Metabolic and Neuro-Endocrine Effect of Treating PCOS in Adolescents

NCT03981861 | Completed Phase 2 Results

• 1 other identifier: 16010020
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

PCOS

Outcome Measures

Primary Outcomes (5)

• Oral Glucose Tolerance Test

  Measurement of glucose and insulin at baseline and 2 hours after 75g of glucola.

  Change Measures: Baseline & 6 Months

• Total Testosterone

  Total Testosterone measured in ng/dL

  Change Measures: Baseline & 6 Months

• Free Testosterone

  Free Testosterone measured in ng/dL

  Change Measures: Baseline & 6 Months

• Dehydroepiandrosterone Sulfate (DHEAS)

  DHEAS measured in mcg/dL

  Change Measures: Baseline & 6 Months

• Body Mass Index (BMI)

  Body Mass Index measured in kg/m2

  Change Measures: Baseline & 6 Months

Study Arms (1)

Overall Study

EXPERIMENTAL

Treatment with Metformin and Spironolactone

Drug: Metformin and Spironolactone

Interventions

Metformin and Spironolactone DRUG

Oral Metformin tablet (500 mg/tablet) twice daily for 6 months. Oral Spironolactone tablet (50 mg/tablet) once daily for 6 months.

Overall Study

Eligibility Criteria

• Age: 13 Years - 21 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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 \< 35)
• Impaired kidney function (Baseline creatinine \> 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)

Sponsors & Collaborators

• Children's Mercy Hospital Kansas City: lead

Study Sites (1)

Children's Mercy Hospital

Kansas City, Missouri, 64108, United States

Location

MeSH Terms

Interventions

Metformin; Spironolactone

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals; Lactones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Limitations and Caveats

Early termination leading to small numbers of subjects analyzed; Technical problems with measurement leading to unreliable or uninterpretable data. Study was not published for this reason.

Results Point of Contact

• Title: Tania Burgert
• Organization: ChildrensMHC

tsburgert@cmh.edu

203 676 4545

Study Officials

• Tania Burgert, MD

  Children's Mercy Hospital Kansas City

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 7, 2019
• First Posted: June 11, 2019
• Study Start: July 2, 2016
• Primary Completion: July 9, 2018
• Study Completion: June 5, 2019
• Last Updated: February 23, 2021
• Results First Posted: February 23, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)