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47 Polycystic Ovary Syndrome Trials Near You
Power is an online platform that helps thousands of Polycystic Ovary Syndrome patients discover FDA-reviewed trials every day. Every trial we feature meets safety and ethical standards, giving patients an easy way to discover promising new treatments in the research stage.
Learn More About PowerMetformin for Prediabetes
Cincinnati, Ohio
This trial is testing whether metformin can lower the risk of death, heart attacks, and strokes in people with pre-diabetes and heart or blood vessel issues. Metformin is a drug that helps control blood sugar levels and has been used to treat type 2 diabetes mellitus for more than 60 years. The study involves patients who have pre-diabetes and existing heart or blood vessel problems, aiming to see if metformin can provide additional health benefits.
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 4
Key Eligibility Criteria
Disqualifiers:Diabetes, Cirrhosis, Hypertension, Others
Must Not Be Taking:Metformin, Glucocorticoids, Cimetidine, Others
7410 Participants Needed
Ovarian Tissue Transplantation for Premature Ovarian Failure
Cleveland, Ohio
Premature ovarian failure, also known as primary ovarian insufficiency (POI), or premature menopause, affects 1-2% of women under 40. The diagnosis is typically made based on high levels of follicle stimulating hormone (FSH) and absent or irregular menstrual periods. It leads to infertility and menopause-like effects (hot flashes and thin bones) due to low estrogen levels. POI can result from various factors such as genetic conditions, autoimmune diseases, or previous medical treatments like chemotherapy.
Treatment of POI usually involves hormone replacement therapy and, if pregnancy is desired, assisted reproductive technologies such as in vitro fertilization (IVF) using an egg donor. However, IVF may not be an option for everyone due to personal, religious, ethical or financial reasons. Recent advances in medicine have identified ovarian tissue transplantation (OTT) as a potential solution. OTT involves transplanting either fresh or frozen ovarian tissue into the pelvic area, where it can begin functioning again. Studies in animals and humans have shown success in restoring hormonal function and even achieving pregnancies in some cases. Initial human trials of ovarian tissue transplants from another individual began with identical twins and have since expanded to include non-identical siblings with compatible tissue matches using immunosuppression. Success rates of OTT have been promising, with multiple live births reported between identical twins. Long-term studies indicate that transplanted tissue can remain functional for up to eight years. Ovarian tissue transplantation offers a promising avenue for women with POI to help restore fertility and hormonal function. Continued research and refinement of tissue techniques are essential to improve outcomes and expand access to this innovative treatment option.
This study will enroll 10 participants who will undergo ovarian tissue transplantation donated by a non-identical sister using an immunosuppression protocol at University Hospitals.
No Placebo Group
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Unphased
Age:21 - 40
Sex:Female
Key Eligibility Criteria
Disqualifiers:Hypertension, Diabetes, Heart Disease, Others
Must Be Taking:Immunosuppressive Medications
10 Participants Needed
DASH vs Low-Carb Diet for Polycystic Ovary Syndrome
Ann Arbor, Michigan
This trial is comparing two diets, the DASH diet and a very low-carbohydrate diet, to see which one better helps adults with polycystic ovary syndrome (PCOS) manage their blood sugar and weight. The DASH diet focuses on healthy foods to lower blood pressure, while the very low-carb diet cuts down on sugars to control blood sugar and weight.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Unphased
Age:21 - 45
Sex:Female
Key Eligibility Criteria
Disqualifiers:Type 1 Diabetes, Menopause, Pregnancy, Renal Disease, Others
Must Not Be Taking:Weight Loss Drugs, Psychostimulants, Corticosteroids, Warfarin
214 Participants Needed
Transvaginal Ablation for Polycystic Ovary Syndrome
Bloomfield Hills, Michigan
A Prospective, Multicenter, Randomized, Pivotal Study of the May Health System in Transvaginal Ablation of Ovarian Tissue under Ultrasound Guidance in Women with Infertility due to Polycystic Ovary Syndrome
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:18 - 40
Sex:Female
Key Eligibility Criteria
Disqualifiers:Pregnancy, BMI > 40, Hyperandrogenism, Poor Glycemic Control, Others
Must Not Be Taking:Anticoagulants, Ovulation Inducers
195 Participants Needed
Lifestyle Interventions for Chronic Disease
Lewisburg, West Virginia
Developed nations worldwide are currently enduring a health crisis, as chronic diseases continue to decrease quality of life and promote additional disease states or even death for much of the population. Rural populations are at a particular disadvantage, as they lack access to health clubs, wellness programs and similar resources that are more available in urban areas. Although pharmaceutical therapies have continued to show therapeutic advancements, the rates of disease onset and death from chronic disease has not seen similar improvements, and in fact continue to worsen. Excitingly, significant evidence has been published demonstrating an affordable, effective treatment to directly treat and prevent these chronic diseases, but few have demonstrated successful implementation of this therapy, which is improved lifestyle. Specifically, physical activity and healthy body composition are powerful therapeutics that have been demonstrated to effectively combat and prevent chronic diseases. Additionally, improving these lifestyle factors are often more effective than pharmaceutical interventions without the wide range of side effects. Unfortunately, barriers exist on multiple tiers in the practice of family medicine that demote the implementation of lifestyle medicine. To better serve patients at risk of, or suffering from chronic disease, the investigators are seeking to establish a lifestyle medicine prescription program for rural West Virginia. This program will provide patient education on the benefits of physical activity, body composition, and help patients identify strategies to implement healthy lifestyle choices that can be sustainable for the long-term. Patients will be advised on local opportunities to increase physical activity (yoga studio, martial arts, fitness facilities, aquatic center, etc.) and provided access to the facilities they are most likely to adhere to regularly. They will also be provided training on exercise techniques, equipment, and facilities to increase familiarity and comfort in these settings.
Stay on current meds
No Placebo Group
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Unphased
Age:18 - 64
Key Eligibility Criteria
Disqualifiers:No Chronic Disease, Others
95 Participants Needed
Hormone Therapy for Polycystic Ovary Syndrome
Charlottesville, Virginia
This trial is testing if flutamide, which blocks testosterone, can help women with PCOS improve their hormone regulation. The study aims to see if this medication can enhance the body's response to progesterone. Flutamide has been used to treat high levels of male hormones in women with PCOS, but its use is limited by potential liver damage and cost.
Trial Details
Trial Status:Recruiting
Trial Phase:Early Phase 1
Age:18 - 30
Sex:Female
Key Eligibility Criteria
Disqualifiers:Diabetes, Liver Abnormalities, Cancer, Others
Must Not Be Taking:Systemic Corticosteroids
10 Participants Needed
Metformin vs. Birth Control Pills for Polycystic Ovary Syndrome
Charlottesville, Virginia
The goal of this study is to determine the relative desirability of metformin vs. oral combined hormonal contraceptives (OCs) in treating Polycystic Ovary Syndrome (PCOS) in women of later reproductive age. Polycystic Ovary Syndrome Questionnaire (PCOSQ) score will be used as a proxy for patient satisfaction. In light of their respective effects on the classic and metabolic facets of PCOS, metformin will provide non-inferior patient satisfaction compared to OCs in later reproductive age women with PCOS.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Early Phase 1
Age:40 - 49
Sex:Female
Key Eligibility Criteria
Disqualifiers:Diabetes, Hypertension, Stroke, Others
Must Not Be Taking:Anticonvulsants, Rifampicin, Glucocorticoids, Others
88 Participants Needed
Predictors of Hyperandrogenism for Polycystic Ovary Syndrome
Charlottesville, Virginia
The objective of the study is to determine the relative contributions of four established predictors of hyperandrogenism (luteinizing hormone \[LH\] secretion, ovarian response to recombinant human chorionic gonadotropin \[r-hCG\] administration, adrenal response to adrenocorticotropic hormone \[ACTH\] administration, and hyperinsulinemia) in older vs. young women with Polycystic Ovary Syndrome (PCOS) in a cross-sectional, physiological study. The investigators hypothesize that hyperinsulinemia is a stronger independent predictor of free testosterone (T) in older reproductive aged (vs. young) women with PCOS.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Early Phase 1
Age:20 - 49
Sex:Female
Key Eligibility Criteria
Disqualifiers:Diabetes, Cushing's Syndrome, Others
Must Not Be Taking:Oral Contraceptives, Metformin
144 Participants Needed
Spironolactone for Hyperandrogenism in Pubertal Girls
Charlottesville, Virginia
The purpose of this study is to determine if, in mid- to late pubertal girls with hyperandrogenism (HA), androgen-receptor blockade (spironolactone) alone normalizes sleep-wake luteinizing hormone (LH) pulse frequency (primary endpoint) and overall LH and follicle-stimulating hormone secretion (secondary endpoints).
Trial Details
Trial Status:Recruiting
Trial Phase:Early Phase 1
Age:10 - 17
Sex:Female
Key Eligibility Criteria
Disqualifiers:Diabetes, Virilization, Cancer, Others
Must Be Taking:Spironolactone
32 Participants Needed
Estradiol for Polycystic Ovary Syndrome
Charlottesville, Virginia
The purpose of this study is to determine if estradiol augmentation of luteinizing hormone (LH) secretion secretion (primary endpoint) and follicle-stimulating hormone (FSH) secretion (secondary endpoint) is reduced in adult women with polycystic ovary syndrome.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Early Phase 1
Age:18 - 30
Sex:Female
Key Eligibility Criteria
Disqualifiers:Males, Pregnancy, Diabetes, Cancer, Others
37 Participants Needed
Hormone Regulation Therapy for Polycystic Ovary Syndrome
Charlottesville, Virginia
The purpose of this study is to determine if, in mid- to late pubertal girls with hyperandrogenism, androgen-receptor blockade (spironolactone) improves the ability of progesterone to acutely reduce waking luteinizing hormone pulse frequency (primary endpoint).
Trial Details
Trial Status:Recruiting
Trial Phase:Early Phase 1
Age:10 - 17
Sex:Female
Key Eligibility Criteria
Disqualifiers:Diabetes, Pregnancy, Cancer, Others
Must Be Taking:Spironolactone
32 Participants Needed
Dexamethasone + rhCG for Polycystic Ovary Syndrome
Charlottesville, Virginia
Women with polycystic ovary syndrome (PCOS) can have unwanted facial or male-patterned body hair, irregular menstrual periods, or no menstrual periods excess body weight, and infertility. It also results in elevated androgen levels such as testosterone. In women with PCOS, the majority of excess androgens are produced by the ovaries. However, it is unknown whether the ovaries are fully active during early puberty. The purpose of this study is to determine how the ovaries contribute to the production of male hormones in the body during different stages of puberty, so that it can be better understood why some females have excess androgens.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Unphased
Age:7 - 18
Sex:Female
Key Eligibility Criteria
Disqualifiers:Diabetes, Pregnancy, Genetic Syndromes, Others
Must Be Taking:Iron Supplements
80 Participants Needed
Time Restricted Eating for Polycystic Ovary Syndrome
Chicago, Illinois
Background: Polycystic ovary syndrome (PCOS) is the most common cause of anovulatory infertility among young women. This syndrome is a reproductive and endocrinological disorder that affects up to 18% of reproductive-aged women. To date, the only strategy shown to reverse PCOS is sustained weight loss of 5-10%. At present, daily calorie restriction (CR) is the main diet prescribed to patients with PCOS for weight loss. However, some women find it difficult to adhere to CR because calorie intake must be vigilantly monitored every day. Considering these problems with CR, another approach that limits timing of food intake, instead of number of calories consumed, has been developed. This diet is called "time restricted eating" (TRE) and involves confining the period of food intake to 6-8 h per day. TRE allows individuals to self-select foods and eat ad libitum during a large part of the day, which greatly increases compliance to these protocols. Recent findings show that TRE significantly reduces body weight, insulin resistance, and inflammation in adults with obesity. However, no randomized controlled trials have studied the role of TRE in treating PCOS.
Accordingly, this study will compare the effects of TRE vs CR in females with PCOS over 6 months on body weight, androgen markers, inflammatory markers and insulin sensitivity.
Methods: A 6-month randomized, controlled, parallel-arm trial will be implemented. Females with obesity and PCOS will be randomized to 1 of 3 groups: (1) 6-h TRE (ad libitum food intake from 1-7 pm, fasting from 7pm-1pm); (2) CR (25% energy restriction daily); or (3) control group (ad libitum intake with no meal timing restrictions).
No Placebo Group
Trial Details
Trial Status:Enrolling By Invitation
Age:18 - 40
Sex:Female
Key Eligibility Criteria
Disqualifiers:Not Listed
300 Participants Needed
Progesterone + Estradiol for Polycystic Ovary Syndrome
Charlottesville, Virginia
Girls with high levels of the male hormone testosterone often develop polycystic ovary syndrome (PCOS) as adults. Women with PCOS often have irregular menstrual periods, excess facial and body hair, and weight gain. Women with PCOS also have difficulty becoming pregnant. Some, girls with high levels of male hormone will develop normal hormone levels as they grow up. Most girls continue to have high levels of male hormone as adults. In addition, girls with elevated levels of male hormones often have lower fertility rates in adulthood. In this study the investigators will aim to discover the effect of 7 days of estrogen and progesterone on GnRH pulses in girls and women with the goal of understanding how and why some girls and women have higher levels of male hormone and the causes of PCOS. If investigators understand the causes of these disorders, they may be able to better treat them and perhaps even learn how to prevent the development of PCOS.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Unphased
Age:8 - 18
Sex:Female
Key Eligibility Criteria
Disqualifiers:Congenital Adrenal Hyperplasia, Cancer, Others
Must Not Be Taking:Hormonal Medications
60 Participants Needed
Mirabegron + B Complex Plus Vitamin C for Brown Adipose Tissue
Bethesda, Maryland
This trial tests if the drug mirabegron can increase brown fat activity in people aged 18-40 with different body types. The drug helps brown fat burn more energy, which might aid in weight loss and better sugar management.
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 1
Age:18 - 40
Key Eligibility Criteria
Disqualifiers:Diabetes, Hypertension, Cardiovascular Disease, Others
Must Be Taking:Mirabegron
100 Participants Needed
Time-Restricted Eating for Type 2 Diabetes
Toronto, Ontario
This study will evaluate the effectiveness of time-restricted eating (TRE), which is a form of intermittent fasting. When performing TRE, individuals consume all of their calories within a specific time window and then only consume water or other no calorie drinks the rest of the day. TRE is performed each day. There is no restriction on the quality or amount of food that people can consume during their eating window (ad libitum eating) with TRE, which can last anywhere from 4 to 12 hours. We are comparing three different 9-hour eating windows to determine whether the start and stop time of the eating window impact blood sugar control in individuals with obesity who also have or are at risk for type 2 diabetes. We also aim to determine if there are differences in the effects of the timing of eating window between males and females.
No Placebo Group
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Unphased
Key Eligibility Criteria
Disqualifiers:Bariatric Surgery, Cognitive Disorder, Others
Must Not Be Taking:Exogenous Insulin, Sulfonylureas, Antiobesity Medications
120 Participants Needed
Inositol for Polycystic Ovary Syndrome
Hershey, Pennsylvania
This trial tests if inositol, a dietary supplement, can reduce high hormone levels in women with PCOS. It aims to see if inositol can lower testosterone and improve symptoms by balancing hormone levels. Inositol has been shown to improve ovarian function and metabolic profiles in women with PCOS, with myo-inositol (MI) and D-chiro-inositol (DCI) being particularly effective.
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2
Age:18 - 45
Sex:Female
Key Eligibility Criteria
Disqualifiers:Hyperprolactinemia, Cushing's Syndrome, Others
Must Not Be Taking:Metformin, Hormonal Contraceptives
128 Participants Needed
Exercise Training for Aging
Durham, North Carolina
The primary purpose of this study is to assess the effects of aging on markers of physical reserve and exercise-induced adaptations in resilience in older adults who completed a structured exercise program within the last 15 years (Parent trial: STRRIDE-PD; NCT00962962). This feasibility pilot study will enroll up to 8 participants to complete a 6-month aerobic exercise intervention.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:60 - 90
Key Eligibility Criteria
Disqualifiers:Tobacco Use, Insulin-dependent Diabetes, Cardiovascular Disease, Others
Must Be Taking:Cardiometabolic Medications
8 Participants Needed
Zinc for Prediabetes
Lancaster, Pennsylvania
The purpose of this investigation is to evaluate the impact of zinc supplementation on fasting glucose levels, hemoglobin A1c (HbA1c), and other indices of glucose homeostasis in individuals with prediabetes. The investigators hypothesize that prediabetic subjects receiving zinc will demonstrate a greater decrease in HbA1c and blood glucose compared to prediabetic subjects receiving placebo.
Specific Aim: Conduct a prospective, double-blind randomized clinical trial comparing the effects of 12 months of zinc supplementation (zinc gluconate 30 milligram \[mg\] per day) versus placebo on glucose homeostasis. Based upon expected effect size and power calculations, and anticipating a 20% drop-out rate, the investigators will study 200 prediabetic subjects (100 per group) using a 1:1 randomization design. HbA1c, fasting plasma glucose, and other measures will be obtained at 0, 6, and 12 months and will be compared between zinc supplementation and placebo groups.
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 4
Key Eligibility Criteria
Disqualifiers:Pregnant, Cancer, Liver Disease, Others
Must Not Be Taking:Corticosteroids, Antipsychotics, Protease Inhibitors, Others
200 Participants Needed
Letrozole + Clomiphene Citrate for Anovulation
Madison, Wisconsin
This trial tests if combining letrozole and clomiphene citrate helps women with PCOS ovulate better than using letrozole alone. Letrozole lowers estrogen to stimulate egg release, and clomiphene citrate boosts hormone production for the same purpose. The study aims to see if this combination increases the chances of ovulation. Clomiphene citrate has been widely used for over 50 years as a first-line therapy for ovulation induction in PCOS, while letrozole is a newer alternative that appears to improve live birth rates compared to clomiphene.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 4
Age:18 - 40
Sex:Female
Key Eligibility Criteria
Disqualifiers:Pregnancy, Endometriosis, Diabetes, Hypertension, Others
Must Not Be Taking:Hormonal Contraception
190 Participants Needed
Why Other Patients Applied
"I was diagnosed with stage 4 pancreatic cancer three months ago, metastatic to my liver, and I have been receiving and responding well to chemotherapy. My blood work revealed that my tumor markers have gone from 2600 in the beginning to 173 as of now, even with the delay in treatment, they are not going up. CT Scans reveal they have been shrinking as well. However, chemo is seriously deteriorating my body. I have 4 more treatments to go in this 12 treatment cycle. I am just interested in learning about my other options, if any are available to me."
ID
Pancreatic Cancer PatientAge: 40
"I changed my diet in 2020 and I’ve lost 95 pounds from my highest weight (283). I am 5’3”, female, and now 188. I still have a 33 BMI. I've been doing research on alternative approaches to continue my progress, which brought me here to consider clinical trials."
WR
Obesity PatientAge: 58
"I've tried several different SSRIs over the past 23 years with no luck. Some of these new treatments seem interesting... haven't tried anything like them before. I really hope that one could work."
ZS
Depression PatientAge: 51
"As a healthy volunteer, I like to participate in as many trials as I'm able to. It's a good way to help research and earn money."
IZ
Healthy Volunteer PatientAge: 38
"I have dealt with voice and vocal fold issues related to paralysis for over 12 years. This problem has negatively impacted virtually every facet of my life. I am an otherwise healthy 48 year old married father of 3 living. My youngest daughter is 12 and has never heard my real voice. I am now having breathing issues related to the paralysis as well as trouble swallowing some liquids. In my research I have seen some recent trials focused on helping people like me."
AG
Paralysis PatientAge: 50
Vaginal Hormonal Contraception for PCOS
Philadelphia, Pennsylvania
A prospective study to determine the metabolic effects of the contraceptive vaginal ring among overweight and obese women with polycystic ovary syndrome (PCOS). We will recruit a total of 40 participants and study use of the vaginal ring over a 4-month period.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 4
Age:18 - 40
Sex:Female
Key Eligibility Criteria
Disqualifiers:Pregnancy, Metabolic Syndrome, Diabetes, Hypertension, Cancer, Others
Must Not Be Taking:Hormonal Contraception, Lipid-lowering Agents
28 Participants Needed
Oral Contraceptives + Resistant Starch for Polycystic Ovary Syndrome
Philadelphia, Pennsylvania
This study will enroll women with PCOS to study the effects of first line therapy, oral contraceptive pills, and then either 12 weeks of resistant starch or 12 weeks of placebo to explore if resistant starch improves cardiometabolic parameters or impacts gut dysbiosis compared to placebo.
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2
Age:18 - 40
Sex:Female
Key Eligibility Criteria
Disqualifiers:Diabetes, Liver Disease, Renal Disease, Others
Must Be Taking:Oral Contraceptives
100 Participants Needed
Insulin Management for Non-alcoholic Fatty Liver Disease
New York, New York
This is a single-center, prospective, randomized, controlled (crossover) clinical study designed to investigate the impact of lowering insulin levels on hepatic glucose production (HGP) vs de novo lipogenesis (DNL) in people with insulin resistance. The investigators will recruit participants with a history of overweight/obesity and evidence of insulin resistance (i.e., fasting hyperinsulinemia plus prediabetes and/or impaired fasting glucose and/or Homeostasis Model Assessment of Insulin Resistance \[HOMA-IR\] score \>=2.73), and with evidence of metabolic dysfunction-associated steatotic liver disease (MASLD). Participants will undergo two pancreatic clamp procedures -- one in which serum insulin levels are maintained near hyperinsulinemic baseline (Maintenance Hyperinsulinemia or "MH" Protocol) and the other in which serum insulin levels are lowered by 50% (Reduction toward Euinsulinemia or "RE" Protocol). In both clamps the investigators will use stable-isotope tracers to monitor hepatic glucose and triglyceride metabolism. The primary outcome will be the impact of steady-state clamp insulinemia on HGP vs DNL.
No Placebo Group
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Phase 1
Age:18 - 65
Key Eligibility Criteria
Disqualifiers:Diabetes, Cardiovascular Diseases, Liver Disease, Others
Must Not Be Taking:Antidiabetics, Antipsychotics, Antidepressants, Others
36 Participants Needed
Insulin Infusion for Non-alcoholic Fatty Liver Disease
New York, New York
This is a single-center, prospective, randomized, controlled (crossover) clinical study designed to investigate the specific dose-response impact of insulin infusion rate (IIR) on blood glucose levels during a pancreatic clamp study. The investigators will recruit participants with a history of overweight/obesity and evidence of insulin resistance (i.e., fasting hyperinsulinemia plus prediabetes and/or impaired fasting glucose and/or Homeostasis Model Assessment of Insulin Resistance \[HOMA-IR\] score \>=2.73), and with evidence of, or clinically judged to be at high risk for, uncomplicated non-alcoholic fatty liver disease (NAFLD). Participants will undergo two pancreatic clamp procedures in which individualized basal IIR are identified, followed in one by maintenance of basal IIR (maintenance hyperinsulinemia, MH) and in the other by a stepped decline in IIR (reduction toward euinsulinemia, RE). In both clamps the investigators will closely monitor plasma glucose and various metabolic parameters. The primary outcome will be the absolute and relative changes in steady-state plasma glucose levels at each stepped decline in IIR.
No Placebo Group
Trial Details
Trial Status:Recruiting
Age:18 - 65
Key Eligibility Criteria
Disqualifiers:Diabetes, Cardiovascular, Liver, Others
Must Not Be Taking:Antidiabetics, Corticosteroids, Opioids, Others
42 Participants Needed
Alpelisib for Insulin Resistance
New York, New York
The goal of this clinical trial is to understand how the blood sugar-lowering hormone insulin works in healthy adults versus those who are at risk for type 2 diabetes. The study will use a drug called alpelisib, which interferes with insulin's actions in the body, to answer the study's main question: does the liver continue to respond to insulin's stimulation of fat production even when it loses the ability to stop making glucose (sugar) in response to insulin. Researchers will compare the impact of single doses of both alpelisib and placebo (inert non-drug) in random order (like flipping a coin) in study participants. Participants will be asked to stay twice overnight in the hospital, take single doses of alpelisib and placebo (one or the other on each of the two hospital stays), and receive intravenous (into the vein) infusions of non-radioactive "tracer" molecules that allow researchers to measure the production of glucose (sugar) and fats by the liver. Measurements will be done both overnight, while participants are asleep and fasting (not eating or drinking other than water) and while consuming a standardized diet of nutritional beverages during the following day.
The objective is to evaluate the effect of lowering insulin levels, while maintaining constant mild hyperglycemia, on plasma glucose and lipid levels.
Prior Safety Data
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 1
Key Eligibility Criteria
Disqualifiers:Diabetes, Cardiovascular, Liver, Psychiatric, Others
Must Not Be Taking:Antidiabetics, Lipid-lowering, Antipsychotics, Corticosteroids
32 Participants Needed
Diazoxide for Non-alcoholic Fatty Liver Disease
New York, New York
The goal of this clinical trial is to compare a two-week course of diazoxide (at two different doses) and placebo in people with overweight/obesity and insulin resistance (IR) with, or at high risk for, non-alcoholic fatty liver disease (NAFLD). The main questions it aims to answer are how mitigation of compensatory hyperinsulinemia with diazoxide affects parameters of glucose and lipid metabolism (how people with IR and NAFLD respond to lowering high insulin levels so that the investigators can see what happens to how the liver handles fat and sugar).
Participants will:
* Take 27 doses of diazoxide (at 1 mg per kg of body weight per dose \[mpk\] or 2 mpk) or of placebo, over 14 days
* Take 32 doses of heavy (deuterated) water (50 mL each) over 14 days
* Have blood drawn and saliva collected after an overnight fast on four mornings over the two-week study period
* Consume their total calculated daily caloric needs as divided into three meals per day
* Wear a continuous glucose monitor for the two-week study period
Researchers will compare fasting blood tests at intervals during the study period in participants randomized (like the flip of a coin) to diazoxide 1 mpk, diazoxide 2 mpk, or placebo, to see how the drug treatment affects plasma glucose, serum insulin, and serum lipid parameters (triglycerides, free fatty acids, and apolipoprotein B). They will also consume heavy (deuterated) water to assess de novo lipogenesis (building of new fatty acids by the liver).
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 1
Key Eligibility Criteria
Disqualifiers:Diabetes, Cardiovascular Disease, Liver Disease, Others
Must Not Be Taking:Antidiabetics, Lipid-lowering, Vasodilators, Others
72 Participants Needed
Weight Loss Program for PCOS and Obesity
Ottawa, Ontario
The goal of this clinical trial is to study the effects of a intensive weight loss program (STREAM) in patients living with PCOS. The main questions the investigators aim to answer are: how much weight will these patients lose over a 24-week program, and what other health markers (ie., insulin sensitivity) will improve and by how much?
Participants will complete a 24-week weight loss program (STREAM). During this program they will:
* weigh themselves
* complete regular bloodwork and
* fill out a Quality of Life questionnaire at regular intervals
No Placebo Group
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Unphased
Sex:Female
Key Eligibility Criteria
Disqualifiers:Bariatric Surgery, Pregnancy, Others
Must Not Be Taking:OCP, IUD, Weight Drugs, Androgens
20 Participants Needed
Vitamin D for PCOS
New Haven, Connecticut
This study is a double blind, placebo controlled, randomized trial of study subjects with PCOS and low vitamin D to 2 groups- placebo and vitamin D replacement. Participants and investigators will be blinded to treatment modality until the end of the trial period
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:13 - 21
Sex:Female
Key Eligibility Criteria
Disqualifiers:Hyperandrogenism, Chronic Renal Diseases, Others
60 Participants Needed
Ketone Supplementation for Polycystic Ovary Syndrome
Montréal, Quebec
Polycystic ovary syndrome (PCOS) affects 1 in 5 females of reproductive age. Commonly characterized as a disorder of infertility, PCOS is often accompanied by 3 potent cardiovascular disease (CVD) risk factors: insulin resistance, endothelial dysfunction, and elevated blood pressure. Accordingly, PCOS is associated with the development of CVD, the second leading cause of death in females in Canada. However, effective treatments to improve cardiovascular health in PCOS are lacking.
Exogenous ketone monoester (KME) ingestion has been shown to improves outcomes associated with insulin resistance, endothelial function, and blood pressure regulation in healthy individuals and individuals predisposed to CVD. Therefore, oral ketone supplements offer a practical and effective strategy for improving cardiovascular health; however, this treatment has yet to be evaluated in PCOS.
Therefore, the overall goal of this project is to employ KME ingestion to improve markers of cardiovascular health in females with PCOS.
On two different days, participants will consume either a beverage containing a ketone supplement or a beverage containing a placebo supplement. The objectives are to compare responses between KME and placebo ingestion, and examine all outcomes related to cardiovascular health in females with PCOS in comparison with female controls of similar age and body mass index. The effects of KME ingestion will be quantified on: 1) glycemic control during an oral glucose tolerance test; 2) endothelial function using the flow-mediated dilation test; 3) blood pressure and acute blood pressure regulation; and 4) hemodynamic responses to acute exercise.
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:18 - 40
Key Eligibility Criteria
Disqualifiers:Smoking, Cardiometabolic Disease, Pregnancy, Others
Must Not Be Taking:Anti-hypertensives, Anti-androgens, Metformin
60 Participants Needed
Kisspeptin for Polycystic Ovary Syndrome
Boston, Massachusetts
This trial involves giving kisspeptin and another hormone to people with PCOS to see how it affects their hormone levels. The goal is to understand if kisspeptin can help regulate their reproductive hormones. Kisspeptin has recently emerged as a key regulator of the reproductive system in women and has been shown to stimulate the secretion of another important hormone.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 1
Age:18 - 45
Sex:Female
Key Eligibility Criteria
Disqualifiers:Excessive Alcohol, Illicit Drugs, Others
Must Not Be Taking:Hormonal Medications
4 Participants Needed
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Frequently Asked Questions
How much do Polycystic Ovary Syndrome clinical trials pay?
Each trial will compensate patients a different amount, but $50-100 for each visit is a fairly common range for Phase 2–4 trials (Phase 1 trials often pay substantially more). Further, most trials will cover the costs of a travel to-and-from the clinic.
How do Polycystic Ovary Syndrome clinical trials work?
After a researcher reviews your profile, they may choose to invite you in to a screening appointment, where they'll determine if you meet 100% of the eligibility requirements. If you do, you'll be sorted into one of the treatment groups, and receive your study drug. For some trials, there is a chance you'll receive a placebo. Across Polycystic Ovary Syndrome trials 30% of clinical trials have a placebo. Typically, you'll be required to check-in with the clinic every month or so. The average trial length for Polycystic Ovary Syndrome is 12 months.
How do I participate in a study as a "healthy volunteer"?
Not all studies recruit healthy volunteers: usually, Phase 1 studies do. Participating as a healthy volunteer means you will go to a research facility several times over a few days or weeks to receive a dose of either the test treatment or a "placebo," which is a harmless substance that helps researchers compare results. You will have routine tests during these visits, and you'll be compensated for your time and travel, with the number of appointments and details varying by study.
What does the "phase" of a clinical trial mean?
The phase of a trial reveals what stage the drug is in to get approval for a specific condition. Phase 1 trials are the trials to collect safety data in humans. Phase 2 trials are those where the drug has some data showing safety in humans, but where further human data is needed on drug effectiveness. Phase 3 trials are in the final step before approval. The drug already has data showing both safety and effectiveness. As a general rule, Phase 3 trials are more promising than Phase 2, and Phase 2 trials are more promising than phase 1.
Do I need to be insured to participate in a Polycystic Ovary Syndrome medical study?
Clinical trials are almost always free to participants, and so do not require insurance. The only exception here are trials focused on cancer, because only a small part of the typical treatment plan is actually experimental. For these cancer trials, participants typically need insurance to cover all the non-experimental components.
What are the newest Polycystic Ovary Syndrome clinical trials?
Most recently, we added Vitamin D for PCOS, Heat Therapy for Prediabetes and Oral Contraceptives + Resistant Starch for Polycystic Ovary Syndrome to the Power online platform.
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