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

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.

Conditions

PCOS (Polycystic Ovary Syndrome) of Bilateral Ovaries, Obese

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
PCOS (Polycystic Ovary Syndrome) of Bilateral Ovaries
Intervention / Treatment

-

Contacts and Locations

Aurora

University of Colorado Anschutz/Children's Hospital Colorado Aurora, Aurora, Colorado, United States, 80045

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.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 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.

Ages Eligible for Study

12 Years to 35 Years

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of Colorado, Denver,

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

Study Record Dates

2028-06-30