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Estrogen Deficiency clinical trials

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NCT ID: NCT06343870 Not yet recruiting - Menopause Clinical Trials

Estradiol and Testosterone Subdermal Implants for Menopause Treatment (ESTIME)

ESTIME
Start date: May 31, 2024
Phase: Phase 3
Study type: Interventional

Estrogen and androgen deficiencies negatively impact the quality of life of women at different stages of life, especially after menopause. New modalities and new therapeutic alternatives have been researched. Parenteral administration of estradiol and testosterone could be effective to treat symptoms secondary to estrogen and androgen deficiencies and minimize these adverse events. This study evaluates the efficiency of subdermal implant-bioabsorbable use in women with menopausal symptoms associated with secondary estrogen and androgen deficiencies in women with natural menopause, premature ovarian failure or surgical menopause due to cervical cancer. Pharmacokinetic, biochemical, metabolic, thromboembolic and hormonal data will be evaluated, as well as the effects on quality of life, menopausal symptoms and sexual function after treatment.

NCT ID: NCT04513405 Not yet recruiting - Estrogen Deficiency Clinical Trials

Estrogens Levels and Receptors Status and Skin Tears

ESKITE
Start date: September 1, 2020
Phase: N/A
Study type: Interventional

Background: Skin tears (ST) or "laceration injuries" or "flap wounds" are injuries that are often found in residents of residential care facilities (RCFs). STs were first defined by Payne and Martin in 1993 as traumatic wounds, located mainly in the upper limbs, caused by "shearing, friction or mechanisms combined with the consequent separation of layers of skin. Skin Tears can cause psychological problems for the patient and represent an economic problem with important repercussions on both the patient and the community. The etiology suggests that the physiological changes of the skin related to old age, together with comorbidity, are among the main risk factors for their onset. The precise data on the phenomenon are not many, but it is estimated that STs are much more frequent than the same pressure ulcers, observing prevalence rates in RCFs around 40% Therefore, there are several risk factors hypothesized so far. Much evidence has correlated, in various physiological or pathological conditions, the role of estrogens with the functions and aging of the skin. Objectives: The project will develop on the analysis of populations of residents from RCFs belonging to the national territory. Two populations of residents cared in the RCF will be recruited. A group of subjects suffering from skin tears (group A) and a control group of subjects without skin tears (group B). The inclusion of patients in both groups will take place through a simple randomization procedure. Group A patients will be staged according to the STAR classification for skin tears. For each group a peripheral venous blood sample will be taken (to measure the levels of estrone and estradiol) and a skin biopsy will be performed in order to measure estrogen receptors (ERs) expression. A data collection sheet with angraphic and anamnestic data will be developed to correlate the demographic and comorbidity data with the clinical conditions of the patients and with the laboratory findings from the sampling. Expected results: The primary endpoint will be the correlation between serum estrogen levels, receptor expression and the presence of skin tears. The secondary endopoint will be Correlation between receptor structure and clinical staging of skin tears. Future prospectives: We believe that our study may open new frontiers in the prevention and in the management of these skin lesions.

NCT ID: NCT04245527 Not yet recruiting - Clinical trials for Testosterone Deficiency

Use of Infrared Photomodulation for Hormonal Balance (Joovvin' for Hormonal Health)

Start date: January 31, 2020
Phase: N/A
Study type: Interventional

8-week pilot study looking at the impact of Joovv's infrared photo modulation product on male and female hormone levels.