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Hormone Deficiency clinical trials

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NCT ID: NCT06242535 Active, not recruiting - Obesity Clinical Trials

Pilot Study of GLY-LOW Supplementation in Postmenopausal Women With Obesity

Start date: July 27, 2023
Phase: Early Phase 1
Study type: Interventional

A combination of generally regarded as safe (GRAS) compounds named GLY-LOW, which included: alpha lipoic acid, pyridoxamine, nicotinamide, piperine and thiamine, were examined in pre-clinical experiments. GLY-LOW supplementation reduced caloric intake and increased insulin sensitivity in mice. In female mice, GLY-LOW supplementation reversed aging-related declines in female hormones. Studies in humans are needed to examine the feasibility, utility and efficacy of GLY-LOW supplementation in post-menopausal women with obesity toward improving aging-related impairments. The effect of GLY-LOW supplementation on these obesity and biological age-related impairments in post-menopausal adult female humans with obesity is unknown. We aim to translate the findings of GLY-LOW supplementation in animals to a cohort of healthy, postmenopausal females at birth with obesity by conducting a one-group, no-placebo comparer, pre post intervention clinical trial. Additionally, we propose to examine the specific effect of supplementation by GLY-LOW on biological aging via retina scan. The objectives of the proposed pilot study are: I. Conduct a 6-month pilot study to examine the feasibility, utility and efficacy of GLY-LOW supplementation in a total of 40 postmenopausal female born adults > 55 years with obesity (> 30 BMI) Ia. Examine alterations in self-reported caloric intake and the following health and biological aging, parameters prior to and after 6 months of GLY-LOW supplementation: 1. Self-reported Caloric Intake 2. Metabolic disease risk 3. Cardiovascular disease risk 4. Metabolic assessments 5. Hormones 6. Physical Function and Fitness 7. Muscular strength 8. Cognitive Function and Depression assessments 9. Systemic inflammation 10. Biological aging 11. Safety parameters (also every 2 months during the intervention; ECG at baseline and 2 months only) 12, Compliance measures (pill counts and interviews every 2 months during the intervention)

NCT ID: NCT05171855 Active, not recruiting - Clinical trials for Endocrine System Diseases

A Trial to Investigate Long Term Efficacy and Safety of Lonapegsomatropin in Adults With Growth Hormone Deficiency

Start date: December 16, 2021
Phase: Phase 3
Study type: Interventional

This is a phase 3 open-label multicenter extension study designed to evaluate the long-term safety and efficacy of Lonapegsomatropin administered once-weekly. The study participants are adults (males and females) with confirmed growth hormone deficiency (GHD) having completed the treatment period in study TCH-306 (foresiGHt).

NCT ID: NCT05110391 Completed - Male Infertility Clinical Trials

Sperm Retrieval Rates in Non-obstructive Azoospermic Men Subjected to Gonadotropin Therapy

Start date: February 1, 2014
Phase:
Study type: Observational

Azoospermia is defined as the complete absence of spermatozoa in the ejaculate. Two-thirds of azoospermic patients have non-obstructive azoospermia (NOA); the latter comprises up to 10% of infertile men overall. NOA is an untreatable testicular disorder associated with spermatogenic failure and is the most severe male infertility phenotype. Among the available surgical sperm retrieval techniques, microdissection testicular sperm extraction (micro-TESE) is the procedure of choice due to its high sperm retrieval success rates (SRR), minimal tissue extraction, and low complication rates. Even with the use of micro-TESE, the likelihood of retrieving sperm in patients with NOA remain suboptimal (40% to 60%). Hypogonadism is detected in approximately half of the patients with NOA. Given the role of intratesticular testosterone (ITT) levels for spermatogenesis, some studies have explored the clinical utility of testosterone optimization by medical therapy before sperm retrieval. Moreover, some investigators have hypothesized that the follicle-stimulating hormone (FSH) reset might increase the expression of FSH receptors and improve Sertoli cell function. Hormonal therapy with human chorionic gonadotropin (hCG) has been shown to improve ITT production and decrease FSH levels in patients with NOA. The investigators, therefore, designed an observational cohort study aiming to evaluate whether hormone stimulation with gonadotropins (e.g., hCG alone or combined with FSH) previous to micro-TESE increases sperm retrieval rates in hypogonadal infertile men with NOA, candidates for sperm retrieval. The investigators hypothesize that optimizing ITT production and resetting FSH levels may improve spermatogenesis and successful sperm recovery.

NCT ID: NCT05033366 Enrolling by invitation - Pregnancy Related Clinical Trials

Relationship Between Fertility Hormone Patterns and Pregnancy Rates.

Start date: March 1, 2020
Phase:
Study type: Observational [Patient Registry]

The purpose of this study is to determine if certain patterns of hormone levels during the menstrual cycle are correlated with different pregnancy outcomes.

NCT ID: NCT04795570 Recruiting - Fibrosis Clinical Trials

Urethral Stricture After Transurethral Resection of the Prostate/Bladder: a Prospective Study of Risk Factors

STRICT-TURP
Start date: September 1, 2020
Phase:
Study type: Observational

There is currently no prognostic or predictive risk marker for this urethral stricture disease. The most conservative standard treatment for urethral stricture (internal urethrotomy) has a very high recurrence rate (greater than 75%) and, on many occasions, reconstructive urologists have to choose within a great variety of further complex interventions. Knowing risk and predictive markers of this disease could help to optimize both the need and the approach for these surgeries and may offer a more individualized management to patients.

NCT ID: NCT04615273 Completed - Clinical trials for Growth Hormone Deficiency

A Trial to Compare the Efficacy and Safety of Once-weekly Lonapegsomatropin With Placebo and a Daily Somatropin Product in Adults With Growth Hormone Deficiency

foresiGHt
Start date: December 3, 2020
Phase: Phase 3
Study type: Interventional

A 38 week dosing trial of lonapegsomatropin, a long-acting growth hormone product, administered once-a-week versus placebo-control. A daily somatropin product arm is also included to assist clinical judgement on the trial results. Approximately 240 adults (males and females) with growth hormone deficiency will be included. Randomization will occur in a 1:1:1 ratio (lonapegsomatropin : placebo : daily somatropin product). This is a global trial that will be conducted in, but not limited to, the United States, Europe, and Asia.

NCT ID: NCT04518930 Completed - Body Weight Clinical Trials

High Fat vs High Protein and Appetite Hormones

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

This study will investigate the effects of high-protein, high-fat snacks, specifically Greek yogurt, and peanuts, on satiety, gut hormones, and insulin secretion in overweight and obese women. The hypothesis posited that peanuts will exhibit a more beneficial impact on satiety, gut hormones, and insulin levels compared to Greek yogurt. The two-arm parallel randomized trial will involve 52 participants aged 30 to 40 with a BMI between 25-35 kg/m²,and they will be randomly divided into peanut (n=26) and Greek yogurt (n=26) groups. Pre-snack, BMI and dietary intake will be assessed. Appetite sensations will be gauged using a visual analog scale (VAS) upon arrival, and at 30- and 60-minutes post-snack. Pre- and post-snacking, plasma levels of cholecystokinin (CCK), Peptide Tyrosine-Tyrosine (PYY), Glucagon Like Peptide-1 (GLP-1), Ghrelin (GHRL), and insulin will be analyzed.

NCT ID: NCT04460872 Recruiting - Clinical trials for Spinal Cord Injuries

Locomotor Training With Testosterone to Promote Bone and Muscle Health After Spinal Cord Injury

Start date: January 31, 2021
Phase: Phase 2
Study type: Interventional

This pilot study will determine the feasibility of implementing a combinatory rehabilitation strategy involving testosterone replacement therapy (TRT) with locomotor training (LT; walking on a treadmill with assistance and overground walking) in men with testosterone deficiency and walking dysfunction after incomplete or complete spinal cord injury. The investigators hypothesize that LT+TRT treatment will improve muscle size and bone mineral density in men with low T and ambulatory dysfunction after incomplete or complete SCI, along with muscle fundtion and walking recovery in men with T low and ambulatory dysfunction ater incomplete SCI.

NCT ID: NCT03967964 Completed - Pharmacokinetics Clinical Trials

Pharmacokinetics of a Novel Vaginal Delivery System for Testosterone and Dehydroepiandrosterone (DHEA)

Start date: November 20, 2015
Phase: Phase 1
Study type: Interventional

This study was performed to determine the pharmacokinetic parameters of vaginal rings that contain DHEA, testosterone, or combinations of both androgens, in comparison to the oral administration of DHEA and the transdermal administration of testosterone.

NCT ID: NCT03856268 Withdrawn - Adiposity Clinical Trials

Understanding the Roles of Hormones in Adipocyte Remodeling Following Menopause

RESUME-2
Start date: April 1, 2019
Phase:
Study type: Observational

The overarching aims of this study are to: 1. Characterize the rate of in vivo adipogenesis, and changes in adipose tissue gene and protein expression, in the scABD and scFEM depots of women undergoing surgical menopause (↓E2, ↑FSH). 2. Characterize the rate of in vivo adipogenesis, and changes in adipose tissue gene and protein expression, in the scABD and scFEM depots of women undergoing gonadal suppression (↓E2, ↓FSH).