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Hypothalamic Amenorrhea clinical trials

View clinical trials related to Hypothalamic Amenorrhea.

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NCT ID: NCT05633966 Recruiting - Clinical trials for Hypogonadotropic Hypogonadism

Kisspeptin Administration Subcutaneously to Patients With Reproductive Disorders

KASPR
Start date: December 16, 2022
Phase: Phase 1
Study type: Interventional

The goal of this study is to see whether kisspeptin, a naturally occurring hormone, can stimulate the release of other reproductive hormones in women with hypothalamic amenorrhea (HA). The investigators are also examining whether kisspeptin can help women release eggs from their ovaries. Kisspeptin will be administered subcutaneously (SC) for two weeks in a pulsatile fashion. Ultrasound monitoring of ovarian follicular growth and frequent blood sampling (every 10 minutes for up to two hours) will be performed to assess the physiologic response to kisspeptin over time.

NCT ID: NCT05629377 Recruiting - Clinical trials for Hypothalamic Amenorrhea

Hypothalamic Amenorrhea as a Fertility Status Marker for Cardiovascular Health (ARCH)

ARCH
Start date: January 17, 2023
Phase:
Study type: Observational

Hypothalamic amenorrhea (HA) occurs during reproductive years and results in stopped menstrual cycles and infertility which can be prolonged from months to years and is characterized by varying combinations of psychosocial stress, anxiety, high levels of physical activity, and/or weight loss. Data from our group indicates that one-third of women with HA (mean age: 27 yrs) have preclinical cardiovascular disease (CVD) measured noninvasively as vascular dysfunction and vascular inflammation. This study will use HA as a marker of fertility status for cardiovascular health and perform dense-phenotyping using remote patient monitoring (FitBit) and patient reported outcomes (questionnaires) to determine which HA phenotypes are related to preclinical CVD and inflammation.

NCT ID: NCT03841981 Recruiting - Clinical trials for Polycystic Ovary Syndrome

Body Fat as Determinant of Female Gonadal Dysfunction

Start date: January 31, 2020
Phase:
Study type: Observational

Reproduction requires from women enough energy depots to warrant an adequate nutritional supply to the fetus. Hence, adipose tissue is able to communicate with female hypothalamic-pituitary-ovary axis. The hypothesis of the project is that abnormalities in the quantity (absolute and relative to lean body mass), distribution and/or function of adipose tissue are associated with functional forms of female gonadal dysfunction in predisposed women, in a spectrum of anomalies that go from hypothalamic amenorrhea to the polycystic ovary syndrome (PCOS). To challenge this hypothesis, the investigators will study 5 groups of 10 women each: women with exercise-associated hypothalamic amenorrhea, women without ovulatory dysfunction that exercise equally, non-hyperandrogenic patients with PCOS, hyperandrogenic patients with PCOS, and healthy control women comparable to those with PCOS. The aims of the study will be: Primary objective: To identify novel signalling factors originating from adipose tissue and muscle using targeted and nontargeted evaluation of the proteome and of gene expression of superficial subcutaneous fat, deep subcutaneous fat (which mimics visceral adipose tissue) and skeletal muscle. Secondary objectives: 1. To study the serum adipokine profile - including those identified by the primary objective - and circulating gut hormones during fasting and after a glucose load in the 5 groups of women, and their associations with sexual hormones and body fat distribution. 2. To study body composition and body fat distribution in these women and their relationships with: 2.1, Sex steroid profiles. 2.2. Classic cardiovascular risk factors: carbohydrate metabolism, lipid profiles and blood pressure. 2.3 Markers of low-grade chronic inflammation. 2.4. Oxidative stress markers. 2.5. Cardiovascular autonomic function. 2.6. Surrogate markers of subclinical atherosclerosis. 2.7. Circulating concentrations of endocrine disruptors. 2.8. Oral and gut microbiome. The results will provide a better understanding of the mechanisms linking body energy depots with the female reproductive axis and, hopefully, the identification of potential biomarkers for the diagnosis and treatment of the disorders studied here.

NCT ID: NCT03018366 Completed - Clinical trials for Cardiovascular Disease (CVD)

Atherosclerosis, Immune Mediated Inflammation and Hypoestrogenemia in Young Women

Start date: January 1, 2017
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine whether low estrogen levels in young women with hypothalamic amenorrhea (premenopausal HypoE) is associated with risk factors for cardiovascular disease. For this study, the investigators will measuring vascular function and immune markers on: - young women with hypothalamic amenorrhea (>3 months of no menstrual cycle due to low estrogen) - young women with regular menstrual cycles not on hormone therapy. - recently menopausal women (<3 years from final menstrual period) not on hormone therapy. Premenopausal HypoE participants will then be randomized to use either an estrogen patch or a placebo patch (no active medicine) for 3 months, followed by estrogen or placebo patch plus progesterone or placebo pills for 2 additional weeks. The investigators are looking to see if estrogen improves vascular and immune function.

NCT ID: NCT02984696 Recruiting - Clinical trials for Hypothalamic Amenorrhea

Total Antioxidant Capacity Before and After HRT in Hypotalamic Amenorrhea

Start date: March 2015
Phase: N/A
Study type: Interventional

The aim of our study is to investigate the effects of 6 months oh HRT on total anti-oxidant capacity, clinical, endocrine and metabolic features in women affected by hypotalamic amenorrhea. The study group included 20 patients treated with 1 mg of transdermal estradiol daily and 10mg of oral Medroxyprogesterone acetate from 16th to 24th day of therapy for six months. Menstrual pattern, anthropometric parameters, hormonal assays, DXA and bone metabolism parameters are evaluated before and after therapy.

NCT ID: NCT01601171 Recruiting - Clinical trials for Cleft Lip and Palate

Genetics of Reproductive Disorders (Including Kallmann Syndrome) and Cleft Lip and/or Palate

Start date: March 2012
Phase:
Study type: Observational

The purpose of this study is to explore the genetic basis of reproductive disorders and cleft lip and/or palate.

NCT ID: NCT01165619 Terminated - Clinical trials for Idiopathic Hypogonadotropic Hypogonadism

Detailed Clinical, Biochemical and Genetic Characterization in Gonadotropin-releasing Hormone (GnRH) Deficiency Disorders

Start date: June 2010
Phase: N/A
Study type: Observational

In this study, we will measure levels of reproductive hormones and metabolic markers in subjects with isolated GnRH deficiency disorders and compare them to healthy control populations. Our goals are (1) to chart the range of hormonal and metabolic biomarkers in healthy subjects and those with reproductive disorders and (2) to correlate reproductive and metabolic phenotypes with genetic changes within patients with reproductive disorders and healthy controls.

NCT ID: NCT00889512 Terminated - Infertility Clinical Trials

The Luveris In Vitro Fertilization Trial

Start date: April 2009
Phase: Phase 4
Study type: Interventional

The purpose of this study is to develop a new protocol using two different types of fertility drugs that is more similar to the way the hormones act in a normal menstrual cycle (period). We are recruiting women who are trying to get pregnant through In Vitro Fertilization (IVF) who either have a high prolactin level (a hormone normally found in your blood that is produced in the brain) or have a condition known as hypothalamic amenorrhea in which one does not get regular periods due to low hormone levels. The ovaries can be stimulated with Follicle Stimulating Hormone (FSH) alone and with FSH and Luteinizing Hormone (LH). FSH causes eggs to be made while LH causes estrogen (hormone) production. The women in this study have low hormone levels and need both FSH and LH. Luveris® (LH hormone) is a new drug approved for egg production and is used in IVF. There is no set amount of LH nor a set protocol for LH use. Therefore, we are testing this new regimen. One group of women will receive a fixed dose of LH throughout their cycle while the other will decrease the dose of FSH while at the same time increasing the LH dose which is what happens in the natural menstrual cycle.

NCT ID: NCT00556036 Completed - Obesity Clinical Trials

Hormone Dynamics and Bone Mineral Density in Anorexia Nervosa v. Hypothalamic Amenorrhea

Start date: March 2006
Phase:
Study type: Observational

The purpose of this study is to determine whether the hormone dynamics in women with anorexia nervosa and hypothalamic amenorrhea is related to bone loss in those populations.