradiol.
Estradiol and progesterone are never given simultaneously. Participants are on active medication for a total of 4 weeks.
Estradiol: During estradiol administration, 2mg of estradiol is given twice daily via oral capsule.
Micronized progesterone: During progesterone administration, 200mg of progesterone is given twice daily via oral capsule.
Leuprolide Acetate: Initial 3.75 mg intramuscular injection administered approximately Day 6 of menstrual cycle and then monthly thereafter for a total of 3 months.
Placebo Oral Capsule: Placebo is administered during the addback phase when participants are not taking active medication. Placebo is given so that medication administration occurs throughout the entire 8-week addback period in order to blind participants to when and for how long they are on the active medication.
|
|---|---|---|
|
Change in Binge Eating Sum Score
|
-0.60 score on a scale
Standard Deviation 4.7
|
0.89 score on a scale
Standard Deviation 4.7
|
PRIMARY outcome
Timeframe: Baseline (Day 14 of baseline) to End of Intervention (Day 14 of each intervention)Binge eating frequency is based on a daily diary of self-reported binge eating frequency. Scores can range from 0 to infinity as they represent a self-reported frequency. Subjects self-report the number of binge eating episodes they had each day. Higher numbers indicate more frequent binge eating episodes. Average weekly frequency will be determined based on daily reported binge eating frequency. Change is defined by an average change score.
Outcome measures
| Measure |
Estradiol
n=10 Participants
Participants are randomly assigned to treatment Sequence A: after achieving hormone suppression using Lupron, participants begin the addback period and take study medications for 8 weeks. During the 8 week period, participants will take placebo or estradiol or progesterone. Participants will not know when or for how long they are on active medication (i.e., estradiol or progesterone) or inactive (i.e., placebo) medication. When active medication is administered, participants randomized to treatment sequence A will receive estradiol addback first, followed by progesterone.
Estradiol and progesterone are never given simultaneously. Participants are on active medication for a total of 4 weeks.
Estradiol: During estradiol administration, 2mg of estradiol is given twice daily via oral capsule.
Micronized progesterone: During progesterone administration, 200mg of progesterone is given twice daily via oral capsule.
Leuprolide Acetate: Initial 3.75 mg intramuscular injection administered approximately Day 6 of menstrual cycle and then monthly thereafter for a total of 3 months.
Placebo Oral Capsule: Placebo is administered during the addback phase when participants are not taking active medication. Placebo is given so that medication administration occurs throughout the entire 8-week addback period in order to blind participants to when and for how long they are on the active medication.
|
Progesterone
n=9 Participants
Participants are randomly assigned to treatment Sequence B: after achieving hormone suppression using Lupron, participants begin the addback period and take study medications for 8 weeks. During the 8 week period, participants will take placebo or estradiol or progesterone. Participants will not know when or for how long they are on active medication (i.e., estradiol or progesterone) or inactive (i.e., placebo) medication. When active medication is administered, participants randomized to treatment sequence B will receive progesterone first followed by estradiol.
Estradiol and progesterone are never given simultaneously. Participants are on active medication for a total of 4 weeks.
Estradiol: During estradiol administration, 2mg of estradiol is given twice daily via oral capsule.
Micronized progesterone: During progesterone administration, 200mg of progesterone is given twice daily via oral capsule.
Leuprolide Acetate: Initial 3.75 mg intramuscular injection administered approximately Day 6 of menstrual cycle and then monthly thereafter for a total of 3 months.
Placebo Oral Capsule: Placebo is administered during the addback phase when participants are not taking active medication. Placebo is given so that medication administration occurs throughout the entire 8-week addback period in order to blind participants to when and for how long they are on the active medication.
|
|---|---|---|
|
Change in Weekly Average Binge-eating Frequency
|
-0.48 episodes/week
Standard Deviation 2.6
|
1.1 episodes/week
Standard Deviation 4.7
|
PRIMARY outcome
Timeframe: Baseline (Day 14 of baseline) to End of Intervention (Day 14 of intervention)Sensitivity to Punishment/Sensitivity to Reward Questionnaire will be used to measure reward sensitivity during estradiol intervention. The reward sensitivity subscale will be used, which is rated on a true/false scale with scores ranging 0-24. Higher scores indicate more sensitivity to reward. Change is defined by an average change score.
Outcome measures
| Measure |
Estradiol
n=10 Participants
Participants are randomly assigned to treatment Sequence A: after achieving hormone suppression using Lupron, participants begin the addback period and take study medications for 8 weeks. During the 8 week period, participants will take placebo or estradiol or progesterone. Participants will not know when or for how long they are on active medication (i.e., estradiol or progesterone) or inactive (i.e., placebo) medication. When active medication is administered, participants randomized to treatment sequence A will receive estradiol addback first, followed by progesterone.
Estradiol and progesterone are never given simultaneously. Participants are on active medication for a total of 4 weeks.
Estradiol: During estradiol administration, 2mg of estradiol is given twice daily via oral capsule.
Micronized progesterone: During progesterone administration, 200mg of progesterone is given twice daily via oral capsule.
Leuprolide Acetate: Initial 3.75 mg intramuscular injection administered approximately Day 6 of menstrual cycle and then monthly thereafter for a total of 3 months.
Placebo Oral Capsule: Placebo is administered during the addback phase when participants are not taking active medication. Placebo is given so that medication administration occurs throughout the entire 8-week addback period in order to blind participants to when and for how long they are on the active medication.
|
Progesterone
Participants are randomly assigned to treatment Sequence B: after achieving hormone suppression using Lupron, participants begin the addback period and take study medications for 8 weeks. During the 8 week period, participants will take placebo or estradiol or progesterone. Participants will not know when or for how long they are on active medication (i.e., estradiol or progesterone) or inactive (i.e., placebo) medication. When active medication is administered, participants randomized to treatment sequence B will receive progesterone first followed by estradiol.
Estradiol and progesterone are never given simultaneously. Participants are on active medication for a total of 4 weeks.
Estradiol: During estradiol administration, 2mg of estradiol is given twice daily via oral capsule.
Micronized progesterone: During progesterone administration, 200mg of progesterone is given twice daily via oral capsule.
Leuprolide Acetate: Initial 3.75 mg intramuscular injection administered approximately Day 6 of menstrual cycle and then monthly thereafter for a total of 3 months.
Placebo Oral Capsule: Placebo is administered during the addback phase when participants are not taking active medication. Placebo is given so that medication administration occurs throughout the entire 8-week addback period in order to blind participants to when and for how long they are on the active medication.
|
|---|---|---|
|
Change in Self-Reported Reward Sensitivity Subscale Score During Estradiol Manipulation
|
-0.80 score on a scale
Standard Deviation 1.9
|
—
|
PRIMARY outcome
Timeframe: Baseline (Day 14 of baseline) to End of Intervention (Day 14 of intervention)Time (ms) between stimulus and response will be measured during the Monetary Incentive Delay (MID) task during the win trials during the estradiol intervention. During the MID task, participants need to select the correct response during "win" and "lose" conditions by pressing a button. Higher scores indicate a longer response time to the win trials. Change is defined by an average change score.
Outcome measures
| Measure |
Estradiol
n=10 Participants
Participants are randomly assigned to treatment Sequence A: after achieving hormone suppression using Lupron, participants begin the addback period and take study medications for 8 weeks. During the 8 week period, participants will take placebo or estradiol or progesterone. Participants will not know when or for how long they are on active medication (i.e., estradiol or progesterone) or inactive (i.e., placebo) medication. When active medication is administered, participants randomized to treatment sequence A will receive estradiol addback first, followed by progesterone.
Estradiol and progesterone are never given simultaneously. Participants are on active medication for a total of 4 weeks.
Estradiol: During estradiol administration, 2mg of estradiol is given twice daily via oral capsule.
Micronized progesterone: During progesterone administration, 200mg of progesterone is given twice daily via oral capsule.
Leuprolide Acetate: Initial 3.75 mg intramuscular injection administered approximately Day 6 of menstrual cycle and then monthly thereafter for a total of 3 months.
Placebo Oral Capsule: Placebo is administered during the addback phase when participants are not taking active medication. Placebo is given so that medication administration occurs throughout the entire 8-week addback period in order to blind participants to when and for how long they are on the active medication.
|
Progesterone
Participants are randomly assigned to treatment Sequence B: after achieving hormone suppression using Lupron, participants begin the addback period and take study medications for 8 weeks. During the 8 week period, participants will take placebo or estradiol or progesterone. Participants will not know when or for how long they are on active medication (i.e., estradiol or progesterone) or inactive (i.e., placebo) medication. When active medication is administered, participants randomized to treatment sequence B will receive progesterone first followed by estradiol.
Estradiol and progesterone are never given simultaneously. Participants are on active medication for a total of 4 weeks.
Estradiol: During estradiol administration, 2mg of estradiol is given twice daily via oral capsule.
Micronized progesterone: During progesterone administration, 200mg of progesterone is given twice daily via oral capsule.
Leuprolide Acetate: Initial 3.75 mg intramuscular injection administered approximately Day 6 of menstrual cycle and then monthly thereafter for a total of 3 months.
Placebo Oral Capsule: Placebo is administered during the addback phase when participants are not taking active medication. Placebo is given so that medication administration occurs throughout the entire 8-week addback period in order to blind participants to when and for how long they are on the active medication.
|
|---|---|---|
|
Change in Response Latency to Reward During the Monetary Incentive Delay Task During Estradiol Manipulation
|
-9.0 ms
Standard Deviation 44.0
|
—
|
PRIMARY outcome
Timeframe: Baseline (Day 14 of baseline) to End of Intervention (Day 14 of intervention)During the estradiol intervention, participants will be asked to make a series of hypothetical choices between small, sooner (impulsive) vs. larger, later (self controlled) hypothetical monetary outcomes. k is a hyperbolic function with larger k values indicating more valuation of a larger delayed reward and smaller values indicating preference for more immediate, smaller rewards (more impulsivity). Change is defined as the average change in k.
Outcome measures
| Measure |
Estradiol
n=10 Participants
Participants are randomly assigned to treatment Sequence A: after achieving hormone suppression using Lupron, participants begin the addback period and take study medications for 8 weeks. During the 8 week period, participants will take placebo or estradiol or progesterone. Participants will not know when or for how long they are on active medication (i.e., estradiol or progesterone) or inactive (i.e., placebo) medication. When active medication is administered, participants randomized to treatment sequence A will receive estradiol addback first, followed by progesterone.
Estradiol and progesterone are never given simultaneously. Participants are on active medication for a total of 4 weeks.
Estradiol: During estradiol administration, 2mg of estradiol is given twice daily via oral capsule.
Micronized progesterone: During progesterone administration, 200mg of progesterone is given twice daily via oral capsule.
Leuprolide Acetate: Initial 3.75 mg intramuscular injection administered approximately Day 6 of menstrual cycle and then monthly thereafter for a total of 3 months.
Placebo Oral Capsule: Placebo is administered during the addback phase when participants are not taking active medication. Placebo is given so that medication administration occurs throughout the entire 8-week addback period in order to blind participants to when and for how long they are on the active medication.
|
Progesterone
Participants are randomly assigned to treatment Sequence B: after achieving hormone suppression using Lupron, participants begin the addback period and take study medications for 8 weeks. During the 8 week period, participants will take placebo or estradiol or progesterone. Participants will not know when or for how long they are on active medication (i.e., estradiol or progesterone) or inactive (i.e., placebo) medication. When active medication is administered, participants randomized to treatment sequence B will receive progesterone first followed by estradiol.
Estradiol and progesterone are never given simultaneously. Participants are on active medication for a total of 4 weeks.
Estradiol: During estradiol administration, 2mg of estradiol is given twice daily via oral capsule.
Micronized progesterone: During progesterone administration, 200mg of progesterone is given twice daily via oral capsule.
Leuprolide Acetate: Initial 3.75 mg intramuscular injection administered approximately Day 6 of menstrual cycle and then monthly thereafter for a total of 3 months.
Placebo Oral Capsule: Placebo is administered during the addback phase when participants are not taking active medication. Placebo is given so that medication administration occurs throughout the entire 8-week addback period in order to blind participants to when and for how long they are on the active medication.
|
|---|---|---|
|
Change in Delay Discounting Parameter k Using the Monetary Choice Questionnaire With Estradiol Manipulation
|
-0.0047 k value
Standard Deviation 0.011
|
—
|
PRIMARY outcome
Timeframe: Baseline (Day 14 of baseline) to End of Intervention (Day 14 of intervention)This measures assesses individual disposition toward avoidance of activities during the estradiol intervention. The Behavioural Inhibition subscale of the Behavioural Inhibition Scale/Behavioral Activation Scale (BIS/BAS) assesses behavioural inhibition (BI) using participant self-reports. The minimum score on the BIS subscale is 7, maximum 28. Greater scores indicate greater behavioural inhibition. Change is defined by an average change score
Outcome measures
| Measure |
Estradiol
n=10 Participants
Participants are randomly assigned to treatment Sequence A: after achieving hormone suppression using Lupron, participants begin the addback period and take study medications for 8 weeks. During the 8 week period, participants will take placebo or estradiol or progesterone. Participants will not know when or for how long they are on active medication (i.e., estradiol or progesterone) or inactive (i.e., placebo) medication. When active medication is administered, participants randomized to treatment sequence A will receive estradiol addback first, followed by progesterone.
Estradiol and progesterone are never given simultaneously. Participants are on active medication for a total of 4 weeks.
Estradiol: During estradiol administration, 2mg of estradiol is given twice daily via oral capsule.
Micronized progesterone: During progesterone administration, 200mg of progesterone is given twice daily via oral capsule.
Leuprolide Acetate: Initial 3.75 mg intramuscular injection administered approximately Day 6 of menstrual cycle and then monthly thereafter for a total of 3 months.
Placebo Oral Capsule: Placebo is administered during the addback phase when participants are not taking active medication. Placebo is given so that medication administration occurs throughout the entire 8-week addback period in order to blind participants to when and for how long they are on the active medication.
|
Progesterone
Participants are randomly assigned to treatment Sequence B: after achieving hormone suppression using Lupron, participants begin the addback period and take study medications for 8 weeks. During the 8 week period, participants will take placebo or estradiol or progesterone. Participants will not know when or for how long they are on active medication (i.e., estradiol or progesterone) or inactive (i.e., placebo) medication. When active medication is administered, participants randomized to treatment sequence B will receive progesterone first followed by estradiol.
Estradiol and progesterone are never given simultaneously. Participants are on active medication for a total of 4 weeks.
Estradiol: During estradiol administration, 2mg of estradiol is given twice daily via oral capsule.
Micronized progesterone: During progesterone administration, 200mg of progesterone is given twice daily via oral capsule.
Leuprolide Acetate: Initial 3.75 mg intramuscular injection administered approximately Day 6 of menstrual cycle and then monthly thereafter for a total of 3 months.
Placebo Oral Capsule: Placebo is administered during the addback phase when participants are not taking active medication. Placebo is given so that medication administration occurs throughout the entire 8-week addback period in order to blind participants to when and for how long they are on the active medication.
|
|---|---|---|
|
Change in Self-Reported Behavioral Inhibition Score During Estradiol Manipulation
|
0.90 score on a scale
Standard Deviation 1.8
|
—
|
PRIMARY outcome
Timeframe: Baseline (Day 14 of baseline) to End of Intervention (Day 14 of intervention)This measures assesses individual disposition toward engaging in activities during the estradiol intervention. Two BIS/BAS behavioural activation (BA) subscales will be used. The BA subscales used are Fun Seeking and Drive. Each subscale is summed to get the respective subscale scores. The minimum score on BA Fun Seeking and BA Drive are minimum 4 and maximum 16. Higher scores indicate greater behavioral activation. Change is defined by an average change score.
Outcome measures
| Measure |
Estradiol
n=10 Participants
Participants are randomly assigned to treatment Sequence A: after achieving hormone suppression using Lupron, participants begin the addback period and take study medications for 8 weeks. During the 8 week period, participants will take placebo or estradiol or progesterone. Participants will not know when or for how long they are on active medication (i.e., estradiol or progesterone) or inactive (i.e., placebo) medication. When active medication is administered, participants randomized to treatment sequence A will receive estradiol addback first, followed by progesterone.
Estradiol and progesterone are never given simultaneously. Participants are on active medication for a total of 4 weeks.
Estradiol: During estradiol administration, 2mg of estradiol is given twice daily via oral capsule.
Micronized progesterone: During progesterone administration, 200mg of progesterone is given twice daily via oral capsule.
Leuprolide Acetate: Initial 3.75 mg intramuscular injection administered approximately Day 6 of menstrual cycle and then monthly thereafter for a total of 3 months.
Placebo Oral Capsule: Placebo is administered during the addback phase when participants are not taking active medication. Placebo is given so that medication administration occurs throughout the entire 8-week addback period in order to blind participants to when and for how long they are on the active medication.
|
Progesterone
Participants are randomly assigned to treatment Sequence B: after achieving hormone suppression using Lupron, participants begin the addback period and take study medications for 8 weeks. During the 8 week period, participants will take placebo or estradiol or progesterone. Participants will not know when or for how long they are on active medication (i.e., estradiol or progesterone) or inactive (i.e., placebo) medication. When active medication is administered, participants randomized to treatment sequence B will receive progesterone first followed by estradiol.
Estradiol and progesterone are never given simultaneously. Participants are on active medication for a total of 4 weeks.
Estradiol: During estradiol administration, 2mg of estradiol is given twice daily via oral capsule.
Micronized progesterone: During progesterone administration, 200mg of progesterone is given twice daily via oral capsule.
Leuprolide Acetate: Initial 3.75 mg intramuscular injection administered approximately Day 6 of menstrual cycle and then monthly thereafter for a total of 3 months.
Placebo Oral Capsule: Placebo is administered during the addback phase when participants are not taking active medication. Placebo is given so that medication administration occurs throughout the entire 8-week addback period in order to blind participants to when and for how long they are on the active medication.
|
|---|---|---|
|
Change in Behavioral Activation Score During Estradiol Manipulation
Fun Seeking
|
-0.10 score on a scale
Standard Deviation 0.88
|
—
|
|
Change in Behavioral Activation Score During Estradiol Manipulation
Drive
|
0 score on a scale
Standard Deviation 1.4
|
—
|
PRIMARY outcome
Timeframe: Baseline (Day 14 of baseline) to End of Intervention (Day 14 of intervention)This measures assesses individual disposition toward avoiding and engaging in activities during estradiol intervention. The BIS/BAS reward responsiveness subscale will be used. The minimum score on the BA Reward Responsiveness subscale is 5, maximum 20. Higher scores indicate greater reward responsiveness. Change is defined by an average change score.
Outcome measures
| Measure |
Estradiol
n=10 Participants
Participants are randomly assigned to treatment Sequence A: after achieving hormone suppression using Lupron, participants begin the addback period and take study medications for 8 weeks. During the 8 week period, participants will take placebo or estradiol or progesterone. Participants will not know when or for how long they are on active medication (i.e., estradiol or progesterone) or inactive (i.e., placebo) medication. When active medication is administered, participants randomized to treatment sequence A will receive estradiol addback first, followed by progesterone.
Estradiol and progesterone are never given simultaneously. Participants are on active medication for a total of 4 weeks.
Estradiol: During estradiol administration, 2mg of estradiol is given twice daily via oral capsule.
Micronized progesterone: During progesterone administration, 200mg of progesterone is given twice daily via oral capsule.
Leuprolide Acetate: Initial 3.75 mg intramuscular injection administered approximately Day 6 of menstrual cycle and then monthly thereafter for a total of 3 months.
Placebo Oral Capsule: Placebo is administered during the addback phase when participants are not taking active medication. Placebo is given so that medication administration occurs throughout the entire 8-week addback period in order to blind participants to when and for how long they are on the active medication.
|
Progesterone
Participants are randomly assigned to treatment Sequence B: after achieving hormone suppression using Lupron, participants begin the addback period and take study medications for 8 weeks. During the 8 week period, participants will take placebo or estradiol or progesterone. Participants will not know when or for how long they are on active medication (i.e., estradiol or progesterone) or inactive (i.e., placebo) medication. When active medication is administered, participants randomized to treatment sequence B will receive progesterone first followed by estradiol.
Estradiol and progesterone are never given simultaneously. Participants are on active medication for a total of 4 weeks.
Estradiol: During estradiol administration, 2mg of estradiol is given twice daily via oral capsule.
Micronized progesterone: During progesterone administration, 200mg of progesterone is given twice daily via oral capsule.
Leuprolide Acetate: Initial 3.75 mg intramuscular injection administered approximately Day 6 of menstrual cycle and then monthly thereafter for a total of 3 months.
Placebo Oral Capsule: Placebo is administered during the addback phase when participants are not taking active medication. Placebo is given so that medication administration occurs throughout the entire 8-week addback period in order to blind participants to when and for how long they are on the active medication.
|
|---|---|---|
|
Change in Behavioral Activation Reward Responsiveness With Estradiol Manipulation
|
0.10 score on a scale
Standard Deviation 1.2
|
—
|
PRIMARY outcome
Timeframe: Baseline (Day 14 of baseline) to End of Intervention (Day 14 of intervention)Population: Data unavailable as task was not completed by one participant.
Behavioral response inhibition will be examined during a go/no-go computerized task during the estradiol intervention. Inhibitory control is defined by the response accuracy of the go no/go trials. Percent of errors is calculated as the number of "go" responses on a "no/go" trial" divided by the total number of "no/go" trials." Fewer errors ("go" response on a "no/go" trial) indicates better inhibitory control. Change is defined by an average change score.
Outcome measures
| Measure |
Estradiol
n=9 Participants
Participants are randomly assigned to treatment Sequence A: after achieving hormone suppression using Lupron, participants begin the addback period and take study medications for 8 weeks. During the 8 week period, participants will take placebo or estradiol or progesterone. Participants will not know when or for how long they are on active medication (i.e., estradiol or progesterone) or inactive (i.e., placebo) medication. When active medication is administered, participants randomized to treatment sequence A will receive estradiol addback first, followed by progesterone.
Estradiol and progesterone are never given simultaneously. Participants are on active medication for a total of 4 weeks.
Estradiol: During estradiol administration, 2mg of estradiol is given twice daily via oral capsule.
Micronized progesterone: During progesterone administration, 200mg of progesterone is given twice daily via oral capsule.
Leuprolide Acetate: Initial 3.75 mg intramuscular injection administered approximately Day 6 of menstrual cycle and then monthly thereafter for a total of 3 months.
Placebo Oral Capsule: Placebo is administered during the addback phase when participants are not taking active medication. Placebo is given so that medication administration occurs throughout the entire 8-week addback period in order to blind participants to when and for how long they are on the active medication.
|
Progesterone
Participants are randomly assigned to treatment Sequence B: after achieving hormone suppression using Lupron, participants begin the addback period and take study medications for 8 weeks. During the 8 week period, participants will take placebo or estradiol or progesterone. Participants will not know when or for how long they are on active medication (i.e., estradiol or progesterone) or inactive (i.e., placebo) medication. When active medication is administered, participants randomized to treatment sequence B will receive progesterone first followed by estradiol.
Estradiol and progesterone are never given simultaneously. Participants are on active medication for a total of 4 weeks.
Estradiol: During estradiol administration, 2mg of estradiol is given twice daily via oral capsule.
Micronized progesterone: During progesterone administration, 200mg of progesterone is given twice daily via oral capsule.
Leuprolide Acetate: Initial 3.75 mg intramuscular injection administered approximately Day 6 of menstrual cycle and then monthly thereafter for a total of 3 months.
Placebo Oral Capsule: Placebo is administered during the addback phase when participants are not taking active medication. Placebo is given so that medication administration occurs throughout the entire 8-week addback period in order to blind participants to when and for how long they are on the active medication.
|
|---|---|---|
|
Change in Behavioral Inhibition During Estradiol Administration as Assessed Through a Behavioral Task
|
-0.094 percentage of errors
Standard Deviation 0.33
|
—
|
PRIMARY outcome
Timeframe: Baseline (Day 14 of baseline) to End of Intervention (Day 14 of intervention)Pearson correlations between change in self-reported reward response and change in binge eating between baseline and estradiol intervention will be examined. Binge eating is defined as the sum score from the Eating Pathology Symptom Inventory (EPSI). Self-reported reward response is defined as the BAS reward responsiveness subscale score and the Sensitivity to Reward/Sensitivity to Punishment Questionnaire (SPSRQ) sensitivity to reward subscale score. Change in binge eating and change in reward response between baseline and estradiol intervention was calculated and a correlation conducted between change scores.
Outcome measures
| Measure |
Estradiol
n=10 Participants
Participants are randomly assigned to treatment Sequence A: after achieving hormone suppression using Lupron, participants begin the addback period and take study medications for 8 weeks. During the 8 week period, participants will take placebo or estradiol or progesterone. Participants will not know when or for how long they are on active medication (i.e., estradiol or progesterone) or inactive (i.e., placebo) medication. When active medication is administered, participants randomized to treatment sequence A will receive estradiol addback first, followed by progesterone.
Estradiol and progesterone are never given simultaneously. Participants are on active medication for a total of 4 weeks.
Estradiol: During estradiol administration, 2mg of estradiol is given twice daily via oral capsule.
Micronized progesterone: During progesterone administration, 200mg of progesterone is given twice daily via oral capsule.
Leuprolide Acetate: Initial 3.75 mg intramuscular injection administered approximately Day 6 of menstrual cycle and then monthly thereafter for a total of 3 months.
Placebo Oral Capsule: Placebo is administered during the addback phase when participants are not taking active medication. Placebo is given so that medication administration occurs throughout the entire 8-week addback period in order to blind participants to when and for how long they are on the active medication.
|
Progesterone
Participants are randomly assigned to treatment Sequence B: after achieving hormone suppression using Lupron, participants begin the addback period and take study medications for 8 weeks. During the 8 week period, participants will take placebo or estradiol or progesterone. Participants will not know when or for how long they are on active medication (i.e., estradiol or progesterone) or inactive (i.e., placebo) medication. When active medication is administered, participants randomized to treatment sequence B will receive progesterone first followed by estradiol.
Estradiol and progesterone are never given simultaneously. Participants are on active medication for a total of 4 weeks.
Estradiol: During estradiol administration, 2mg of estradiol is given twice daily via oral capsule.
Micronized progesterone: During progesterone administration, 200mg of progesterone is given twice daily via oral capsule.
Leuprolide Acetate: Initial 3.75 mg intramuscular injection administered approximately Day 6 of menstrual cycle and then monthly thereafter for a total of 3 months.
Placebo Oral Capsule: Placebo is administered during the addback phase when participants are not taking active medication. Placebo is given so that medication administration occurs throughout the entire 8-week addback period in order to blind participants to when and for how long they are on the active medication.
|
|---|---|---|
|
Correlation Between Change in Reward Response and Change in Binge Eating Before and During Estradiol Manipulation
BAS Reward Responsiveness
|
-0.146 Pearson correlation coefficient
|
—
|
|
Correlation Between Change in Reward Response and Change in Binge Eating Before and During Estradiol Manipulation
Sensitivity to Reward
|
-0.132 Pearson correlation coefficient
|
—
|
Adverse Events
Estradiol
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Progesterone
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Lupron and Placebo
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Estradiol
n=10 participants at risk
Participants are randomly assigned to treatment Sequence A: after achieving hormone suppression using Lupron, participants begin the addback period and take study medications for 8 weeks. During the 8 week period, participants will take placebo or estradiol or progesterone. Participants will not know when or for how long they are on active medication (i.e., estradiol or progesterone) or inactive (i.e., placebo) medication. When active medication is administered, participants randomized to treatment sequence A will receive estradiol addback first, followed by progesterone.
Estradiol and progesterone are never given simultaneously. Participants are on active medication for a total of 4 weeks.
Estradiol: During estradiol administration, 2mg of estradiol is given twice daily via oral capsule.
Micronized progesterone: During progesterone administration, 200mg of progesterone is given twice daily via oral capsule.
Leuprolide Acetate: Initial 3.75 mg intramuscular injection administered approximately Day 6 of menstrual cycle and then monthly thereafter for a total of 3 months.
Placebo Oral Capsule: Placebo is administered during the addback phase when participants are not taking active medication. Placebo is given so that medication administration occurs throughout the entire 8-week addback period in order to blind participants to when and for how long they are on the active medication.
|
Progesterone
n=9 participants at risk
Participants are randomly assigned to treatment Sequence B: after achieving hormone suppression using Lupron, participants begin the addback period and take study medications for 8 weeks. During the 8 week period, participants will take placebo or estradiol or progesterone. Participants will not know when or for how long they are on active medication (i.e., estradiol or progesterone) or inactive (i.e., placebo) medication. When active medication is administered, participants randomized to treatment sequence B will receive progesterone first followed by estradiol.
Estradiol and progesterone are never given simultaneously. Participants are on active medication for a total of 4 weeks.
Estradiol: During estradiol administration, 2mg of estradiol is given twice daily via oral capsule.
Micronized progesterone: During progesterone administration, 200mg of progesterone is given twice daily via oral capsule.
Leuprolide Acetate: Initial 3.75 mg intramuscular injection administered approximately Day 6 of menstrual cycle and then monthly thereafter for a total of 3 months.
Placebo Oral Capsule: Placebo is administered during the addback phase when participants are not taking active medication. Placebo is given so that medication administration occurs throughout the entire 8-week addback period in order to blind participants to when and for how long they are on the active medication.
|
Lupron and Placebo
n=10 participants at risk
Prior to receiving hormone treatment, hormone suppression is achieved using Lupron and placebo.
Leuprolide Acetate: Initial 3.75 mg intramuscular injection administered approximately Day 6 of menstrual cycle and then monthly thereafter for a total of 3 months.
Placebo Oral Capsule: Placebo is administered during the addback phase when participants are not taking active medication. Placebo is given so that medication administration occurs throughout the entire 8-week addback period in order to blind participants to when and for how long they are on the active medication.
|
|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Localized rash at injection site
|
0.00%
0/10 • Adverse event data was tracked once participants' began receiving the Lupron and Placebo during the initial hormone suppression stage and continued through study completion (approximately 12 weeks).
All unresolved adverse events were tracked by the investigator until the events were resolved, the subject was lost to follow-up, or the adverse event was otherwise explained.
|
0.00%
0/9 • Adverse event data was tracked once participants' began receiving the Lupron and Placebo during the initial hormone suppression stage and continued through study completion (approximately 12 weeks).
All unresolved adverse events were tracked by the investigator until the events were resolved, the subject was lost to follow-up, or the adverse event was otherwise explained.
|
10.0%
1/10 • Number of events 1 • Adverse event data was tracked once participants' began receiving the Lupron and Placebo during the initial hormone suppression stage and continued through study completion (approximately 12 weeks).
All unresolved adverse events were tracked by the investigator until the events were resolved, the subject was lost to follow-up, or the adverse event was otherwise explained.
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/10 • Adverse event data was tracked once participants' began receiving the Lupron and Placebo during the initial hormone suppression stage and continued through study completion (approximately 12 weeks).
All unresolved adverse events were tracked by the investigator until the events were resolved, the subject was lost to follow-up, or the adverse event was otherwise explained.
|
0.00%
0/9 • Adverse event data was tracked once participants' began receiving the Lupron and Placebo during the initial hormone suppression stage and continued through study completion (approximately 12 weeks).
All unresolved adverse events were tracked by the investigator until the events were resolved, the subject was lost to follow-up, or the adverse event was otherwise explained.
|
10.0%
1/10 • Number of events 1 • Adverse event data was tracked once participants' began receiving the Lupron and Placebo during the initial hormone suppression stage and continued through study completion (approximately 12 weeks).
All unresolved adverse events were tracked by the investigator until the events were resolved, the subject was lost to follow-up, or the adverse event was otherwise explained.
|
|
Gastrointestinal disorders
Bloating
|
10.0%
1/10 • Number of events 1 • Adverse event data was tracked once participants' began receiving the Lupron and Placebo during the initial hormone suppression stage and continued through study completion (approximately 12 weeks).
All unresolved adverse events were tracked by the investigator until the events were resolved, the subject was lost to follow-up, or the adverse event was otherwise explained.
|
0.00%
0/9 • Adverse event data was tracked once participants' began receiving the Lupron and Placebo during the initial hormone suppression stage and continued through study completion (approximately 12 weeks).
All unresolved adverse events were tracked by the investigator until the events were resolved, the subject was lost to follow-up, or the adverse event was otherwise explained.
|
30.0%
3/10 • Number of events 3 • Adverse event data was tracked once participants' began receiving the Lupron and Placebo during the initial hormone suppression stage and continued through study completion (approximately 12 weeks).
All unresolved adverse events were tracked by the investigator until the events were resolved, the subject was lost to follow-up, or the adverse event was otherwise explained.
|
|
Nervous system disorders
Headache
|
0.00%
0/10 • Adverse event data was tracked once participants' began receiving the Lupron and Placebo during the initial hormone suppression stage and continued through study completion (approximately 12 weeks).
All unresolved adverse events were tracked by the investigator until the events were resolved, the subject was lost to follow-up, or the adverse event was otherwise explained.
|
11.1%
1/9 • Number of events 1 • Adverse event data was tracked once participants' began receiving the Lupron and Placebo during the initial hormone suppression stage and continued through study completion (approximately 12 weeks).
All unresolved adverse events were tracked by the investigator until the events were resolved, the subject was lost to follow-up, or the adverse event was otherwise explained.
|
40.0%
4/10 • Number of events 7 • Adverse event data was tracked once participants' began receiving the Lupron and Placebo during the initial hormone suppression stage and continued through study completion (approximately 12 weeks).
All unresolved adverse events were tracked by the investigator until the events were resolved, the subject was lost to follow-up, or the adverse event was otherwise explained.
|
|
Metabolism and nutrition disorders
Appetite increase
|
10.0%
1/10 • Number of events 1 • Adverse event data was tracked once participants' began receiving the Lupron and Placebo during the initial hormone suppression stage and continued through study completion (approximately 12 weeks).
All unresolved adverse events were tracked by the investigator until the events were resolved, the subject was lost to follow-up, or the adverse event was otherwise explained.
|
11.1%
1/9 • Number of events 1 • Adverse event data was tracked once participants' began receiving the Lupron and Placebo during the initial hormone suppression stage and continued through study completion (approximately 12 weeks).
All unresolved adverse events were tracked by the investigator until the events were resolved, the subject was lost to follow-up, or the adverse event was otherwise explained.
|
0.00%
0/10 • Adverse event data was tracked once participants' began receiving the Lupron and Placebo during the initial hormone suppression stage and continued through study completion (approximately 12 weeks).
All unresolved adverse events were tracked by the investigator until the events were resolved, the subject was lost to follow-up, or the adverse event was otherwise explained.
|
|
Musculoskeletal and connective tissue disorders
Joint discomfort
|
10.0%
1/10 • Number of events 1 • Adverse event data was tracked once participants' began receiving the Lupron and Placebo during the initial hormone suppression stage and continued through study completion (approximately 12 weeks).
All unresolved adverse events were tracked by the investigator until the events were resolved, the subject was lost to follow-up, or the adverse event was otherwise explained.
|
0.00%
0/9 • Adverse event data was tracked once participants' began receiving the Lupron and Placebo during the initial hormone suppression stage and continued through study completion (approximately 12 weeks).
All unresolved adverse events were tracked by the investigator until the events were resolved, the subject was lost to follow-up, or the adverse event was otherwise explained.
|
0.00%
0/10 • Adverse event data was tracked once participants' began receiving the Lupron and Placebo during the initial hormone suppression stage and continued through study completion (approximately 12 weeks).
All unresolved adverse events were tracked by the investigator until the events were resolved, the subject was lost to follow-up, or the adverse event was otherwise explained.
|
|
Reproductive system and breast disorders
Spotting
|
0.00%
0/10 • Adverse event data was tracked once participants' began receiving the Lupron and Placebo during the initial hormone suppression stage and continued through study completion (approximately 12 weeks).
All unresolved adverse events were tracked by the investigator until the events were resolved, the subject was lost to follow-up, or the adverse event was otherwise explained.
|
0.00%
0/9 • Adverse event data was tracked once participants' began receiving the Lupron and Placebo during the initial hormone suppression stage and continued through study completion (approximately 12 weeks).
All unresolved adverse events were tracked by the investigator until the events were resolved, the subject was lost to follow-up, or the adverse event was otherwise explained.
|
50.0%
5/10 • Number of events 8 • Adverse event data was tracked once participants' began receiving the Lupron and Placebo during the initial hormone suppression stage and continued through study completion (approximately 12 weeks).
All unresolved adverse events were tracked by the investigator until the events were resolved, the subject was lost to follow-up, or the adverse event was otherwise explained.
|
|
Reproductive system and breast disorders
Abdominal Cramps
|
10.0%
1/10 • Number of events 1 • Adverse event data was tracked once participants' began receiving the Lupron and Placebo during the initial hormone suppression stage and continued through study completion (approximately 12 weeks).
All unresolved adverse events were tracked by the investigator until the events were resolved, the subject was lost to follow-up, or the adverse event was otherwise explained.
|
0.00%
0/9 • Adverse event data was tracked once participants' began receiving the Lupron and Placebo during the initial hormone suppression stage and continued through study completion (approximately 12 weeks).
All unresolved adverse events were tracked by the investigator until the events were resolved, the subject was lost to follow-up, or the adverse event was otherwise explained.
|
20.0%
2/10 • Number of events 5 • Adverse event data was tracked once participants' began receiving the Lupron and Placebo during the initial hormone suppression stage and continued through study completion (approximately 12 weeks).
All unresolved adverse events were tracked by the investigator until the events were resolved, the subject was lost to follow-up, or the adverse event was otherwise explained.
|
|
Nervous system disorders
Memory Impairment
|
0.00%
0/10 • Adverse event data was tracked once participants' began receiving the Lupron and Placebo during the initial hormone suppression stage and continued through study completion (approximately 12 weeks).
All unresolved adverse events were tracked by the investigator until the events were resolved, the subject was lost to follow-up, or the adverse event was otherwise explained.
|
0.00%
0/9 • Adverse event data was tracked once participants' began receiving the Lupron and Placebo during the initial hormone suppression stage and continued through study completion (approximately 12 weeks).
All unresolved adverse events were tracked by the investigator until the events were resolved, the subject was lost to follow-up, or the adverse event was otherwise explained.
|
10.0%
1/10 • Number of events 1 • Adverse event data was tracked once participants' began receiving the Lupron and Placebo during the initial hormone suppression stage and continued through study completion (approximately 12 weeks).
All unresolved adverse events were tracked by the investigator until the events were resolved, the subject was lost to follow-up, or the adverse event was otherwise explained.
|
|
Endocrine disorders
Hot Flashes
|
30.0%
3/10 • Number of events 18 • Adverse event data was tracked once participants' began receiving the Lupron and Placebo during the initial hormone suppression stage and continued through study completion (approximately 12 weeks).
All unresolved adverse events were tracked by the investigator until the events were resolved, the subject was lost to follow-up, or the adverse event was otherwise explained.
|
44.4%
4/9 • Number of events 10 • Adverse event data was tracked once participants' began receiving the Lupron and Placebo during the initial hormone suppression stage and continued through study completion (approximately 12 weeks).
All unresolved adverse events were tracked by the investigator until the events were resolved, the subject was lost to follow-up, or the adverse event was otherwise explained.
|
60.0%
6/10 • Number of events 54 • Adverse event data was tracked once participants' began receiving the Lupron and Placebo during the initial hormone suppression stage and continued through study completion (approximately 12 weeks).
All unresolved adverse events were tracked by the investigator until the events were resolved, the subject was lost to follow-up, or the adverse event was otherwise explained.
|
|
General disorders
Fatigue
|
10.0%
1/10 • Number of events 1 • Adverse event data was tracked once participants' began receiving the Lupron and Placebo during the initial hormone suppression stage and continued through study completion (approximately 12 weeks).
All unresolved adverse events were tracked by the investigator until the events were resolved, the subject was lost to follow-up, or the adverse event was otherwise explained.
|
11.1%
1/9 • Number of events 1 • Adverse event data was tracked once participants' began receiving the Lupron and Placebo during the initial hormone suppression stage and continued through study completion (approximately 12 weeks).
All unresolved adverse events were tracked by the investigator until the events were resolved, the subject was lost to follow-up, or the adverse event was otherwise explained.
|
10.0%
1/10 • Number of events 1 • Adverse event data was tracked once participants' began receiving the Lupron and Placebo during the initial hormone suppression stage and continued through study completion (approximately 12 weeks).
All unresolved adverse events were tracked by the investigator until the events were resolved, the subject was lost to follow-up, or the adverse event was otherwise explained.
|
|
General disorders
Decreased Energy Level
|
10.0%
1/10 • Number of events 1 • Adverse event data was tracked once participants' began receiving the Lupron and Placebo during the initial hormone suppression stage and continued through study completion (approximately 12 weeks).
All unresolved adverse events were tracked by the investigator until the events were resolved, the subject was lost to follow-up, or the adverse event was otherwise explained.
|
0.00%
0/9 • Adverse event data was tracked once participants' began receiving the Lupron and Placebo during the initial hormone suppression stage and continued through study completion (approximately 12 weeks).
All unresolved adverse events were tracked by the investigator until the events were resolved, the subject was lost to follow-up, or the adverse event was otherwise explained.
|
0.00%
0/10 • Adverse event data was tracked once participants' began receiving the Lupron and Placebo during the initial hormone suppression stage and continued through study completion (approximately 12 weeks).
All unresolved adverse events were tracked by the investigator until the events were resolved, the subject was lost to follow-up, or the adverse event was otherwise explained.
|
|
Reproductive system and breast disorders
Breast Tenderness
|
0.00%
0/10 • Adverse event data was tracked once participants' began receiving the Lupron and Placebo during the initial hormone suppression stage and continued through study completion (approximately 12 weeks).
All unresolved adverse events were tracked by the investigator until the events were resolved, the subject was lost to follow-up, or the adverse event was otherwise explained.
|
0.00%
0/9 • Adverse event data was tracked once participants' began receiving the Lupron and Placebo during the initial hormone suppression stage and continued through study completion (approximately 12 weeks).
All unresolved adverse events were tracked by the investigator until the events were resolved, the subject was lost to follow-up, or the adverse event was otherwise explained.
|
20.0%
2/10 • Number of events 2 • Adverse event data was tracked once participants' began receiving the Lupron and Placebo during the initial hormone suppression stage and continued through study completion (approximately 12 weeks).
All unresolved adverse events were tracked by the investigator until the events were resolved, the subject was lost to follow-up, or the adverse event was otherwise explained.
|
|
General disorders
Insomnia
|
0.00%
0/10 • Adverse event data was tracked once participants' began receiving the Lupron and Placebo during the initial hormone suppression stage and continued through study completion (approximately 12 weeks).
All unresolved adverse events were tracked by the investigator until the events were resolved, the subject was lost to follow-up, or the adverse event was otherwise explained.
|
0.00%
0/9 • Adverse event data was tracked once participants' began receiving the Lupron and Placebo during the initial hormone suppression stage and continued through study completion (approximately 12 weeks).
All unresolved adverse events were tracked by the investigator until the events were resolved, the subject was lost to follow-up, or the adverse event was otherwise explained.
|
10.0%
1/10 • Number of events 3 • Adverse event data was tracked once participants' began receiving the Lupron and Placebo during the initial hormone suppression stage and continued through study completion (approximately 12 weeks).
All unresolved adverse events were tracked by the investigator until the events were resolved, the subject was lost to follow-up, or the adverse event was otherwise explained.
|
|
Psychiatric disorders
Lethargic
|
0.00%
0/10 • Adverse event data was tracked once participants' began receiving the Lupron and Placebo during the initial hormone suppression stage and continued through study completion (approximately 12 weeks).
All unresolved adverse events were tracked by the investigator until the events were resolved, the subject was lost to follow-up, or the adverse event was otherwise explained.
|
0.00%
0/9 • Adverse event data was tracked once participants' began receiving the Lupron and Placebo during the initial hormone suppression stage and continued through study completion (approximately 12 weeks).
All unresolved adverse events were tracked by the investigator until the events were resolved, the subject was lost to follow-up, or the adverse event was otherwise explained.
|
10.0%
1/10 • Number of events 1 • Adverse event data was tracked once participants' began receiving the Lupron and Placebo during the initial hormone suppression stage and continued through study completion (approximately 12 weeks).
All unresolved adverse events were tracked by the investigator until the events were resolved, the subject was lost to follow-up, or the adverse event was otherwise explained.
|
|
General disorders
Drowsiness
|
0.00%
0/10 • Adverse event data was tracked once participants' began receiving the Lupron and Placebo during the initial hormone suppression stage and continued through study completion (approximately 12 weeks).
All unresolved adverse events were tracked by the investigator until the events were resolved, the subject was lost to follow-up, or the adverse event was otherwise explained.
|
22.2%
2/9 • Number of events 2 • Adverse event data was tracked once participants' began receiving the Lupron and Placebo during the initial hormone suppression stage and continued through study completion (approximately 12 weeks).
All unresolved adverse events were tracked by the investigator until the events were resolved, the subject was lost to follow-up, or the adverse event was otherwise explained.
|
0.00%
0/10 • Adverse event data was tracked once participants' began receiving the Lupron and Placebo during the initial hormone suppression stage and continued through study completion (approximately 12 weeks).
All unresolved adverse events were tracked by the investigator until the events were resolved, the subject was lost to follow-up, or the adverse event was otherwise explained.
|
|
Reproductive system and breast disorders
Menstrual Bleeding
|
0.00%
0/10 • Adverse event data was tracked once participants' began receiving the Lupron and Placebo during the initial hormone suppression stage and continued through study completion (approximately 12 weeks).
All unresolved adverse events were tracked by the investigator until the events were resolved, the subject was lost to follow-up, or the adverse event was otherwise explained.
|
0.00%
0/9 • Adverse event data was tracked once participants' began receiving the Lupron and Placebo during the initial hormone suppression stage and continued through study completion (approximately 12 weeks).
All unresolved adverse events were tracked by the investigator until the events were resolved, the subject was lost to follow-up, or the adverse event was otherwise explained.
|
10.0%
1/10 • Number of events 1 • Adverse event data was tracked once participants' began receiving the Lupron and Placebo during the initial hormone suppression stage and continued through study completion (approximately 12 weeks).
All unresolved adverse events were tracked by the investigator until the events were resolved, the subject was lost to follow-up, or the adverse event was otherwise explained.
|
|
General disorders
Feeling Hot
|
0.00%
0/10 • Adverse event data was tracked once participants' began receiving the Lupron and Placebo during the initial hormone suppression stage and continued through study completion (approximately 12 weeks).
All unresolved adverse events were tracked by the investigator until the events were resolved, the subject was lost to follow-up, or the adverse event was otherwise explained.
|
0.00%
0/9 • Adverse event data was tracked once participants' began receiving the Lupron and Placebo during the initial hormone suppression stage and continued through study completion (approximately 12 weeks).
All unresolved adverse events were tracked by the investigator until the events were resolved, the subject was lost to follow-up, or the adverse event was otherwise explained.
|
10.0%
1/10 • Number of events 1 • Adverse event data was tracked once participants' began receiving the Lupron and Placebo during the initial hormone suppression stage and continued through study completion (approximately 12 weeks).
All unresolved adverse events were tracked by the investigator until the events were resolved, the subject was lost to follow-up, or the adverse event was otherwise explained.
|
|
General disorders
Temperature Dysregulation
|
0.00%
0/10 • Adverse event data was tracked once participants' began receiving the Lupron and Placebo during the initial hormone suppression stage and continued through study completion (approximately 12 weeks).
All unresolved adverse events were tracked by the investigator until the events were resolved, the subject was lost to follow-up, or the adverse event was otherwise explained.
|
11.1%
1/9 • Number of events 1 • Adverse event data was tracked once participants' began receiving the Lupron and Placebo during the initial hormone suppression stage and continued through study completion (approximately 12 weeks).
All unresolved adverse events were tracked by the investigator until the events were resolved, the subject was lost to follow-up, or the adverse event was otherwise explained.
|
0.00%
0/10 • Adverse event data was tracked once participants' began receiving the Lupron and Placebo during the initial hormone suppression stage and continued through study completion (approximately 12 weeks).
All unresolved adverse events were tracked by the investigator until the events were resolved, the subject was lost to follow-up, or the adverse event was otherwise explained.
|
Additional Information
Jessica Baker, PhD
University of North Carolina at Chapel Hill
Phone: 984-235-0858
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place