GLP-1 medication effects on reproductive hormones in obese teenage girls with PCOS
Effects of Glucagon-like Peptide-1 (GLP-1) Agonist in Neuro-reproductive Function in Obese Adolescent Females With Polycystic Ovary Syndrome (PCOS)
We will test whether GLP-1 medications are linked to changes in reproductive hormones and menstrual cycles in obese adolescent girls with PCOS.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 20 (estimated) |
| Ages | 12 Years to 18 Years |
| Sex | Female |
| Sponsor | Nemours Children's Clinic Academic / other |
| Locations | 1 site (Jacksonville, Florida) |
| Trial ID | NCT07169136 on ClinicalTrials.gov |
What this trial studies
This observational study will enroll obese adolescent females with PCOS to examine relationships between GLP-1 receptor agonist exposure and neuro-reproductive function. Researchers will collect clinical histories, menstrual cycle data, metabolic measures, and blood samples to measure gonadotropin and sex steroid levels and to characterize GnRH/gonadotropin pulsatility. The study will also examine insulin and other metabolic markers and compare hormonal patterns in participants with and without GLP-1 agonist exposure. Work will be conducted at Nemours Children’s Clinic in Jacksonville and focuses on adolescents at least two years post-menarche who remain symptomatic despite lifestyle changes.
Who should consider this trial
Good fit: Obese (≥95th percentile) female adolescents aged 12–18 years, at least two years post-menarche, diagnosed with PCOS by NIH criteria and still symptomatic despite lifestyle modifications are ideal candidates.
Not a fit: Patients with diabetes or impaired glucose tolerance, abnormal thyroid function, non-classic congenital adrenal hyperplasia, hyperprolactinemia, a personal or family history of medullary thyroid carcinoma/MEN2, pancreatitis, or recent use of metformin, GLP-1 agonists, hormonal contraception, progesterone, or other insulin sensitizers are unlikely to be eligible or to gain benefit from this observational analysis.
Why it matters
Potential benefit: If successful, this could point to GLP-1–based approaches that improve menstrual regularity and reproductive hormone balance in obese adolescents with PCOS.
How similar studies have performed: GLP-1 receptor agonists are proven for diabetes and weight loss and some adult studies show metabolic and reproductive improvements, but direct effects on neuro-reproductive function in adolescents with PCOS remain under-studied.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Diagnosed with PCOS, by NIH criteria: oligomenorrhea (menstrual cycles \<21 or \>35 days) and hyperandrogenism (testosterone level or free androgen index (FAI) \> refence range for tanner stage) and in good overall health * Obesity (equal to or more than the 95th percentile) * Females ages 12 to 18 years, at least 2 years post-menarche * Participants has persistent symptoms of PCOS and obesity despite lifestyle modifications for at least 4 months. Exclusion Criteria: * Has abnormal thyroid function tests at Screening. * Has suspected or known Diabetes mellitus, impaired fasting glucose, or elevated hemoglobin A1c. * Has non-classic congenital adrenal hyperplasia. * Has hyperprolactinemia. * Has a known history or family history of medullary thyroid carcinoma or MEN2 and history of pancreatitis * Participants receiving prior treatment with metformin, GLP-1 agonists, oral contraception pills, progesterone, or other insulin sensitizers for at least 6 weeks prior to Screening. * Is currently pregnant or has been pregnant.
Where this trial is running
Jacksonville, Florida
- Nemours Children's Clinic — Jacksonville, Florida, United States (Recruiting)
Study contacts
- Study coordinator: Camila Pereira-Eshraghi, MD. MS.
- Email: camila.pereira-eshraghi@nemours.org
- Phone: 1 + 904-408-7895
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.