Is NCT05819853 recruiting in Aurora, CO?

Yes, NCT05819853 is currently recruiting participants at its Aurora, CO location. This pcos (polycystic ovary syndrome) of bilateral ovaries clinical trial is actively enrolling qualified participants.

Is participation in this Aurora clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

PCOS (Polycystic Ovary Syndrome) of Bilateral Ovaries Clinical Trial in Aurora, CO

Q: How do I join the pcos (polycystic ovary syndrome) of bilateral ovaries clinical trial in Aurora?

To join this clinical trial in Aurora, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

About This PCOS (Polycystic Ovary Syndrome) of Bilateral Ovaries Study in Aurora

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.

Sponsor: University of Colorado, Denver

Who Can Participate

Inclusion Criteria

Ages 12-35 years

Sedentary- less than 2 hours of moderate (jogging, swimming etc.) exercise a week.

Oligomenorrhea, on or off metformin, as defined per age category in the most recent 2018 PCOS international guidelines

Initial BMI based on age and weight:

If \<18 years, initial BMI percentile ≥95

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

Must be weight stable within ±5kg in the 3 months prior to enrollment

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

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.

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

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

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.

Weight loss medications in the last 6 months

Currently pregnant or breastfeeding women. Development of pregnancy during the study period will necessitate withdrawal from the study.

Severe illness requiring hospitalization within 60 days.

Diabetes, defined as Hemoglobin A1C ≥6.5%

Anemia, defined as Hemoglobin \< 12 mg/dL

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.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Aurora?

Yes, this clinical trial (NCT05819853) has an active research site in Aurora, CO that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

PCOS (Polycystic Ovary Syndrome) of Bilateral Ovaries Treatment Options in Aurora, CO

If you're searching for pcos (polycystic ovary syndrome) of bilateral ovaries treatment options in Aurora, CO, this clinical trial (NCT05819853) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Aurora research site is actively enrolling participants for this phase 3 clinical trial. You'll receive care from experienced pcos (polycystic ovary syndrome) of bilateral ovaries specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all pcos (polycystic ovary syndrome) of bilateral ovaries clinical trials near you to find additional studies recruiting in your area.

PCOS (Polycystic Ovary Syndrome) of Bilateral Ovaries Clinical Trial in Aurora, CO

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