Trial Outcomes & Findings for Metabolic and Neuro-Endocrine Effect of Treating PCOS in Adolescents (NCT NCT03981861)

NCT ID: NCT03981861

Last Updated: 2021-02-23

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: PHASE2/PHASE3
• Target enrollment: 12 participants
• Primary outcome timeframe: Change Measures: Baseline & 6 Months
• Results posted on: 2021-02-23

Participant Flow

Participant milestones

Measure	Overall Study The pilot study was a non-controlled open label drug intervention study in a sample of adolescent girls attending a polycystic ovary syndrome (PCOS) clinic. Subjects received 6 months combination drug therapy with a combination of low dose metformin and spironolactone.
Overall Study STARTED	12
Overall Study COMPLETED	9
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Measure	Overall Study The pilot study was a non-controlled open label drug intervention study in a sample of adolescent girls attending a polycystic ovary syndrome (PCOS) clinic. Subjects received 6 months combination drug therapy with a combination of low dose metformin and spironolactone.
Overall Study Withdrawal by Subject	3

Baseline Characteristics

Metabolic and Neuro-Endocrine Effect of Treating PCOS in Adolescents

Baseline characteristics by cohort

Measure	Treatment n=12 Participants Treatment with Metformin and Spironolactone Metformin and Spironolactone: Oral Metformin tablet (500 mg/tablet) twice daily for 6 months. Oral Spironolactone tablet (50 mg/tablet) once daily for 6 months.
Age, Continuous	16 years STANDARD_DEVIATION 1 • n=5 Participants
Sex/Gender, Customized female	12 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	10 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants
Race (NIH/OMB) White	8 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment North America	12 participants n=5 Participants
whole body insulin sensitivity index (WBISI)	3.67 μU/ml STANDARD_DEVIATION 4.39 • n=5 Participants
Body Mass Index (BMI)	36.7 kg/m2 STANDARD_DEVIATION 10.9 • n=5 Participants

PRIMARY outcome

Timeframe: Change Measures: Baseline & 6 Months

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

Outcome measures

Measure	Overall Study n=9 Participants This was a pilot non-controlled open label drug intervention study in a sample of adolescent girls attending a polycystic ovary syndrome (PCOS) clinic. Subjects received 6 months combination drug therapy with a combination of low dose metformin and spironolactone.
Oral Glucose Tolerance Test	0.9 mg/dL Standard Deviation 2.9

PRIMARY outcome

Timeframe: Change Measures: Baseline & 6 Months

Total Testosterone measured in ng/dL

Outcome measures

Measure	Overall Study n=9 Participants This was a pilot non-controlled open label drug intervention study in a sample of adolescent girls attending a polycystic ovary syndrome (PCOS) clinic. Subjects received 6 months combination drug therapy with a combination of low dose metformin and spironolactone.
Total Testosterone	-12.57 ng/dL Standard Deviation 11.35

PRIMARY outcome

Timeframe: Change Measures: Baseline & 6 Months

Free Testosterone measured in ng/dL

Outcome measures

Measure	Overall Study n=9 Participants This was a pilot non-controlled open label drug intervention study in a sample of adolescent girls attending a polycystic ovary syndrome (PCOS) clinic. Subjects received 6 months combination drug therapy with a combination of low dose metformin and spironolactone.
Free Testosterone	-0.15 ng/dL Standard Deviation 0.24

PRIMARY outcome

Timeframe: Change Measures: Baseline & 6 Months

DHEAS measured in mcg/dL

Outcome measures

Measure	Overall Study n=9 Participants This was a pilot non-controlled open label drug intervention study in a sample of adolescent girls attending a polycystic ovary syndrome (PCOS) clinic. Subjects received 6 months combination drug therapy with a combination of low dose metformin and spironolactone.
Dehydroepiandrosterone Sulfate (DHEAS)	-25.89 mcg/dL Standard Deviation 79.07

PRIMARY outcome

Timeframe: Change Measures: Baseline & 6 Months

Body Mass Index measured in kg/m2

Outcome measures

Measure	Overall Study n=9 Participants This was a pilot non-controlled open label drug intervention study in a sample of adolescent girls attending a polycystic ovary syndrome (PCOS) clinic. Subjects received 6 months combination drug therapy with a combination of low dose metformin and spironolactone.
Body Mass Index (BMI)	-1.3 kg/m2 Standard Deviation 0.6

Adverse Events

Overall Study

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Tania Burgert

ChildrensMHC

Phone: 203 676 4545

Email: tsburgert@cmh.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place