RECRUITING

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

Conditions

PCOS (Polycystic Ovary Syndrome) of Bilateral Ovaries Obese PCOS semaglutide

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2023-11-03

Study Completion:2028-06-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05819853

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:12 Years to 35 Years

Sexes Eligible for Study:FEMALE

Accepts Healthy Volunteers:No

Standard Ages:CHILD, ADULT

Inclusion Criteria	Exclusion Criteria
Age 18 years or older Willing and able to provide informed consent Able to understand and follow study procedures Stable medical condition	1. Diagnosed with or have a family history of medullary thyroid carcinoma (MTC) or Multiple Endocrine Neoplasia syndrome type 2 (MEN2). Family history of medullary thyroid cancer or thyroid nodule palpated by endocrinologist at screening. - Per approved drug label 2. Use of medications known to affect insulin sensitivity: metformin (cannot have been used in the 3 months prior to screening for the untreated arm of the study), chronic oral steroids, oral glucocorticoids within 10 days, atypical antipsychotics, immunosuppressant agents, HIV medications, estrogen-containing hormonal contraception (cannot have been used in the 6 months prior to screening), progesterone-containing hormonal contraception (cannot have been used in the 3 months prior to screening). Dermal patch or vaginal ring contraception methods. Weight loss medications or stimulants. Use of other products containing other GLP-1 agonists. 3. Weight loss medications in the last 6 months 4. Currently pregnant or breastfeeding women. Development of pregnancy during the study period will necessitate withdrawal from the study. 5. Severe illness requiring hospitalization within 60 days. 6. Diabetes, defined as Hemoglobin A1C ≥6.5% 7. Anemia, defined as Hemoglobin \< 12 mg/dL 8. Diagnosed major psychiatric or developmental disorder limiting informed consent.

Inclusion Criteria

Exclusion Criteria

Age 18 years or older
Willing and able to provide informed consent
Able to understand and follow study procedures
Stable medical condition

1. Diagnosed with or have a family history of medullary thyroid carcinoma (MTC) or Multiple Endocrine Neoplasia syndrome type 2 (MEN2). Family history of medullary thyroid cancer or thyroid nodule palpated by endocrinologist at screening. - Per approved drug label
2. Use of medications known to affect insulin sensitivity: metformin (cannot have been used in the 3 months prior to screening for the untreated arm of the study), chronic oral steroids, oral glucocorticoids within 10 days, atypical antipsychotics, immunosuppressant agents, HIV medications, estrogen-containing hormonal contraception (cannot have been used in the 6 months prior to screening), progesterone-containing hormonal contraception (cannot have been used in the 3 months prior to screening). Dermal patch or vaginal ring contraception methods. Weight loss medications or stimulants. Use of other products containing other GLP-1 agonists.
3. Weight loss medications in the last 6 months
4. Currently pregnant or breastfeeding women. Development of pregnancy during the study period will necessitate withdrawal from the study.
5. Severe illness requiring hospitalization within 60 days.
6. Diabetes, defined as Hemoglobin A1C ≥6.5%
7. Anemia, defined as Hemoglobin \< 12 mg/dL
8. Diagnosed major psychiatric or developmental disorder limiting informed consent.

Contacts and Locations

Study Contact

Yesenia Garcia-Reyes, MS

CONTACT

720-777-6984

PCOSresearch@cuanschutz.edu

Principal Investigator

Melanie Cree-Green, MD,PhD

PRINCIPAL_INVESTIGATOR

University of Colorado Anschutz/Children's Hospital Colorado

Study Locations (Sites)

University of Colorado Anschutz/Children's Hospital Colorado Aurora

Aurora, Colorado, 80045

United States

Collaborators and Investigators

Sponsor: University of Colorado, Denver

Melanie Cree-Green, MD,PhD, PRINCIPAL_INVESTIGATOR, University of Colorado Anschutz/Children's Hospital Colorado

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-11-03

Study Completion Date2028-06-30

Study Record Updates

Study Start Date2023-11-03

Study Completion Date2028-06-30

Terms related to this study

Keywords Provided by Researchers

PCOS
semaglutide

Additional Relevant MeSH Terms

PCOS (Polycystic Ovary Syndrome) of Bilateral Ovaries
Obese