This trial is evaluating whether Levothyroxine will improve 3 primary outcomes and 1 other outcome in patients with Hypothyroidism. Measurement will happen over the course of Baseline to 6 months post surgery.
This trial requires 30 total participants across 2 different treatment groups
This trial involves 2 different treatments. Levothyroxine is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are in Phase 2 and have already been tested with other people.
Hypothyroidism is a condition in which the thyroid does not produce enough thyroid hormones, known as Tl. Symptoms of hypothyroidism include fatigue, weight gain, feeling tired and depression. Hypothyroidism can occur during pregnancy to help give birth to a healthy baby.\n
Rates of [hypothyroidism](https://www.withpower.com/clinical-trials/hypothyroidism) are about seven per 100,000 women in the United States each year. Rates are higher among minorities. Thyroiditis in pregnancy can lead to postpartum hypothyroidism in at least 10 percent of treated women.
Thyroid replacement therapy is recommended for the treatment of subacute thyroid failure. It has been shown to be safe and effective; in selected cases it can result in an improvement in the subjective symptoms of the patient.
The main cause of [hypothyroidism](https://www.withpower.com/clinical-trials/hypothyroidism) is not known, but there are risks to both men and women because of various habits and diseases. For example, thyroid disorders can develop and be triggered by certain drugs like steroids and aspirin. Hypothyroidism is a rare but well-understood condition; so, in the future, better diagnostics and treatment methods might be developed for the treatment of it.
The symptoms of hypothyroidism include excessive fatigue, weight gain, changes in menstrual cycles, changes in hair coloring, loss of energy and feeling tired. Other signs consist of depressed mood, impaired concentration, lethargy, irregular sleep rhythms and muscle pains.\n
In most cases [hypothyroidism](https://www.withpower.com/clinical-trials/hypothyroidism) is treated with thyroid hormone replacement treatment. In the event of nonalcoholic diabetes mellitus, or in patients with cardiovascular risk factors such as hypertension, cholesterol level must be controlled more cautiously by lipid lowering drugs and anti-hypertensive medicines, until the effects of hypothyroidism are reversed. A thyroid functional and hormone examination must be carried out, to exclude sub-clinical hypothyroidism. In cases of severe hypothyroidism, one may consider treatment with thyroid stimulating hormone (TSH) releasing hormone. This treatment does not require an end-point of its own and thus it is often only carried out in people who are incapable of having their TSH level properly measured.
The current study shows that the new drug products are comparable to standard and/or patented levothyroxine. The levothyroxine used has been approved for therapeutic use in the European Union and Australia. The new levothyroxine drug products have been approved for therapeutic use in several countries and are being prescribed for different indications.
Levothyroxine reduces serum TSH concentration by a predictable degree; serum FT4 concentration rises in some patients during dose titration. The increase is not due to increased SHBG production by the liver; it is due to increased production of FT4 by the thyroid. During long-term administration of levothyroxine, circulating levels of FT4 and T3 in both genders remain similar when taken in a conventional (daily) or a low-frequency (periodic) dosage, unless TSH levels are suppressed to a borderline low.
Although many studies of FT4 level and levothyroxine in patients with T3 deficiency exist, none of these trials, including the largest--Toumey's, have addressed the specific clinical concerns raised by Levitt and colleagues--namely, treatment delay, the presence of other symptoms, and the effects of levothyroxine treatment after surgical correction of nodule size have been previously reported. This is the first report that demonstrates a positive result using levothyroxine for the treatment of T3 deficiency or hypothyroidism.
It may be an absolute contraindication to any kind of surgical procedures, although it's important to take into account the severity of the underlying symptoms in the decision-making process. If thyroid function remains impaired, patients should be aware of the possible adverse effects of long-term thyroxine therapy on cardiovascular functioning (e.g. dyslipidemia and worsening of glucose tolerance) although they may not manifest themselves as long as these medications are taken in the requisite doses. However, cardiovascular symptoms may be present in the first 2‐3 years after thyroid replacement and the risks should be duly weighed against the need for further treatment.
levothyroxine is associated with improvements in quality of life at least as good as those reported in previous research for thyroid replacement therapy. Levothyroxine may therefore be suitable for use in the treatment of hypothyroidism.
Hypothyroidism has been known to affect the nervous system and cardiovascular system in humans. For example, in rats, hypothyroidism was shown to cause an increase in anxiety, and a loss of attention and short long term memory. These same changes have also been found in humans. As of 2013, a few studies have been performed into the links between hypothyroidism and human mental health. However, studies in animals have generally not been replicated in humans, despite many studies and observational data hinting at such links. In 2013, a systematic review looking at the links between hypothyroidism, depression, and cognitive performance was published. Though this review has limitations (e.g.