Clinical trial for PCOS (Polycystic Ovary Syndrome) of Bilateral Ovaries
Official title Role of Semaglutide in Restoring Ovulation in Youth and Adults With Polycystic Ovary Syndrome
ClinicalTrials.gov ID: NCT05819853
What this study is testing
What is Semaglutide Injectable Product (Wegovy and/or Ozempic)?
This is an investigational injectable medicine being studied to help with weight loss and reproductive issues in people with PCOS. It is designed to work by acting like a natural hormone in the body that helps control blood sugar and reduces appetite.
Also referred to as Semaglutide.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is testing whether semaglutide can improve ovulation and weight in people with PCOS and obesity.
- Who it's for
- You may be able to join if you are a girl or woman aged 12 to 35, have PCOS, are obese, and are on or off metformin.
- What's involved
- You will take semaglutide for 10 months. You will have regular visits and tests to track weight and reproductive health.
- Time commitment
- The study lasts 10 months and includes periodic clinic visits and health checks.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 12 to 35, women only
You may be able to join if
- Female
- 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
- If \<18 years, initial BMI percentile ≥95
You likely can't join if
- Diagnosed with or have a family history of medullary thyroid carcinoma (MTC) or Multiple Endocrine Neoplasia syndrome type 2 (MEN2).
- 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...
- 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%
See the full eligibility criteria
- Female
- 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
- 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 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
- Diagnosed with or have a family history of medullary thyroid carcinoma (MTC) or Multiple Endocrine Neoplasia syndrome type 2 (MEN2).
- 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...
- 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.
The study team makes the final eligibility decision.
Where it is enrolling
- Aurora, Colorado, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 12 years to 35 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Aurora, Colorado, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.