Symptoms and General Pathology

All Conditions

Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Syndrome

Polycystic Ovary Syndrome

Cysts

Ovarian Cysts

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Gonadal Disorders

Endocrine System Diseases

Hypoglycemic Agents

All Drugs and Chemicals

Gastrointestinal Agents

Semaglutide

Glucagon

Glucagon-Like Peptide-1 Receptor Agonists

Glucagon-Like Peptide 1

Bethany Brauer

Colette N Ndjom

Bethany N Brauer

The purpose of this study is to investigate the effect of semaglutide in women with Polycystic Ovarian Syndrome(PCOS ) and determine potential therapeutic benefits.

The study mainly focused for the following objectives:

To determine the effect of semaglutide on ovulation and menstrual regularity. To determine the effect of semaglutide on androgen levels, namely testosterone, sex hormone binding globulin, and changes in hirsutism.

To determine changes in weight, body mass index (BMI), and Glycated Hemoglobin( HbA1c) with semaglutide therapy.

Semaglutide and Polycystic Ovarian Syndrome: an Emerging Treatment Strategy

To access the weight changes during therapy

To access the ability to do exercise during the therapy

Methodist Health System

Nutritional and Metabolic Diseases

Obesity

Metformin

Participants with PCOS who are currently on metformin and still not having regular menses, will receive 10-months of semaglutide intervention

Participants with PCOS who are not on metformin or hormonal therapy, will receive 10-months of semaglutide intervention

10 months of semaglutide, with dose escalation as recommended by manufacturer. Maximum dose used will be 1.7mg

Wegovy Injectable Product

Participants already on Metformin as part of their clinical care, and still having irregular periods will be enrolled in the Metformin and Semaglutide arm. Semaglutide will be added in addition to the Metformin they are currently taking. 10 months of semaglutide, with dose escalation as recommended by manufacturer. Maximum dose used will be 1.7mg

Metformin and Wegovy

Yesenia Garcia-Reyes, MS

Yesenia Garcia Reyes

Melanie Cree-Green, MD,PhD

Girls and women 12-35 years old with obesity and polycystic ovarian syndrome who are on or off metformin, will receive a glucagon like peptide-1 receptor agonist intervention for 10 months to induce metabolic changes, weight loss and improve reproductive abnormalities.

Polycystic ovary syndrome is one of the most common endocrinopathies in women, presents with anovulation in adolescence, and reproductive dysfunction is related to excess weight. After a 4-month observation period of either no medication or metformin treatment, females aged 12-35 years with obesity and polycystic ovary syndrome will receive 10 months of a glucagon-like peptide-1 receptor agonist to induce metabolic changes, weight loss and improve reproductive abnormalities. We will assess the relationship between weight loss and reproductive function, as well as identify if age, hormonal and metabolic measures and such insulin sensitivity and insulin secretion predict the response to glucagon-like peptide-1 receptor agonist therapy.

PCOS is a condition only found in those of female sex

Role of Semaglutide in Restoring Ovulation in Youth and Adults With Polycystic Ovary Syndrome

Number of ovulations as assessed by urinary progesterone in 4 month before and during treatment

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

University of Colorado, Denver

Rare Diseases

Diabetes Mellitus

Diabetes Mellitus, Type 2

Carcinoma

Thyroid Neoplasms

Thyroid Diseases

Body Weight

Carcinoma, Neuroendocrine

Metabolic Diseases

Glucose Metabolism Disorders

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Endocrine Gland Neoplasms

Head and Neck Neoplasms

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Adenocarcinoma

Neoplasms, Nerve Tissue

Thyroid Cancer, Medullary

Neuroendocrine Tumor

Neuroepithelioma

Anti-Obesity Agents

Liraglutide

Dulaglutide

Exenatide

No treatment given

Annette Stemhagen, DrPH, FISPE

This study is conducted in the United States of America (USA). The aim of the study is to monitor the number of annual new adult cases of medullary thyroid carcinoma (MTC) and to establish a registry for these new cases in order to identify any possible increase related to the introduction of liraglutide, exenatide once-weekly, and other GLP-1 receptor agonists into the US market.

This active surveillance program will monitor for any signal indicating a possible association between treatment with long-acting GLP-1 RAs and the development of MTC in the United States population. Given the very low incidence of MTC in the general population, the expected rate of exposure to long-acting GLP-1 RAs, the anticipated long latency of the potential outcome under study and the limited data on underlying risk factors for development of MTC other than RET proto-oncogene mutations, an active surveillance program is the most efficient means of identifying a possible association between MTC and products in the long-acting GLP-1 RAs class. Given the uncertainty of the association of MTC in humans treated with these drugs, a study duration of at least fifteen years from the time of market introduction of the first long-acting GLP-1 RA was thought to provide evidence of an association, if one exists. If such an association is identified, a case-control study will be initiated to quantify the association.

The MTC registry is a Food and Drug Administration (FDA) post-marketing requirement for long-acting GLP-1 RA products. Because of the rarity of MTC and in order to minimize inconvenience to patients, physicians, and state cancer registries, FDA encouraged sponsors of long-acting GLP-1 RAs to work collaboratively to conduct this registry. Consequently, the MTC Registry Consortium has been formed for this purpose.

The MTC Registry Consortium refers to the Sponsors with approved long-acting GLP-1 RAs who have a contractual agreement to participate in the MTC Registry.

This active surveillance program for cases of MTC will be conducted with assistance from the North American Association of Central Cancer Registries (NAACCR). NAACCR is a collaborative umbrella organization for cancer registries, government agencies, professional organizations, and private groups in North America interested in improving the quality and use of cancer registry data. All of the central cancer registries in the U.S. and Canada are members of NAACCR, including those that participate in SEER.

An Active Surveillance Program for Cases of Medullary Thyroid Carcinoma (MTC)

Medullary Thyroid Carcinoma Surveillance Study: A Case-Series Registry

Currently this is undecided for this 15 year registry. The Data Monitoring Committee is a group of external interdisciplinary consultants who oversee the registry data to review if there are any signals or safety concerns with patients who have taken any of the long-acting GLP-1 RAs and were diagnosed with medullary thyroid carcinoma.

AstraZeneca

Eli Lilly and Company

United BioSource, LLC

Novo Nordisk A/S

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Semaglutide and Polycystic Ovarian Syndrome: an Emerging Treatment Strategy	NCT06222437	Polycystic Ovar...	Semaglutide	18 Years - 45 Years	Methodist Health System
Role of Semaglutide in Restoring Ovulation in Youth and Adults With Polycystic Ovary Syndrome	NCT05819853	PCOS (Polycysti... Obese	Wegovy Injectab... Metformin and W...	12 Years - 35 Years	University of Colorado, Denver
An Active Surveillance Program for Cases of Medullary Thyroid Carcinoma (MTC)	NCT01511393	Diabetes Diabetes Mellit... Medullary Thyro... Weight Manageme...	No treatment gi...	18 Years -	Novo Nordisk A/S

Spots Global Cancer Trial Database for semaglutide

Every month we try and update this database with for semaglutide cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for semaglutide

Every month we try and update this database with for semaglutide cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for semaglutide cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.