Trial Outcomes & Findings for Soy Protein and Breast Cancer Risk Reduction (NCT NCT00204477)

NCT ID: NCT00204477

Last Updated: 2024-01-23

Results Overview

Breast images were acquired by digital mammography. Fibroglandular tissue were segmented from fatty breast tissue. The total breast area is the sum of the fibroglandular tissue area and fatty breast tissue area. Mammographic density (breast density) is the percentage of fibroglandular tissue in the total breast.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 321 participants
• Primary outcome timeframe: Baseline
• Results posted on: 2024-01-23

Participant Flow

Participant milestones

Measure	Soy Milk Subjects will consume two soy milk drinks from the content of 2 sachets (40 g isoflavone-free soy protein and 600 mg calcium) in place of a small meal, five days per week. Each sachet will contain 20 g soy protein and 300 mg calcium. Content of sachets will be mixed with \~1.6 liter of water for ingestion. soy milk: Each drink contained soy protein, fat, and carbohydrates calcium and phosphorous to give a total energy of 177.8 kcal. Subjects took two drinks per day.	Cow's Milk Subjects will consume two cow's milk drinks from the content of 2 sachets (40 g cow's milk protein, casein, and 600 mg calcium) in place of a small meal, five days per week. Each sachet will contain 20 g cow's milk protein and 300 mg calcium. Content of sachets will be mixed with \~1.6 liter of water for ingestion. Casein is free of ovarian hormones. cow's milk: Each drink contained casein, fat, carbohydrates, calcium and phosphorous to give a total energy of 178.6 kcal. Subjects took two drinks per day.
Baseline STARTED	161	160
Baseline COMPLETED	161	160
Baseline NOT COMPLETED	0	0
One Year After Diet STARTED	128	125
One Year After Diet COMPLETED	86	87
One Year After Diet NOT COMPLETED	42	38
Two Years After Diet STARTED	55	62
Two Years After Diet COMPLETED	39	49
Two Years After Diet NOT COMPLETED	16	13

Reasons for withdrawal

Measure	Soy Milk Subjects will consume two soy milk drinks from the content of 2 sachets (40 g isoflavone-free soy protein and 600 mg calcium) in place of a small meal, five days per week. Each sachet will contain 20 g soy protein and 300 mg calcium. Content of sachets will be mixed with \~1.6 liter of water for ingestion. soy milk: Each drink contained soy protein, fat, and carbohydrates calcium and phosphorous to give a total energy of 177.8 kcal. Subjects took two drinks per day.	Cow's Milk Subjects will consume two cow's milk drinks from the content of 2 sachets (40 g cow's milk protein, casein, and 600 mg calcium) in place of a small meal, five days per week. Each sachet will contain 20 g cow's milk protein and 300 mg calcium. Content of sachets will be mixed with \~1.6 liter of water for ingestion. Casein is free of ovarian hormones. cow's milk: Each drink contained casein, fat, carbohydrates, calcium and phosphorous to give a total energy of 178.6 kcal. Subjects took two drinks per day.
One Year After Diet Did not complete 1 year of diet	42	38
Two Years After Diet Did not complete the 2nd year of diet	16	13

Baseline Characteristics

Soy Protein and Breast Cancer Risk Reduction

Baseline characteristics by cohort

Measure	Soy Milk n=161 Participants Subjects will consume two soy milk drinks from the content of 2 sachets (40 g isoflavone-free soy protein and 600 mg calcium) in place of a small meal, five days per week. Each sachet will contain 20 g soy protein and 300 mg calcium. Content of sachets will be mixed with \~1.6 liter of water for ingestion. soy milk: Each drink contained soy protein, fat, and carbohydrates calcium and phosphorous to give a total energy of 177.8 kcal. Subjects took two drinks per day.	Cow's Milk n=160 Participants Subjects will consume two cow's milk drinks from the content of 2 sachets (40 g cow's milk protein, casein, and 600 mg calcium) in place of a small meal, five days per week. Each sachet will contain 20 g cow's milk protein and 300 mg calcium. Content of sachets will be mixed with \~1.6 liter of water for ingestion. Casein is free of ovarian hormones. cow's milk: Each drink contained casein, fat, carbohydrates, calcium and phosphorous to give a total energy of 178.6 kcal. Subjects took two drinks per day.	Total n=321 Participants Total of all reporting groups
Age, Customized Ages from 29 to 41	161 years n=5 Participants	0 years n=7 Participants	161 years n=5 Participants
Age, Customized Agesfrom 30 to 41	0 years n=5 Participants	160 years n=7 Participants	160 years n=5 Participants
Sex: Female, Male Female	161 Participants n=5 Participants	160 Participants n=7 Participants	321 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized American Indian/Alaskan	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Asian	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Race/Ethnicity, Customized Black/African American	21 Participants n=5 Participants	18 Participants n=7 Participants	39 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic or Latino	57 Participants n=5 Participants	71 Participants n=7 Participants	128 Participants n=5 Participants
Race/Ethnicity, Customized Other (>2 races)	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian	77 Participants n=5 Participants	66 Participants n=7 Participants	143 Participants n=5 Participants
Region of Enrollment United States	161 participants n=5 Participants	160 participants n=7 Participants	321 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline

Population: 4 participants images in the cow's milk and 3 images in soy milk were either missing or corrupt.

Breast images were acquired by digital mammography. Fibroglandular tissue were segmented from fatty breast tissue. The total breast area is the sum of the fibroglandular tissue area and fatty breast tissue area. Mammographic density (breast density) is the percentage of fibroglandular tissue in the total breast.

Outcome measures

Measure	Soy Milk n=157 Participants Subjects will consume two soy milk drinks from the content of 2 sachets (40 g isoflavone-free soy protein and 600 mg calcium) in place of a small meal, five days per week. Each sachet will contain 20 g soy protein and 300 mg calcium. Content of sachets will be mixed with \~1.6 liter of water for ingestion. soy milk: Each drink contained soy protein, fat, and carbohydrates calcium and phosphorous to give a total energy of 177.8 kcal. Subjects took two drinks per day.	Cow's Milk n=157 Participants Subjects will consume two cow's milk drinks from the content of 2 sachets (40 g cow's milk protein, casein, and 600 mg calcium) in place of a small meal, five days per week. Each sachet will contain 20 g cow's milk protein and 300 mg calcium. Content of sachets will be mixed with \~1.6 liter of water for ingestion. Casein is free of ovarian hormones. cow's milk: Each drink contained casein, fat, carbohydrates, calcium and phosphorous to give a total energy of 178.6 kcal. Subjects took two drinks per day.
Mammographic Density (Baseline)	29.21 percentage of glandular tissue in breast Standard Deviation 11.44	28.24 percentage of glandular tissue in breast Standard Deviation 11.77

PRIMARY outcome

Timeframe: 1 Year

Population: Participants completed one year of diet.

Breast images were acquired by digital mammography. Fibroglandular tissue were segmented from fatty breast tissue. The total breast area is the sum of the fibroglandular tissue area and fatty breast tissue area. Mammographic density (breast density) is the percentage of fibroglandular tissue in the total breast.

Outcome measures

Measure	Soy Milk n=86 Participants Subjects will consume two soy milk drinks from the content of 2 sachets (40 g isoflavone-free soy protein and 600 mg calcium) in place of a small meal, five days per week. Each sachet will contain 20 g soy protein and 300 mg calcium. Content of sachets will be mixed with \~1.6 liter of water for ingestion. soy milk: Each drink contained soy protein, fat, and carbohydrates calcium and phosphorous to give a total energy of 177.8 kcal. Subjects took two drinks per day.	Cow's Milk n=87 Participants Subjects will consume two cow's milk drinks from the content of 2 sachets (40 g cow's milk protein, casein, and 600 mg calcium) in place of a small meal, five days per week. Each sachet will contain 20 g cow's milk protein and 300 mg calcium. Content of sachets will be mixed with \~1.6 liter of water for ingestion. Casein is free of ovarian hormones. cow's milk: Each drink contained casein, fat, carbohydrates, calcium and phosphorous to give a total energy of 178.6 kcal. Subjects took two drinks per day.
Mammographic Density (1 Year)	29.37 percentage of glandular tissue in breast Standard Deviation 12.78	28.01 percentage of glandular tissue in breast Standard Deviation 11.56

PRIMARY outcome

Timeframe: 2 years

Population: Participants completed 2 years of study. 1 image missing from the cow's milk group due to it was corrupt.

Breast images were acquired by digital mammography. Fibroglandular tissue were segmented from fatty breast tissue. The total breast area is the sum of the fibroglandular tissue area and fatty breast tissue area. Mammographic density (breast density) is the percentage of fibroglandular tissue in the total breast.

Outcome measures

Measure	Soy Milk n=39 Participants Subjects will consume two soy milk drinks from the content of 2 sachets (40 g isoflavone-free soy protein and 600 mg calcium) in place of a small meal, five days per week. Each sachet will contain 20 g soy protein and 300 mg calcium. Content of sachets will be mixed with \~1.6 liter of water for ingestion. soy milk: Each drink contained soy protein, fat, and carbohydrates calcium and phosphorous to give a total energy of 177.8 kcal. Subjects took two drinks per day.	Cow's Milk n=48 Participants Subjects will consume two cow's milk drinks from the content of 2 sachets (40 g cow's milk protein, casein, and 600 mg calcium) in place of a small meal, five days per week. Each sachet will contain 20 g cow's milk protein and 300 mg calcium. Content of sachets will be mixed with \~1.6 liter of water for ingestion. Casein is free of ovarian hormones. cow's milk: Each drink contained casein, fat, carbohydrates, calcium and phosphorous to give a total energy of 178.6 kcal. Subjects took two drinks per day.
Mammographic Density (2 Years)	30.75 percentage of glandular tissue in breast Standard Deviation 13.26	29.06 percentage of glandular tissue in breast Standard Deviation 11.80

PRIMARY outcome

Timeframe: Baseline

Population: 4 participants images in the cow's milk and 14 images in soy milk were either missing or corrupt.

Breast images acquired by breast magnetic resonance imaging (MRI). The amount of fatty breast tissue,(cc), glandular breast tissue(cc ), total breast (cc), and percentage of glandular tissue in total breast (%) were estimated.

Outcome measures

Measure	Soy Milk n=147 Participants Subjects will consume two soy milk drinks from the content of 2 sachets (40 g isoflavone-free soy protein and 600 mg calcium) in place of a small meal, five days per week. Each sachet will contain 20 g soy protein and 300 mg calcium. Content of sachets will be mixed with \~1.6 liter of water for ingestion. soy milk: Each drink contained soy protein, fat, and carbohydrates calcium and phosphorous to give a total energy of 177.8 kcal. Subjects took two drinks per day.	Cow's Milk n=156 Participants Subjects will consume two cow's milk drinks from the content of 2 sachets (40 g cow's milk protein, casein, and 600 mg calcium) in place of a small meal, five days per week. Each sachet will contain 20 g cow's milk protein and 300 mg calcium. Content of sachets will be mixed with \~1.6 liter of water for ingestion. Casein is free of ovarian hormones. cow's milk: Each drink contained casein, fat, carbohydrates, calcium and phosphorous to give a total energy of 178.6 kcal. Subjects took two drinks per day.
Breast Tissue Composition Measured by MRI Fatty Breast Tissue, cc	589.9 cc Standard Deviation 333.5	628.1 cc Standard Deviation 373.4
Breast Tissue Composition Measured by MRI Glandular Breast Tissue, cc	153.4 cc Standard Deviation 84.48	156.7 cc Standard Deviation 88.75
Breast Tissue Composition Measured by MRI Total Breast, cc	743.3 cc Standard Deviation 350.9	784.9 cc Standard Deviation 400.8

PRIMARY outcome

Timeframe: 1 Year

Population: Participants completed year 1.

Breast images acquired by breast magnetic resonance imaging (MRI). The amount of fatty breast tissue,(cc), glandular breast tissue(cc ), total breast (cc), and percentage of glandular tissue in total breast (%) were estimated.

Outcome measures

Measure	Soy Milk n=86 Participants Subjects will consume two soy milk drinks from the content of 2 sachets (40 g isoflavone-free soy protein and 600 mg calcium) in place of a small meal, five days per week. Each sachet will contain 20 g soy protein and 300 mg calcium. Content of sachets will be mixed with \~1.6 liter of water for ingestion. soy milk: Each drink contained soy protein, fat, and carbohydrates calcium and phosphorous to give a total energy of 177.8 kcal. Subjects took two drinks per day.	Cow's Milk n=86 Participants Subjects will consume two cow's milk drinks from the content of 2 sachets (40 g cow's milk protein, casein, and 600 mg calcium) in place of a small meal, five days per week. Each sachet will contain 20 g cow's milk protein and 300 mg calcium. Content of sachets will be mixed with \~1.6 liter of water for ingestion. Casein is free of ovarian hormones. cow's milk: Each drink contained casein, fat, carbohydrates, calcium and phosphorous to give a total energy of 178.6 kcal. Subjects took two drinks per day.
Breast Tissue Composition Measured by MRI Fatty Breast Tissue, cc	587.4 cc Standard Deviation 341.8	626.1 cc Standard Deviation 358.9
Breast Tissue Composition Measured by MRI Glandular Breast Tissue, cc	159.3 cc Standard Deviation 89.72	156.7 cc Standard Deviation 83.06
Breast Tissue Composition Measured by MRI Total Breast, cc	746.7 cc Standard Deviation 358.8	782.8 cc Standard Deviation 387.5

PRIMARY outcome

Timeframe: 2 years

Breast images acquired by breast magnetic resonance imaging (MRI). The amount of fatty breast tissue,(cc), glandular breast tissue(cc ), total breast (cc), and percentage of glandular tissue in total breast (%) were estimated.

Outcome measures

Measure	Soy Milk n=39 Participants Subjects will consume two soy milk drinks from the content of 2 sachets (40 g isoflavone-free soy protein and 600 mg calcium) in place of a small meal, five days per week. Each sachet will contain 20 g soy protein and 300 mg calcium. Content of sachets will be mixed with \~1.6 liter of water for ingestion. soy milk: Each drink contained soy protein, fat, and carbohydrates calcium and phosphorous to give a total energy of 177.8 kcal. Subjects took two drinks per day.	Cow's Milk n=49 Participants Subjects will consume two cow's milk drinks from the content of 2 sachets (40 g cow's milk protein, casein, and 600 mg calcium) in place of a small meal, five days per week. Each sachet will contain 20 g cow's milk protein and 300 mg calcium. Content of sachets will be mixed with \~1.6 liter of water for ingestion. Casein is free of ovarian hormones. cow's milk: Each drink contained casein, fat, carbohydrates, calcium and phosphorous to give a total energy of 178.6 kcal. Subjects took two drinks per day.
Breast Tissue Composition Measured by MRI Fatty Breast Tissue, cc	629.9 cc Standard Deviation 406.5	615.5 cc Standard Deviation 395.9
Breast Tissue Composition Measured by MRI Glandular Breast Tissue, cc	173.8 cc Standard Deviation 104.5	152.7 cc Standard Deviation 87.44
Breast Tissue Composition Measured by MRI Total Breast, cc	803.7 cc Standard Deviation 420.8	768.2 cc Standard Deviation 426.4

PRIMARY outcome

Timeframe: Baseline

Population: 4 participants images in the cow's milk and 14 images in soy milk were either missing or corrupt.

Breast images acquired by breast magnetic resonance imaging (MRI). The amount of fatty breast tissue,(cc), glandular breast tissue(cc ), total breast (cc), and percentage of glandular tissue in total breast (%) were estimated.

Outcome measures

Measure	Soy Milk n=147 Participants Subjects will consume two soy milk drinks from the content of 2 sachets (40 g isoflavone-free soy protein and 600 mg calcium) in place of a small meal, five days per week. Each sachet will contain 20 g soy protein and 300 mg calcium. Content of sachets will be mixed with \~1.6 liter of water for ingestion. soy milk: Each drink contained soy protein, fat, and carbohydrates calcium and phosphorous to give a total energy of 177.8 kcal. Subjects took two drinks per day.	Cow's Milk n=156 Participants Subjects will consume two cow's milk drinks from the content of 2 sachets (40 g cow's milk protein, casein, and 600 mg calcium) in place of a small meal, five days per week. Each sachet will contain 20 g cow's milk protein and 300 mg calcium. Content of sachets will be mixed with \~1.6 liter of water for ingestion. Casein is free of ovarian hormones. cow's milk: Each drink contained casein, fat, carbohydrates, calcium and phosphorous to give a total energy of 178.6 kcal. Subjects took two drinks per day.
Percentage of Grandular Tissue in Total Breast Measured by MRI	24.27 % of glandular tissue in total breast Standard Deviation 13.64	24.09 % of glandular tissue in total breast Standard Deviation 15.83

PRIMARY outcome

Timeframe: 1 Year

Population: Participants completed year 1.

Breast images acquired by breast magnetic resonance imaging (MRI). The amount of fatty breast tissue,(cc), glandular breast tissue(cc ), total breast (cc), and percentage of glandular tissue in total breast (%) were estimated.

Outcome measures

Measure	Soy Milk n=86 Participants Subjects will consume two soy milk drinks from the content of 2 sachets (40 g isoflavone-free soy protein and 600 mg calcium) in place of a small meal, five days per week. Each sachet will contain 20 g soy protein and 300 mg calcium. Content of sachets will be mixed with \~1.6 liter of water for ingestion. soy milk: Each drink contained soy protein, fat, and carbohydrates calcium and phosphorous to give a total energy of 177.8 kcal. Subjects took two drinks per day.	Cow's Milk n=86 Participants Subjects will consume two cow's milk drinks from the content of 2 sachets (40 g cow's milk protein, casein, and 600 mg calcium) in place of a small meal, five days per week. Each sachet will contain 20 g cow's milk protein and 300 mg calcium. Content of sachets will be mixed with \~1.6 liter of water for ingestion. Casein is free of ovarian hormones. cow's milk: Each drink contained casein, fat, carbohydrates, calcium and phosphorous to give a total energy of 178.6 kcal. Subjects took two drinks per day.
Percentage of Grandular Tissue in Total Breast Measured by MRI	25.017 % of glandular tissue in total breast Standard Deviation 14.48	24.20 % of glandular tissue in total breast Standard Deviation 15.82

PRIMARY outcome

Timeframe: 2 years

Breast images acquired by breast magnetic resonance imaging (MRI). The amount of fatty breast tissue,(cc), glandular breast tissue(cc ), total breast (cc), and percentage of glandular tissue in total breast (%) were estimated.

Outcome measures

Measure	Soy Milk n=39 Participants Subjects will consume two soy milk drinks from the content of 2 sachets (40 g isoflavone-free soy protein and 600 mg calcium) in place of a small meal, five days per week. Each sachet will contain 20 g soy protein and 300 mg calcium. Content of sachets will be mixed with \~1.6 liter of water for ingestion. soy milk: Each drink contained soy protein, fat, and carbohydrates calcium and phosphorous to give a total energy of 177.8 kcal. Subjects took two drinks per day.	Cow's Milk n=49 Participants Subjects will consume two cow's milk drinks from the content of 2 sachets (40 g cow's milk protein, casein, and 600 mg calcium) in place of a small meal, five days per week. Each sachet will contain 20 g cow's milk protein and 300 mg calcium. Content of sachets will be mixed with \~1.6 liter of water for ingestion. Casein is free of ovarian hormones. cow's milk: Each drink contained casein, fat, carbohydrates, calcium and phosphorous to give a total energy of 178.6 kcal. Subjects took two drinks per day.
Percentage of Grandular Tissue in Total Breast Measured by MRI	26.39 % of glandular tissue in total breast Standard Deviation 15.52	24.25 % of glandular tissue in total breast Standard Deviation 15.89

OTHER_PRE_SPECIFIED outcome

Timeframe: 4 measurements at baseline and once every three months after protein drink supplements for up to 2 years.

Serum will be measured for for blood chemistries , 4 times at baseline, and thereafter at 3-monthly interval for up to 2 years of protein drink supplementation

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 4 measurements at baseline and once every three months after protein drink supplements for up to 2 years.

Serum will be measured for progesterone (ng/ml), 4 times at baseline, and thereafter at 3-monthly interval for up to 2 years of protein drink supplementation

Outcome measures

Outcome data not reported

Adverse Events

Soy Milk

Serious events: 0 serious events

Other events: 28 other events

Deaths: 0 deaths

Cow's Milk

Serious events: 0 serious events

Other events: 21 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Soy Milk n=161 participants at risk Subjects will consume two soy milk drinks from the content of 2 sachets (40 g isoflavone-free soy protein and 600 mg calcium) in place of a small meal, five days per week. Each sachet will contain 20 g soy protein and 300 mg calcium. Content of sachets will be mixed with \~1.6 liter of water for ingestion. soy milk: Each drink contained soy protein, fat, and carbohydrates calcium and phosphorous to give a total energy of 177.8 kcal. Subjects took two drinks per day.	Cow's Milk n=160 participants at risk Subjects will consume two cow's milk drinks from the content of 2 sachets (40 g cow's milk protein, casein, and 600 mg calcium) in place of a small meal, five days per week. Each sachet will contain 20 g cow's milk protein and 300 mg calcium. Content of sachets will be mixed with \~1.6 liter of water for ingestion. Casein is free of ovarian hormones. cow's milk: Each drink contained casein, fat, carbohydrates, calcium and phosphorous to give a total energy of 178.6 kcal. Subjects took two drinks per day.
Musculoskeletal and connective tissue disorders accident	0.62% 1/161 • 2 years	0.00% 0/160 • 2 years
Gastrointestinal disorders appendectomy	0.62% 1/161 • 2 years	0.00% 0/160 • 2 years
Cardiac disorders hypertension	0.62% 1/161 • 2 years	0.00% 0/160 • 2 years
Eye disorders blurred vision	0.62% 1/161 • 2 years	0.00% 0/160 • 2 years
Nervous system disorders optic migraines	0.62% 1/161 • 2 years	0.00% 0/160 • 2 years
Reproductive system and breast disorders Heavy bleeding and uterine polyp	0.62% 1/161 • 2 years	0.00% 0/160 • 2 years
Surgical and medical procedures cholecystectomy	1.2% 2/161 • 2 years	0.00% 0/160 • 2 years
Pregnancy, puerperium and perinatal conditions pregnancy	3.1% 5/161 • 2 years	2.5% 4/160 • 2 years
Renal and urinary disorders urinary tract infection and kidney stones	0.62% 1/161 • 2 years	0.00% 0/160 • 2 years
General disorders fever, abdominal pain, leucopenia of unknown etiology	0.62% 1/161 • 2 years	0.00% 0/160 • 2 years
Infections and infestations strep throat	0.62% 1/161 • 2 years	0.62% 1/160 • 2 years
Reproductive system and breast disorders enlarged uterus and large fibroids	0.62% 1/161 • 2 years	0.00% 0/160 • 2 years
Blood and lymphatic system disorders idiopathic thrombocytopanic purpura	0.62% 1/161 • 2 years	0.00% 0/160 • 2 years
Nervous system disorders mild stroke	0.62% 1/161 • 2 years	0.00% 0/160 • 2 years
Infections and infestations adenopathy in both axilla	0.62% 1/161 • 2 years	0.00% 0/160 • 2 years
Surgical and medical procedures ovariectomy (1) and follipian tube removed	0.00% 0/161 • 2 years	0.62% 1/160 • 2 years
Infections and infestations fever, earache, and hearing loss in left ear	0.00% 0/161 • 2 years	0.62% 1/160 • 2 years
Infections and infestations bladder infection	0.00% 0/161 • 2 years	0.62% 1/160 • 2 years
Musculoskeletal and connective tissue disorders accident, fall, rib broke, ankle sprained	0.00% 0/161 • 2 years	0.62% 1/160 • 2 years
Skin and subcutaneous tissue disorders right breast lump	0.00% 0/161 • 2 years	0.62% 1/160 • 2 years
Surgical and medical procedures recurrent endometriosis, surgery	0.00% 0/161 • 2 years	0.62% 1/160 • 2 years
Infections and infestations tosillitis and UTI	0.00% 0/161 • 2 years	0.62% 1/160 • 2 years
Musculoskeletal and connective tissue disorders sprain/fracture wrist	0.00% 0/161 • 2 years	0.62% 1/160 • 2 years
Blood and lymphatic system disorders blood nipple, one	0.00% 0/161 • 2 years	0.62% 1/160 • 2 years
Surgical and medical procedures laparoscopic lap band elective surgery	0.00% 0/161 • 2 years	0.62% 1/160 • 2 years
Immune system disorders allergic reaction	0.00% 0/161 • 2 years	0.62% 1/160 • 2 years
Reproductive system and breast disorders fibroid, irregular bleeding	0.00% 0/161 • 2 years	0.62% 1/160 • 2 years
Surgical and medical procedures goiter surgery	0.00% 0/161 • 2 years	0.62% 1/160 • 2 years
General disorders tattoos removal	0.00% 0/161 • 2 years	0.62% 1/160 • 2 years
Reproductive system and breast disorders fibroadnoma of right breast	0.00% 0/161 • 2 years	0.62% 1/160 • 2 years
Reproductive system and breast disorders uterus, laproscopy, D&C	0.62% 1/161 • 2 years	0.00% 0/160 • 2 years
Reproductive system and breast disorders cervix, polyp, bacterial vaginosis	0.62% 1/161 • 2 years	0.00% 0/160 • 2 years
Infections and infestations leucopenia, fever, abdominal pain	0.62% 1/161 • 2 years	0.00% 0/160 • 2 years
General disorders accident	0.62% 1/161 • 2 years	0.00% 0/160 • 2 years
Reproductive system and breast disorders pre existing abnormal pap	0.62% 1/161 • 2 years	0.00% 0/160 • 2 years
Reproductive system and breast disorders leiomyomata	0.62% 1/161 • 2 years	0.00% 0/160 • 2 years
Reproductive system and breast disorders Breast calcification, increase	0.00% 0/161 • 2 years	0.62% 1/160 • 2 years
Skin and subcutaneous tissue disorders Basal cell carcinoma	0.62% 1/161 • 2 years	0.00% 0/160 • 2 years

Additional Information

Leejane W. Lu

University of Texas Medical Branch Galveston

Phone: (409)772-1011

Email: llu@utmb.edu

Results disclosure agreements

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