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Menopause, Premature clinical trials

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NCT ID: NCT02696889 Completed - Clinical trials for Premature Ovarian Failure

Rejuvenation of Premature Ovarian Failure With Stem Cells

ROSE-1
Start date: February 6, 2016
Phase: N/A
Study type: Interventional

The ROSE-1 study is designed to determine the efficacy of bone marrow derived stem cell therapy on ovarian function recovery in subjects with idiopathic and other types of premature or primary ovarian failure (POF or POI) and low ovarian reserves.

NCT ID: NCT02644447 Completed - Clinical trials for Premature Ovarian Failure

Transplantation of HUC-MSCs With Injectable Collagen Scaffold for POF

Start date: October 2015
Phase: Phase 1/Phase 2
Study type: Interventional

Cellular therapies are rapidly progressing fields and have shown immense promise in the treatment of damaged ovarian function. The purpose of this study is to determine safety and efficacy of intra-ovarian injection of allogeneic HUC-MSCs with injectable collagen scaffold in women with Premature Ovarian Failure (POF) and to study the preliminary efficacy of HUC-MSCs with injectable collagen scaffold injection on ovarian function improvement.

NCT ID: NCT02616510 Completed - Clinical trials for Cardiovascular Diseases

Primary Ovarian Insufficiency, Polycystic Ovary Syndrome & the CardiOvascular Risk Profile

POPCORn
Start date: July 2013
Phase:
Study type: Observational

The polycystic ovary syndrome (PCOS) is the most common endocrinopathy amongst women of reproductive age. PCOS is associated with various cardiovascular risk factors such as obesity, glucose intolerance, dyslipidemia hypertension and the metabolic syndrome. Whether these increased cardiovascular risk factors result in the development of actual cardiovascular disease in later life remains to be established. Women with premature ovarian insufficiency (POI), experience menopause prior to the age of 40 years. Women with POI may exhibit dyslipidemia. A young age at menopause has been previously associated with increased cardiovascular morbidity and mortality.

NCT ID: NCT02372474 Completed - Clinical trials for Premature Ovarian Failure

"It is a Real" The First Baby Of Autologous Stem Cell Therapy in Premature Ovarian Failure

Start date: March 2012
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this work is to evaluate the therapeutic potential of Autologous Mesenchymal sc (MSC) therapy in women suffering from POF.

NCT ID: NCT02151890 Completed - Clinical trials for Premature Ovarian Failure

Pregnancy After Stem Cell Transplantation in Premature Ovarian Failure

POF
Start date: March 2012
Phase: Phase 1/Phase 2
Study type: Interventional

Out of 112 high risk patients for Premature Ovarian Failure (POF), diagnosis was established in 10 cases. ESS cut off point for menstruation and pregnancy was 6.

NCT ID: NCT01177891 Completed - Clinical trials for Familial Premature Ovarian Failure

Genetic Analysis of Familial Cases of Premature Ovarian Failure

FAMIOP
Start date: October 2010
Phase: N/A
Study type: Observational

The Premature ovarian failure (POF) is a rare syndrome observed in women under 40 who induced estrogen deficiency and often leads to infertility final. The etiologies of POF remain unknown in more than 85% of cases. There are 5-10 % of familial cases.The main objective of this study is to recruit, phenotype and genotype 20 families with at least two subjects with nonsyndromic POF in order to identify new loci using a single technical standard nucleotide polymorphisms (SNPs). This study will also include related population and population control.

NCT ID: NCT01141972 Completed - Obesity Clinical Trials

The Role of Vitamin D in Menopause: Relationship to Menopausal Symptoms in Body Composition

FLASH
Start date: September 2010
Phase: Phase 1
Study type: Interventional

Specific Aim 1: To compare effects of Vitamin D supplementation to usual care on symptoms in women transitioning to early postmenopause and determine the associated effect size in order to conduct a power analysis for a future RCT. Hypothesis: Vitamin D insufficient women in early postmenopause who are randomized to supplementation, titrated to achieve sufficiency for 2 months, will have fewer symptoms including hot flashes, mood, and musculoskeletal complaints than women randomized to usual care. Specific Aim 2: To compare effects of Vitamin D supplementation to usual care on body composition (by dual-energy x-ray absorptiometry [DXA] and by weight, BMI, waist to hip ratio) in overweight/obese women transitioning to early postmenopause and determine the associated effect size for a power analysis for a future RCT. Hypothesis: Vitamin D insufficient women in the menopausal transition randomized to supplementation, titrated to achieve sufficiency for 9 months, will improve DXA body composition (less total body and abdominal fat), compared to women in usual care, who will have increased body weight, including total and abdominal fat. Specific Aim 3: To estimate the proportion of overweight/obese middle-aged women who achieve sufficiency by 1 month versus 2 or more months and to determine if achieving sufficiency by 1 month varies by baseline characteristics. Hypothesis: About 80% of participants will achieve sufficient Vitamin D level by 1 month. Those who need more than 1 month for sufficiency will have lower baseline levels and higher initial BMI.

NCT ID: NCT00837616 Completed - Hypogonadism Clinical Trials

Estrogen Dosing in Turner Syndrome: Pharmacology and Metabolism

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

Estrogen is necessary for feminization during puberty and to decrease bone resorption, the latter critical for the achievement of peak bone mass and normal bone health in the female. The practicing pediatric endocrinologist often faces the dilemma of how to best feminize girls with hypogonadism (lack of estrogen), manifested as delayed or arrested puberty, due to disorders of the brain or the ovaries. We propose a series of studies to address which type, dose, and route of delivery of estrogen are suitable choices in feminizing and sustaining estrogen concentrations in adolescent girls with Turner syndrome. To accomplish this we will study girls/young woman between the ages of 13 to 20 with Turner Syndrome in 2 protocols. In Protocol # 1 we will study 24 girls with TS, they will receive 3 different estrogen preparations, either by mouth or via a patch for a total of 6 weeks. They will come to the clinical research center for blood draws after 2 wks of taking the estrogen. With this study, we hope to learn how the body responds to estrogen differently, depending on the form estrogen is given and how high, estrogen levels gets in the blood in these girls with Turner Syndrome. We will be comparing these patients estrogen levels to girls that menstruate normally and do not have Turner Syndrome. In Protocol #2, 40 patients with TS will be recruited; these patients will take estrogen for 1 year, either by mouth or via a patch. Patients will come to the lab for blood drawn in 7 occasions and we will measure estrogen levels as well as other hormones and lipid levels. We will also perform a Dual-energy X-ray absorptiometry (DXA) study (like an X ray) to assess body composition and bone mineralization. We will adjust doses based on the estrogen levels we find. With this study we hope to learn how estrogen affects body composition, i.e., the amount of fat vs. muscle, and how different forms of estrogen affect blood cholesterol and other hormones. This study will allow us to understand better how to best replace young woman with Turner Syndrome with estrogen.

NCT ID: NCT00732693 Completed - Clinical trials for Premature Ovarian Failure

Evaluation of Physiologic and Standard Sex Steroid Replacement Regimens in Women With Premature Ovarian Failure

Start date: February 2002
Phase: Phase 4
Study type: Interventional

The aim of the study is to determine whether physiological sex steroid replacement improves parameters of skeletal, cardiovascular and reproductive health of women treated with current sex steroid replacement regimens.

NCT ID: NCT00471731 Completed - Menopause Clinical Trials

Dry Eye in Women With Turner Syndrome and Women With Premature Ovarian Failure

Start date: May 7, 2007
Phase: N/A
Study type: Observational

Premature ovarian failure (POF) is known to be associated with an increased risk of ocular surface disease (dry eye), likely due to the reduction of both estrogens and androgens seen in this condition. From preliminary data, we suspect that women with Turners syndrome (45, XO), a genetic abnormality that affects sex hormone levels, are also at increased risk of ocular surface disease. Comparing POF and TS women may allow us to distinguish different mechanisms for ocular surface disease, due to the different etiologies of hormonal (estrogen and androgen) alterations posed by POF and TS.