NCT03094416
Levothyroxine Sodium in Thyroidectomized Patients Taking Proton Pump Inhibitors
See it on ClinicalTrials.gov ↗47 people
76.6%
23.4%
36 womenmiddle line = equal numbers11 men
- Phase
- PHASE4
- Paid for by
- IBSA Institut Biochimique SA
- Finished
- 2020-06-15
- Health conditions
- Hypothyroidism;Postablative
- Who could join
- Anyone
- Ages
- 18 Years – 65 Years
- Average age
- mean 55.38 years
- Age 65+
- Not reported
- Weight (BMI)
- mean 32.25 kg/m^2
- Pregnancy recorded
- Not reported
- Menopause recorded
- Not reported
- Results shown by sex
- Some results split by sex
- Race
- White 68.1% · Black / African American 12.8% · Other 6.4% · Asian 6.4% · More than one race 2.1% · American Indian / Alaska Native 2.1% · Hispanic / Latina 2.1%
Women left out
- No pregnant women
Women who were pregnant could not join.
“pregnant (positive urine pregnancy test at screening or baseline visits) or breast-feeding subject or subject planning a pregnancy in the next months;”
- No breastfeeding moms
Women who were breastfeeding could not join.
“pregnant (positive urine pregnancy test at screening or baseline visits) or breast-feeding subject or subject planning a pregnancy in the next months;”
- Had to use birth control
Women who couldn't or didn't want to use birth control were turned away.
“for women, adequate and continuative contraceptive measures until the end of the study, if not in menopause;”
- No kidney or liver problems
Women with kidney or liver problems were turned away.
“….g. cardiac heart failure, active arrhythmia or history of arrhythmia, particularly atrial fibrillation, uncompensated diabetes mellitus, uncorrected adrenal insufficiency, seriously compromised hepatic, renal and/or respiratory functions);”
- No heart disease
Women with heart disease, heart rhythm problems or a past heart attack were turned away.
“multiple co-morbidities (e.g. cardiac heart failure, active arrhythmia or history of arrhythmia, particularly atrial fibrillation, uncompensated diabetes mellitus, uncorrected adrenal insufficiency, seriously compromised hepatic, renal and/…”
- No diabetes
Women with diabetes were turned away.
“….g. cardiac heart failure, active arrhythmia or history of arrhythmia, particularly atrial fibrillation, uncompensated diabetes mellitus, uncorrected adrenal insufficiency, seriously compromised hepatic, renal and/or respiratory functions);”
- No mental health conditions
Women with depression, bipolar disorder or other mental health conditions were turned away.
“history of alcoholism, drug abuse or psychiatric diseases that could invalidate the informed consent or limit the subject compliance with protocol requirements;”
Study titles and rules are shown in their original English.