NCT00151411

Brief Summary

The purpose of this study is to determine if the combination therapy of lifestyle intervention and use of Metformin together will improve ovulation induction and hyperandrogenemia in women with polycystic ovary syndrome, by gathering data from adult and adolescent females.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
114

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Oct 2004

Typical duration for phase_2

Geographic Reach
1 country

1 active site

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

October 1, 2004

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

September 8, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 9, 2005

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2008

Completed
3.7 years until next milestone

Results Posted

Study results publicly available

November 8, 2011

Completed
Last Updated

March 21, 2018

Status Verified

March 1, 2018

Enrollment Period

3.4 years

First QC Date

September 8, 2005

Results QC Date

June 7, 2011

Last Update Submit

March 19, 2018

Conditions

Polycystic Ovary Syndrome

Keywords

Polycystic Ovary Syndrome (PCOS)AnovulationElevated Testosterone

Outcome Measures

Primary Outcomes (1)

  • Change in Testosterone After 6 Months of Treatment

    baseline and 6 months

Secondary Outcomes (2)

  • Ovulation Rate

    6 months

  • Change in Insulin Sensitivity Index After 6 Months of Treatment

    baseline and 6 months

Study Arms (2)

Metformin

EXPERIMENTAL

Metformin

Drug: MetforminBehavioral: Lifestyle Intervention

Placebo

PLACEBO COMPARATOR

Placebo

Drug: PlaceboBehavioral: Lifestyle Intervention

Interventions

MetforminDRUG

Medication was initiated in a step-up fashion every five days, from one tablet per day to four (500 mg per tablet).

Metformin
PlaceboDRUG

Placebo

Placebo
Lifestyle InterventionBEHAVIORAL

A combined intervention of diet and exercise was employed with the goal of achieving an average weight loss of at least 7% of initial body weight over six months with a prescription of 150 min/week of exercise combined with a low-calorie diet.

MetforminPlacebo

Eligibility Criteria

Age12 Years - 39 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Spontaneous intermenstrual periods of greater than or equal to 45 days or a total of 8 or less periods per year
  • Elevated testosterone levels
  • General good health
  • Off of current medications which may confound response to study medications

You may not qualify if:

  • Pregnancy
  • Lactose Intolerance
  • Medical Contraindications
  • Elevated Prolactin, 17hydroxyprogesterone, or Follicle stimulating hormone blood tests
  • Diabetes, liver, heart, kidney or uncorrected thyroid disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Penn State Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

Related Publications (2)

  • Ladson G, Dodson WC, Sweet SD, Archibong AE, Kunselman AR, Demers LM, Lee PA, Williams NI, Coney P, Legro RS. Effects of metformin in adolescents with polycystic ovary syndrome undertaking lifestyle therapy: a pilot randomized double-blind study. Fertil Steril. 2011 Jun 30;95(8):2595-8.e1-6. doi: 10.1016/j.fertnstert.2011.05.048.

    PMID: 21704212DERIVED

  • Ladson G, Dodson WC, Sweet SD, Archibong AE, Kunselman AR, Demers LM, Williams NI, Coney P, Legro RS. The effects of metformin with lifestyle therapy in polycystic ovary syndrome: a randomized double-blind study. Fertil Steril. 2011 Mar 1;95(3):1059-66.e1-7. doi: 10.1016/j.fertnstert.2010.12.002. Epub 2010 Dec 30.

    PMID: 21193187DERIVED

Related Links

MeSH Terms

Conditions

Polycystic Ovary SyndromeAnovulation

Interventions

Metformin

Condition Hierarchy (Ancestors)

Ovarian CystsCystsNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System Diseases

Intervention Hierarchy (Ancestors)

BiguanidesGuanidinesAmidinesOrganic Chemicals

Results Point of Contact

Title
Sandy Eyer
Organization
Penn State Hershey
seyer@hmc.psu.edu
717-531-1540

Study Officials

  • Richard Legro, M.D.

    Milton S. Hershey Medical Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
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, Obstetrics and Gynecology and Public Health Sciences

Study Record Dates

First Submitted

September 8, 2005

First Posted

September 9, 2005

Study Start

October 1, 2004

Primary Completion

March 1, 2008

Study Completion

March 1, 2008

Last Updated

March 21, 2018

Results First Posted

November 8, 2011

Record last verified: 2018-03

Locations

US(1)