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Polycystic Ovary Syndrome clinical trials

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NCT ID: NCT00444288 Completed - Clinical trials for Polycystic Ovary Syndrome

PCOS Twin Study - Environmental Factors in the Development of Polycystic Ovary Syndrome, Phase 2

Start date: February 27, 2007
Phase: N/A
Study type: Observational

Polycystic Ovary Syndrome, or PCOS, is the most common endocrine disorder in women. Depending on the strictness of the diagnostic criteria used, it is thought to occur in about 6-10% of all women, many of whom do not know they have the syndrome. Women with PCOS produce abnormally high levels of male hormones (hyperandrogenism); this counteracts their ovaries' ability to make enough of the female hormones estrogen and progesterone needed for normal menstruation. PCOS is the number one cause of hormonally related infertility and also increases women's risks for diabetes, high blood pressure, hypercholesteremia, cardiovascular disease and certain cancers. It is currently unclear to what extent PCOS and PCOS-associated traits (hyperandrogenisms, hyperinsulinemia, insulin resistance, type 2 diabetes, dyslipidemia, hypertension, obesity, and coronary artery disease) are the results of environmental factors or genetic predisposition. Therefore, the NIEHS Program in Clinical Research is conducting a multi-phase twin study to measure the extent of PCOS heritability and to identify environmental and genetic factors involved in the development of PCOS. The proposal described here is for Phase 2 of this study. The goals of Phase 2 are to: 1) establish more reliable concordance rates and baseline heritability estimates for PCOS in MZ and DZ twins; and 2) establish a cohort of intact MZ and DZ female twin pairs as a resource for future studies. In Phase 1, about 1500 individual female twins were identified from the Mid-Atlantic Twin Registry (MATR) based on self report of a history of irregular periods and/or cystic ovaries in the MATR General Health Screening Questionnaire. Those twins were surveyed by phone for other traits associated with PCOS. In Phase 2, the twins most likely to have PCOS based on their answers to the Phase 1 phone survey will be recontacted for further PCOS screening. This includes providing a blood sample for measuring bioavailable testosterone (BaT) levels. Women with elevated BaT levels are likely to have PCOS. The women with elevated levels will then be asked to undergo a medical evaluation for PCOS confirmation. This includes a physical exam, medical history, ultrasound, 2-hour glucose tolerance and other biochemical blood tests, and a Ferriman-Gallwey evaluation for abnormal hirsutism (another characteristic of PCOS). The women will also be tested for pregnancy and zygosity. Their female co-twins will be invited to undergo...

NCT ID: NCT00442689 Completed - Metabolic Syndrome Clinical Trials

Metabolic Syndrome in PCOS: Precursors and Interventions

Start date: July 2006
Phase: N/A
Study type: Interventional

The purpose of this study is to investigate the metabolic effects of anti-androgens and oral contraceptive pills (OCPs), compared with placebo, in the treatment of women with PCOS. We hypothesized that controlling elevated androgen levels with either anti-androgens or OCPs would produce improvement in metabolic markers in PCOS women and would reduce their long term metabolic risk.

NCT ID: NCT00437333 Completed - Clinical trials for Polycystic Ovary Syndrome

Metformin Suspension and Insulin Sensitivity

Start date: December 2003
Phase: Phase 4
Study type: Interventional

Metformin is an insulin sensitizing drug routinely used for the treatment of anovulatory patients with polycystic ovary syndrome (PCOS). To date, the metabolic effects of the long-term metformin administration are know but no data are available on the effects after its suspension. The purpose of this study is to evaluate the effects of metformin suspension on insulin sensitivity in PCOS patients.

NCT ID: NCT00436865 Completed - Obesity Clinical Trials

Insulin and the Polycystic Ovary Syndrome--Weight Reduction Study

Start date: February 2007
Phase: N/A
Study type: Interventional

The polycystic ovary syndrome is the leading cause of female infertility in the United States. The disorder affects approximately 6-10% of women of reproductive age. It is widely accepted that "insulin resistance" may be responsible for the infertility of this syndrome. Women are insulin resistant when their bodies do not respond to insulin's action to handle sugar as they normally should. Because of this insulin resistance, women with the polycystic ovary syndrome are also at high risk for developing type 2 diabetes. We have previously shown that D-chiro-inositol (DCI), a substance naturally found in our body that helps insulin's action, is lacking in women with the polycystic ovary syndrome. Not having enough DCI may lead to insulin resistance. The purpose of this study is to determine if weight loss helps to replenish the body with DCI and help to promote insulin's action.

NCT ID: NCT00428311 Completed - Clinical trials for Polycystic Ovary Syndrome

Effects of Metformin vs Oral Contraceptives on CV Risk Markers in PCOS

Start date: April 2004
Phase: Phase 4
Study type: Interventional

Cardiovascular risk factors cluster in hyperandrogenic women - including those presenting with the polycystic ovary syndrome - in association with insulin resistance, obesity, and other metabolic disorders. The present clinical trial intends to compare the effects of oral contraceptives and metformin on PCOS patients, focusing on classic and non-classic cardiovascular risk markers and indexes of cardiovascular performance, in order to whether or not, as suspected by previous data obtained in non-hyperandrogenic women, oral contraceptives worsen the cardiovascular risk profile of PCOS women, favoring the use of metformin if the latter actually ameliorates such a risk.

NCT ID: NCT00427700 Completed - Clinical trials for Polycystic Ovary Syndrome

Induction of Ovulation With Raloxifene or Clomiphene Citrate in Polycystic Ovarian Syndrome

Start date: August 2008
Phase: Phase 3
Study type: Interventional

The Polycystic Ovarian Syndrome (PCOS) is a common disorder related to ovulation problems. Clomiphene citrate (CC) is the drug of first choice for this condition. Nevertheless, CC has a detrimental effect over uterine receptivity. Raloxifene is a Selective Estrogen Receptor Modulator, that does not have a detrimental effect over the endometrium, and also increase the serum levels of FSH, thus, inducting ovulation. The objective of this study is to compare the ovulation rate in PCOS patients between clomiphene citrate and raloxifene in a double blind randomized trial.

NCT ID: NCT00413179 Completed - Infertility Clinical Trials

The Effect of Metformin Added to Clomiphene Citrate on Pregnancy Rates in Hyperandrogenic, Chronic Oligoovulatory or Anovulatory Women

Start date: December 1997
Phase: Phase 3
Study type: Interventional

The purpose of our study was to conduct a placebo controlled, double-blind randomized trial in chronic oligoovulatory or anovulatory , hyperandrogenic, infertility patients comparing the effects of adjuvant metformin plus clomiphene citrate to clomiphene citrate plus placebo on pregnancy rates and ovulation rates. We hypothesized that combining metformin with clomiphene citrate would result in higher ovulation and pregnancy rates in hyperandrogenic women who have chronic oligoovulation or anovulation as the sole etiology for their infertility and who have unknown responsiveness to clomiphene citrate.

NCT ID: NCT00365638 Completed - Clinical trials for Polycystic Ovary Syndrome

Simvastatin Therapy in Women With Polycystic Ovary Syndrome.

Start date: April 2004
Phase: N/A
Study type: Interventional

The purpose of this study is to determine whether statins (simvastatin) improve clinical (excessive hair, skin problems), endocrine (androgens) and metabolic (lipids, markers of systemic inflammation) in women with polycystic ovary syndrome (PCOS).

NCT ID: NCT00364949 Completed - Clinical trials for Polycystic Ovary Syndrome

Intrauterine Environment in Polycystic Ovary Syndrome (PCOS) Probands

Start date: January 2003
Phase: N/A
Study type: Observational

Polycystic ovary syndrome (PCOS) is among the most common endocrine disorders in premenopausal women, affecting 7-10% of this population. This syndrome is characterized by elevated levels of testosterone and chronic anovulation, and frequently of obesity. This study is designed to test the hypothesis that there is in utero testosterone excess, altered insulin secretion, and/or intrauterine growth retardation in the female offspring of women with PCOS. The allele 8 can be used to identify the reproductive and metabolic abnormalities associated with PCOS. This study will determine whether allele 8 positive [A8(+)] female offspring have more profound changes in these parameters compared to A8(-) female offspring. Androgen and insulin levels in amniotic fluid from pregnant women with PCOS will be compared to levels in pregnant control women. Androgen and insulin levels in cord blood will also be measured. Further, gestational age and anthropomorphic measurements in offspring of women with PCOS will be assessed and compared to that in offspring of matched control women. We will test the hypothesis that androgens are elevated in infancy in the female offspring of women with PCOS. We will assess sex steroids, insulin, and c-peptide levels in infants of PCOS women and compare them to the levels in infants of control women up to 1 year of age during the minipuberty of infancy. We will determine whether any of these parameters differ in A8(+) compared to A8(-) PCOS offspring.

NCT ID: NCT00344851 Completed - Clinical trials for Polycystic Ovary Syndrome

Exenatide and Metformin Therapy in Overweight Women With PCOS

Start date: June 2006
Phase: Phase 2
Study type: Interventional

Current research has shown that the use of diabetes management practices aimed at reducing insulin resistance and hyperinsulinemia (such as weight reduction and the administration of oral antidiabetic drugs) in women with PCOS can not only improve glucose and lipid metabolism but can also reverse testosterone abnormalities and restore menstrual cycles. A new medicine called exenatide (Byetta) has been found to reduce body weight, as well as, improve abnormal glucose metabolism in diabetics. This randomized study will compare Exenatide (Byetta) to extended release metformin (Fortamet) to combination therapy (both Byetta and Fortamet) on menstrual cyclicity, hormone profiles and metabolic profiles over a 24-week period in women with PCOS.