Role of Semaglutide in Restoring Ovulation in Youth and Adults With Polycystic Ovary Syndrome
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 12 Years to 35 Years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests whether semaglutide can help girls and women ages 12–35 with obesity and polycystic ovary syndrome (PCOS) release eggs more regularly. Participants will take the medicine for 10 months to study its effects on weight, how the body uses energy, and reproductive health. People taking or not taking metformin may qualify.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Female and 12–35 years old.
- Do less than 2 hours of moderate exercise, such as jogging or swimming, each week.
- Have PCOS with high testosterone levels and infrequent periods. For teens, this means infrequent periods more than 2 years after their first period, or no first period after age 15.
- Meet body mass index (BMI), a weight-for-height measure, rules: under 18, BMI at or above the 95th percentile; ages 18–35, BMI of at least 30, or at least 27 with a weight-related problem such as high blood pressure.
- Weight has stayed within about 11 pounds (5 kg) over the past 3 months.
- Do not use hormonal birth control. Avoid sex that could cause pregnancy, or use a copper IUD or two barrier birth control methods throughout the study.
- If taking semaglutide, avoid pregnancy for at least 2 months after stopping it.
- For the metformin-plus-semaglutide group, have taken a steady dose of at least 1,500 mg of metformin daily for at least 3 months before screening.
Who can't join
- Have a personal or family history of medullary thyroid cancer or MEN2, a condition that causes tumors in hormone-making glands; or have a thyroid lump found at screening.
- Use medicines the study does not allow, including certain steroids, mental health medicines, immune-suppressing medicines, HIV medicines, stimulants, or other GLP-1 medicines. Timing limits also apply to metformin, hormonal birth control, and weight-loss medicines.
- Are pregnant or breastfeeding, want to become pregnant in the next 12–18 months, or cannot follow the study’s birth control rules. Becoming pregnant means leaving the study.
- Had a severe illness needing a hospital stay within 60 days; have diabetes with an A1C blood sugar test of at least 6.5%; or have anemia, meaning low hemoglobin in the blood.
- Have liver disease other than nonalcoholic fatty liver disease, high liver blood tests, kidney disease, or low kidney function. A history of pancreas swelling, gallstones, or severe stomach or bowel disease also excludes you.
- Have untreated thyroid disease, an allergy to semaglutide, or another cause of high male-type hormones or missing periods.
- Have a major mental health or developmental condition that limits your ability to give informed consent, or have active symptoms of or treatment for anorexia or a bingeing/purging disorder.
- Have had weight-loss surgery, use THC more than 3 days a week, or drink more than 2 alcoholic drinks on more than 3 days a week.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
Inclusion Criteria 1. Female 2. Ages 12-35 years 3. Sedentary- less than 2 hours of moderate (jogging, swimming etc.) exercise a week. 4. Oligomenorrhea, on or off metformin, as defined per age category in the most recent 2018 PCOS international guidelines 5. Initial BMI based on age and weight: 1. If \<18 years, initial BMI percentile ≥95 2. If 18-35 years, initial BMI ≥30 kg/m2 OR initial BMI ≥27 kg/m2 with at least one weight-related comorbid condition, e.g., hypertension or dyslipidemia 3. Must be weight stable within ±5kg in the 3 months prior to enrollment 6. Diagnosed with PCOS per the most stringent NIH criteria with adaptation for adolescents (oligomenorrhea \>24 months post-menarche or primary amenorrhea after age 15 years and clinical/ biochemical hypertestosteronemia 7. Participants cannot be on hormonal contraception, so participants should remain abstinent or use reliable non-hormonal contraception (e.g., copper IUD) for the entire study period. For participants who receive semaglutide, they should avoid pregnancy for at least 2 months after stopping medication to avoid fetal exposure to the medication. 8. For participants in the metformin + semaglutide group, participants must have been stable on ≥ 1500 mg of metformin a day for at least 3 months by time of screening Exclusion 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. 10\) Known liver disease other than NAFLD, or AST or ALT \>125 IU/L. 11) Personal history of pancreatitis 12) Known renal disease of any severity or an eGFR at screening of \<45ml/min/1.73m2 13) History of severe GI disease (e.g., gastroparesis) 14) History of gallstones 15) Untreated thyroid disease 16) History of hypersensitivity to semaglutide 17) Other causes of hyperandrogenism (example: tumor, CAH) or amenorrhea (untreated thyroid disease, tumor, primary ovarian failure, prolactinoma). 18\) Active symptoms or undergoing treatment for anorexia nervosa or binging/purging disorder 19) Desiring pregnancy in the next 12-18 months. 20) Bariatric surgery 21) Use of THC (smoking or edible) more than 3 days a week 22) Alcohol use-drinking more than 2 drinks, more than 3 days a week 23) Any potential participants who cannot/will not commit to abstinence, use of a copper intrauterine device (IUD), or use of double barrier forms of contraception.
Study sites (1)
CO
- University of Colorado Anschutz/Children's Hospital Colorado Aurora · Aurora, CO 80045Yesenia Garcia Reyes · Study contact · 720-777-6984 · PCOSresearch@cuanschutz.eduMore trials in Aurora