Trial Outcomes & Findings for Research Investigation of Soy and Estrogen (NCT NCT00997893)
NCT ID: NCT00997893
Last Updated: 2020-12-07
Results Overview
STAI-6; State-Trait Anxiety Inventory- Short Form is a measure of anxiety where higher scores indicate higher/elevated anxiety. Minimum value 6 is and maximum value is 24.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
96 participants
Primary outcome timeframe
Week 0, 10, 12, and 16-18
Results posted on
2020-12-07
Participant Flow
A total of 63 of the 96 enrolled subjects met the post-enrollment eligibility criteria. Twenty-three of 63 enrolled subjects withdrew prior to randomization. A total of 40 subjects were randomized.
Participant milestones
| Measure |
Estradiol/Medroxyprogesterone Acetate
1 mg/d oral Estradiol pill and 0 mg/d oral placebo pill for 12 weeks, followed by 10 mg/d oral medroxyprogesterone acetate (MPA) pill, for 10 days.
|
Soy Phytoestrogen
55 mg/twice daily oral Novasoy®/Soy Phytoestrogen pill for 12 weeks, followed by 0 mg/d oral placebo pill, for 10 days.
|
Placebo
0 mg tablet/twice daily oral placebo pill for 12 weeks, followed by 0 mg/d oral placebo pill, for 10 days.
|
|---|---|---|---|
|
Overall Study
STARTED
|
14
|
13
|
13
|
|
Overall Study
COMPLETED
|
12
|
12
|
13
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
0
|
Reasons for withdrawal
| Measure |
Estradiol/Medroxyprogesterone Acetate
1 mg/d oral Estradiol pill and 0 mg/d oral placebo pill for 12 weeks, followed by 10 mg/d oral medroxyprogesterone acetate (MPA) pill, for 10 days.
|
Soy Phytoestrogen
55 mg/twice daily oral Novasoy®/Soy Phytoestrogen pill for 12 weeks, followed by 0 mg/d oral placebo pill, for 10 days.
|
Placebo
0 mg tablet/twice daily oral placebo pill for 12 weeks, followed by 0 mg/d oral placebo pill, for 10 days.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
0
|
|
Overall Study
Unable to meet study timelines
|
1
|
0
|
0
|
|
Overall Study
Pain/pain meds during Visit 4
|
0
|
1
|
0
|
Baseline Characteristics
Research Investigation of Soy and Estrogen
Baseline characteristics by cohort
| Measure |
Estradiol/Medroxyprogesterone Acetate
n=14 Participants
1 mg oral estradiol for 12 weeks followed by 10 mg/d oral MPA
|
Phytoestrogen
n=13 Participants
55 mg Novasoy pill b.i.d. (Total daily dose 110 mg)
|
Placebo
n=13 Participants
Placebo pill b.i.d. (0 mg Novasoy® and 0 mg estradiol)
|
Total
n=40 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
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
14 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
40 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Continuous
|
50.07 years
STANDARD_DEVIATION 4.16 • n=5 Participants
|
51.38 years
STANDARD_DEVIATION 3.90 • n=7 Participants
|
49.31 years
STANDARD_DEVIATION 3.84 • n=5 Participants
|
50.25 years
STANDARD_DEVIATION 3.97 • n=4 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
40 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
14 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
40 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Week 0, 10, 12, and 16-18STAI-6; State-Trait Anxiety Inventory- Short Form is a measure of anxiety where higher scores indicate higher/elevated anxiety. Minimum value 6 is and maximum value is 24.
Outcome measures
| Measure |
Estradiol/Medroxyprogesterone Acetate
n=14 Participants
1 mg oral estradiol for 12 weeks followed by 10 mg/d oral MPA
|
Phytoestrogen
n=13 Participants
55 mg Novasoy pill b.i.d.
|
Placebo
n=13 Participants
Placebo pill b.i.d
|
|---|---|---|---|
|
Change in STAI-6 Score
Baseline (Week 0)
|
12.31 score on STAI scale
Standard Error 0.74
|
11.85 score on STAI scale
Standard Error 0.74
|
10.76 score on STAI scale
Standard Error 0.76
|
|
Change in STAI-6 Score
Early-Treatment(Week 10)
|
11.69 score on STAI scale
Standard Error 0.73
|
11.38 score on STAI scale
Standard Error 0.71
|
11.24 score on STAI scale
Standard Error 0.74
|
|
Change in STAI-6 Score
Late-Treatment(Week 12)
|
12.88 score on STAI scale
Standard Error 0.75
|
10.99 score on STAI scale
Standard Error 0.72
|
10.55 score on STAI scale
Standard Error 0.75
|
|
Change in STAI-6 Score
Post-Treatment (Week 16-18)
|
11.84 score on STAI scale
Standard Error 0.74
|
11.19 score on STAI scale
Standard Error 0.72
|
11.15 score on STAI scale
Standard Error 0.76
|
PRIMARY outcome
Timeframe: Baseline (Week 0) and Treatment (Week 12)STAI-6; State-Trait Anxiety Inventory- Short Form is a measure of anxiety where higher scores indicate higher/elevated anxiety. Minimum value 6 is and maximum value is 24.
Outcome measures
| Measure |
Estradiol/Medroxyprogesterone Acetate
n=14 Participants
1 mg oral estradiol for 12 weeks followed by 10 mg/d oral MPA
|
Phytoestrogen
n=13 Participants
55 mg Novasoy pill b.i.d.
|
Placebo
n=13 Participants
Placebo pill b.i.d
|
|---|---|---|---|
|
Changes in STAI-6 Scores Before and After Psychosocial Stressor Over Time
Baseline (Week 0), Before Stressor
|
8.73 score on STAI scale
Standard Error 0.89
|
8.69 score on STAI scale
Standard Error 0.89
|
9.77 score on STAI scale
Standard Error 0.89
|
|
Changes in STAI-6 Scores Before and After Psychosocial Stressor Over Time
Baseline (Week 0), After Stressor
|
12.61 score on STAI scale
Standard Error 0.89
|
12.92 score on STAI scale
Standard Error 0.89
|
12.23 score on STAI scale
Standard Error 0.89
|
|
Changes in STAI-6 Scores Before and After Psychosocial Stressor Over Time
Post-Treatment (Week 12), Before Stressor
|
8.25 score on STAI scale
Standard Error 0.94
|
10.87 score on STAI scale
Standard Error 0.91
|
9.61 score on STAI scale
Standard Error 0.89
|
|
Changes in STAI-6 Scores Before and After Psychosocial Stressor Over Time
Post-Treatment (Week 12), After Stressor
|
13.70 score on STAI scale
Standard Error 0.94
|
15.37 score on STAI scale
Standard Error 0.91
|
12.69 score on STAI scale
Standard Error 0.89
|
PRIMARY outcome
Timeframe: Baseline (Week 0) and Treatment (Week 12)Proportion correct out of 18 word pairs (6 positive, 6 negative and 6 neutral) after laboratory-induced stress using Trier Social Stress Test (TSST). Maximum score is 18 and minimum score is 0; higher scores indicate a better score.
Outcome measures
| Measure |
Estradiol/Medroxyprogesterone Acetate
n=14 Participants
1 mg oral estradiol for 12 weeks followed by 10 mg/d oral MPA
|
Phytoestrogen
n=13 Participants
55 mg Novasoy pill b.i.d.
|
Placebo
n=13 Participants
Placebo pill b.i.d
|
|---|---|---|---|
|
Memory for Emotionally Valent Words and Neutral Words
Baseline (Week 0)- Control
|
0.45 Proportion Correct
Standard Error 0.08
|
0.45 Proportion Correct
Standard Error 0.08
|
0.38 Proportion Correct
Standard Error 0.08
|
|
Memory for Emotionally Valent Words and Neutral Words
Baseline (Week 0)- TSST
|
0.48 Proportion Correct
Standard Error 0.08
|
0.40 Proportion Correct
Standard Error 0.08
|
0.47 Proportion Correct
Standard Error 0.08
|
|
Memory for Emotionally Valent Words and Neutral Words
Post-Treatment (Week 12)- Control
|
0.47 Proportion Correct
Standard Error 0.08
|
0.42 Proportion Correct
Standard Error 0.08
|
0.37 Proportion Correct
Standard Error 0.08
|
|
Memory for Emotionally Valent Words and Neutral Words
Post-Treatment (Week 12)-TSST
|
0.51 Proportion Correct
Standard Error 0.08
|
0.46 Proportion Correct
Standard Error 0.08
|
0.44 Proportion Correct
Standard Error 0.08
|
PRIMARY outcome
Timeframe: Baseline and 12 weeksImmediate recall on the Logical Memory subset of the Wechsler Memory Scale-Revised, in which higher scores indicate a better recall and outcome. The minimum value is 0 and maximum value is 25.
Outcome measures
| Measure |
Estradiol/Medroxyprogesterone Acetate
n=14 Participants
1 mg oral estradiol for 12 weeks followed by 10 mg/d oral MPA
|
Phytoestrogen
n=13 Participants
55 mg Novasoy pill b.i.d.
|
Placebo
n=13 Participants
Placebo pill b.i.d
|
|---|---|---|---|
|
Change in Verbal Memory, Immediate Recall
|
-.02 test scores on the Logical Memory test
Standard Error 0.87
|
2.31 test scores on the Logical Memory test
Standard Error 0.82
|
2.08 test scores on the Logical Memory test
Standard Error 0.82
|
PRIMARY outcome
Timeframe: Baseline and 12 weeksDelayed recall on the Logical Memory subset of the Wechsler Memory Scale-Revised, in which higher scores indicate a better recall and outcome. The minimum value is 0 and maximum value is 25.
Outcome measures
| Measure |
Estradiol/Medroxyprogesterone Acetate
n=14 Participants
1 mg oral estradiol for 12 weeks followed by 10 mg/d oral MPA
|
Phytoestrogen
n=13 Participants
55 mg Novasoy pill b.i.d.
|
Placebo
n=13 Participants
Placebo pill b.i.d
|
|---|---|---|---|
|
Change in Verbal Memory, Delayed Recall
|
.87 Test scores on the Logical Memory test
Standard Error 1.03
|
1.61 Test scores on the Logical Memory test
Standard Error 0.96
|
1.08 Test scores on the Logical Memory test
Standard Error 0.96
|
Adverse Events
Estradiol/Medroxyprogesterone Acetate
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Phytoestrogen
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Estradiol/Medroxyprogesterone Acetate
n=14 participants at risk
1 mg oral estradiol for 12 weeks followed by 10 mg/d oral MPA
|
Phytoestrogen
n=13 participants at risk
55 mg Novasoy pill b.i.d.
|
Placebo
n=13 participants at risk
Placebo pill b.i.d
|
|---|---|---|---|
|
Reproductive system and breast disorders
Non-serious; irregular uterine bleeding
|
7.1%
1/14 • Number of events 1 • Adverse event reporting forms have been completed for all participants reporting adverse events during bi-weekly phone safety screenings (Week 2, 4, 6 and 8), as well as in person visits during Week 10, and Week 12.
|
0.00%
0/13 • Adverse event reporting forms have been completed for all participants reporting adverse events during bi-weekly phone safety screenings (Week 2, 4, 6 and 8), as well as in person visits during Week 10, and Week 12.
|
0.00%
0/13 • Adverse event reporting forms have been completed for all participants reporting adverse events during bi-weekly phone safety screenings (Week 2, 4, 6 and 8), as well as in person visits during Week 10, and Week 12.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place