Trial Outcomes & Findings for Using Soy Estrogens to Prevent Bone Loss and Other Menopausal Symptoms (NCT NCT00076050)

NCT ID: NCT00076050

Last Updated: 2016-12-06

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 248 participants
• Primary outcome timeframe: baseline and 2 years
• Results posted on: 2016-12-06

Participant Flow

Participant milestones

Measure	Soy Isoflavone Group A total of 122 participants were randomized to receive a 200-mg dose of soy isoflavones in tablet form daily by mouth, over 2 years. The medication was delivered in four tablets that had to be taken fasting in the morning.	Placebo Group A total of 126 participants were randomized to receive placebo tablets by mouth daily over 2 years.The medication was delivered in four tablets that had to be taken fasting in the morning.
Overall Study STARTED	122	126
Overall Study COMPLETED	99	83
Overall Study NOT COMPLETED	23	43

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Using Soy Estrogens to Prevent Bone Loss and Other Menopausal Symptoms

Baseline characteristics by cohort

Measure	Soy Isoflavone Group n=122 Participants A total of 122 participants were randomized to receive a 200-mg dose of soy isoflavones in tablet form daily by mouth, over 2 years. The medication was delivered in four tablets that had to be taken fasting in the morning.	Placebo Group n=126 Participants A total of 126 participants were randomized to receive placebo tablets by mouth daily over 2 years.The medication was delivered in four tablets that had to be taken fasting in the morning.	Total n=248 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	122 Participants n=5 Participants	126 Participants n=7 Participants	248 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	53 years STANDARD_DEVIATION 3.3 • n=5 Participants	52 years STANDARD_DEVIATION 3.3 • n=7 Participants	52.5 years STANDARD_DEVIATION 3.3 • n=5 Participants
Sex: Female, Male Female	122 Participants n=5 Participants	126 Participants n=7 Participants	248 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	122 participants n=5 Participants	126 participants n=7 Participants	248 participants n=5 Participants

PRIMARY outcome

Timeframe: baseline and 2 years

Outcome measures

Measure	Soy Isoflavone Group n=99 Participants A total of 122 participants were randomized to receive a 200-mg dose of soy isoflavones in tablet form daily by mouth, over 2 years. The medication was delivered in four tablets that had to be taken fasting in the morning.	Placebo Group n=83 Participants A total of 126 participants were randomized to receive placebo tablets by mouth daily over 2 years.The medication was delivered in four tablets that had to be taken fasting in the morning.
Change From Baseline in Bone Mineral Density	1.146 g/cm2 Standard Deviation 0.125	1.132 g/cm2 Standard Deviation 0.124

SECONDARY outcome

Timeframe: baseline and 2 years

This self-administered questionnaire contains 23 items, distributed among 6 factors: anxiety and depressed mood (7 items), well-being (4 items), somatic symptoms (5 items), memory and concentration (3 items), vasomotor symptoms (2 items) and sleep problems (2 items). The instrument has a structured format and the response choices consist of 4-point Likert scales ('yes definitely' to 'no, not at all'). Item scores are collapsed into a dichotomous scale, where higher scores indicate a greater level of symptomatology or difficulty; i.e., if the response is 1 or 2 (positive response), the score = 1; if the response is 3 or 4 (negative response), the score is 0. Results can be reported as a total score, where the range is 0-23, but also for each dimension. Thus, the ranges of the subscales are: for anxiety and mood 0-7, for well-being 0-4, somatic symptoms 0-5, memory and concentration 0-3, vasomotor symptoms 0-2 and sleep problems 0-2.

Outcome measures

Measure	Soy Isoflavone Group n=99 Participants A total of 122 participants were randomized to receive a 200-mg dose of soy isoflavones in tablet form daily by mouth, over 2 years. The medication was delivered in four tablets that had to be taken fasting in the morning.	Placebo Group n=83 Participants A total of 126 participants were randomized to receive placebo tablets by mouth daily over 2 years.The medication was delivered in four tablets that had to be taken fasting in the morning.
Changes in Women's Health Questionnaire Score	-0.73 change in score Standard Error 0.54	-0.34 change in score Standard Error 0.77

SECONDARY outcome

Timeframe: baseline and 2 years

The Vaginal Maturation Value (VMV) describes the proportion of the three vaginal epithelial cell types (parabasal, intermediate and superficial) obtained from a swab of the vaginal walls. The changes in the proportion of each type of cells reflects the degree of exposure to estrogen of the vaginal epithelium. The VMV lists the percentage of each type of cell appearing on the smear, with the total of all three values equaling 100%. The index is read from left to right; i.e. VMI of 5/40/55 represents 5% parabasal cells, 40% intermediate cells and 55% superficial cells. Exposure to estrogens results in some parabasal cells, a greater proportion of intermediate cells and few superficial cells.

Outcome measures

Measure	Soy Isoflavone Group n=99 Participants A total of 122 participants were randomized to receive a 200-mg dose of soy isoflavones in tablet form daily by mouth, over 2 years. The medication was delivered in four tablets that had to be taken fasting in the morning.	Placebo Group n=83 Participants A total of 126 participants were randomized to receive placebo tablets by mouth daily over 2 years.The medication was delivered in four tablets that had to be taken fasting in the morning.
Change in Vaginal Maturation Value	0.20 score Standard Error 2.53	-1.78 score Standard Error 2.86

Adverse Events

Soy Isoflavones

Serious events: 9 serious events

Other events: 121 other events

Deaths: 0 deaths

Placebo

Serious events: 3 serious events

Other events: 122 other events

Deaths: 0 deaths

Serious adverse events

Measure	Soy Isoflavones n=122 participants at risk A total of 122 participants were randomized to receive a 200-mg dose of soy isoflavones in tablet form daily by mouth, over 2 years. The medication was delivered in four tablets that had to be taken fasting in the morning.	Placebo n=126 participants at risk A total of 126 participants were randomized to receive placebo tablets by mouth daily over 2 years.The medication was delivered in four tablets that had to be taken fasting in the morning.
Musculoskeletal and connective tissue disorders fracture	5.7% 7/122 • Number of events 7	0.79% 1/126 • Number of events 1
Reproductive system and breast disorders breast cancer	0.82% 1/122 • Number of events 1	0.79% 1/126 • Number of events 1
Blood and lymphatic system disorders leukemia	0.82% 1/122 • Number of events 1	0.79% 1/126 • Number of events 1

Other adverse events

Measure	Soy Isoflavones n=122 participants at risk A total of 122 participants were randomized to receive a 200-mg dose of soy isoflavones in tablet form daily by mouth, over 2 years. The medication was delivered in four tablets that had to be taken fasting in the morning.	Placebo n=126 participants at risk A total of 126 participants were randomized to receive placebo tablets by mouth daily over 2 years.The medication was delivered in four tablets that had to be taken fasting in the morning.
Gastrointestinal disorders abdominal bloating	52.5% 64/122	42.9% 54/126
Nervous system disorders headache	44.3% 54/122	34.1% 43/126
Skin and subcutaneous tissue disorders hair loss	32.0% 39/122	34.1% 43/126
Gastrointestinal disorders dry mouth	28.7% 35/122	29.4% 37/126
Gastrointestinal disorders constipation	31.1% 38/122	20.6% 26/126
Reproductive system and breast disorders breast tenderness	25.4% 31/122	23.8% 30/126
Skin and subcutaneous tissue disorders edema of lower exteremity	15.6% 19/122	15.1% 19/126
Reproductive system and breast disorders vaginal bleeding	13.9% 17/122	14.3% 18/126
Gastrointestinal disorders anorexia	17.2% 21/122	9.5% 12/126
Reproductive system and breast disorders abnormal mammogram	7.4% 9/122	4.8% 6/126
Musculoskeletal and connective tissue disorders joint tenderness	4.9% 6/122	5.6% 7/126
Musculoskeletal and connective tissue disorders tenderness lower extremities	2.5% 3/122	7.1% 9/126
Respiratory, thoracic and mediastinal disorders upper respiratory track infection	5.7% 7/122	4.0% 5/126
Renal and urinary disorders urinary track infection	5.7% 7/122	4.0% 5/126
Cardiac disorders hypertension	4.1% 5/122	4.0% 5/126

Additional Information

Silvina Levis MD

University of Miami

Phone: 305-575-3388

Email: slevis@med.miami.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place