NCT00714233

Brief Summary

A 24 week study to compare the use of Metformin, birth control pills and a carefully planned intensive lifestyle program that includes weight loss and exercise. These approaches will be compared to placebo (a pill that contains no active substances. Metformin, birth control pills and the lifestyle management program will be used on this research study to compare their ability to:

  1. 1.reduce fasting glucose levels
  2. 2.reduce androgen hormone levels
  3. 3.improve sex steroid binding, and
  4. 4.improve lipids (fatty substances in the blood)

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
43

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Aug 2002

Longer than P75 for phase_3

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2002

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2004

Completed
3.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

July 8, 2008

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 14, 2008

Completed
3.2 years until next milestone

Results Posted

Study results publicly available

September 16, 2011

Completed
Last Updated

May 15, 2015

Status Verified

May 1, 2011

Enrollment Period

1.7 years

First QC Date

July 8, 2008

Results QC Date

April 8, 2011

Last Update Submit

April 29, 2015

Conditions

Polycystic Ovary Syndrome

Keywords

Polycystic Ovary SyndromeOverweight Adolescent GirlsIrregular Menstrual Cycles

Outcome Measures

Primary Outcomes (1)

  • Measure Number of Adolescent Girls With PCOS Who Can be Successfully Recruited Into a Randomized Clinical Trial That Includes Lifestyle Modification

    The measure is to determine a number of successfully recruited overweight or obese adolescents to a randomized trial of lifestyle therapy in the community of Rochester, NY

    24 week

Secondary Outcomes (5)

  • Weight Loss in Lifestyle Intervention Group

    baseline and 24 weeks

  • Change in Free Androgen Index (FAI)

    baseline and 24 weeks

  • Change in SHBG

    baseline and 24 weeks

  • Triglyceride Concentration by Treatment Group

    baseline and 24 weeks

  • Change in Fasting Glucose

    baseline and 24 weeks

Study Arms (4)

1

EXPERIMENTAL

Metformin

Drug: Metformin

2

EXPERIMENTAL

Oral Contraceptive Pills

Drug: Oral Contraceptive Pills (Yasmin)

3

ACTIVE COMPARATOR

lifestyle modification program

Behavioral: Lifestyle Modification

4

PLACEBO COMPARATOR

placebo to active metformin arm

Drug: placebo

Interventions

MetforminDRUG

Metformin 425mg. capsules, 2 capsules BID x 24 weeks

1
Oral Contraceptive Pills (Yasmin)DRUG

Yasmin oral contraceptive tabs; 1 tab daily x 24 weeks

Also known as: Yasmin oral COntraceptive tabs
2
Lifestyle ModificationBEHAVIORAL

weekly classes x 24 weeks for training in diet, exercise and behavior modification skills

3
placeboDRUG

placebo to the active metformin arm. 2 capsules BID x 24 weeks.

Also known as: pharmacy matched placebo capsules
4

Eligibility Criteria

Age12 Years - 18 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Menstrual irregularity defined as cycle length \> 45 days
  • Overweight as BMI \> 25
  • Clinical evidence of hirsuitism or acne
  • Testosterone \> 50ng/dL

You may not qualify if:

  • History of diabetes mellitus
  • History of Cushing's disease
  • History of hyperprolactinemia
  • Untreated hypo or hyperthyroidism
  • History of adrenal hyperplasia
  • Significant renal impairment
  • Received oral contraceptives, estrogen or progestin or other drugs known to effect lipoprotein metabolism within 2 months of starting the study
  • Exercise \> 10 hours per week

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Polycystic Ovary SyndromeMenstruation Disturbances

Interventions

Metformindrospirenone and ethinyl estradiol combination

Condition Hierarchy (Ancestors)

Ovarian CystsCystsNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

BiguanidesGuanidinesAmidinesOrganic Chemicals

Results Point of Contact

Title
Kathleen M Hoeger MD MPH
Organization
University of Rochester
Kathy_hoeger@urmc.rochester.edu
5852757891

Study Officials

  • Kathleen M Hoeger, MD

    University of Rochester

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 8, 2008

First Posted

July 14, 2008

Study Start

August 1, 2002

Primary Completion

April 1, 2004

Study Completion

December 1, 2007

Last Updated

May 15, 2015

Results First Posted

September 16, 2011

Record last verified: 2011-05