Phase 3
N=12
Metabolic and Neuro-Endocrine Effect of Treating PCOS in Adolescents
PCOS
Bottom Line
View on ClinicalTrials.gov: NCT03981861 ↗Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Feb 2021
Primary outcome: Primary: Oral Glucose Tolerance Test — 0.9 mg/dL
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Metformin and Spironolactone (Drug)
- Age
- Pediatric, Adult · 13+ yrs
- Sex
- Female
- Sponsor
- Children's Mercy Hospital Kansas City
- Primary completion
- Jul 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Oral Glucose Tolerance Test |
0.9 | — |
| PRIMARY Total Testosterone |
-12.57 | — |
| PRIMARY Free Testosterone |
-0.15 | — |
| PRIMARY Dehydroepiandrosterone Sulfate (DHEAS) |
-25.89 | — |
| PRIMARY Body Mass Index (BMI) |
-1.3 | — |
Summary
To exam in the effect of a combination of low dose Metformin and Spironolactone on functional brain MRI, menstrual regulation and metabolism in adolescents with PCOS.
Eligibility Criteria
Inclusion Criteria
- Generally healthy
- Meeting Androgen Excess Society (AES) diagnostic criteria of PCOS: Menstrual Dysfunction or PCO ovaries on ultrasound AND clinical or biochemical hyperandrogenism
- Normal liver and kidney function
- No chronic illnesses except for stable, treated hypothyroidism
Exclusion Criteria
- Use of metformin and/or spironolactone within the last 6 months
- Currently on either oral hormonal contraception or other forms of hormonal contraception such as Depo-Provera, NuvaRing
- Current or past pregnancy
- Currently sexually active
- Psychiatric disorder based on self/parental report
- Type 2 diabetes (blood glucose > 200mg/dl on OGTT)
- Anemia (Hct 1.0 mg)
- Abnormal liver transaminases > 2 x the upper limit of normal range
- Potassium elevated outside the reference range (in non-hemolyzed blood sample)
Data sourced from ClinicalTrials.gov (NCT03981861). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.