Lifestyle Intervention and Metformin for Women With Polycystic Ovary Syndrome (PCOS)

This study has been completed.

Study NCT00151411 Information provided by Penn State University

First Received on September 8, 2005. Last Updated on October 3, 2011 History of Changes

Results First Received: June 7, 2011

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Caregiver, Investigator); Primary Purpose: Treatment
Condition:	Polycystic Ovary Syndrome
Interventions:	Drug: Metformin Drug: Placebo

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Metformin	Metformin 2000mg/d (2 500mg tablets taken twice a day) initiated in a step-up fashion
Placebo	Placebo (2 tablets twice a day) initiated in a step-up fashion

Participant Flow: Overall Study

	Metformin	Placebo
STARTED	55	59
COMPLETED	22	16
NOT COMPLETED	33	43
Lost to Follow-up	15	19
Withdrawal by Subject	12	20
Adverse Event	6	0
Pregnancy	0	4

Baseline Characteristics

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Reporting Groups

	Description
Metformin	Metformin 2000mg/d (2 500mg tablets taken twice a day) initiated in a step-up fashion
Placebo	Placebo (2 tablets twice a day) initiated in a step-up fashion

Baseline Measures

	Metformin	Placebo	Total
Number of Participants [units: participants]	55	59	114
Age [units: participants]
<=18 years	0	0	0
Between 18 and 65 years	55	59	114
>=65 years	0	0	0
Age [units: years] Mean ± Standard Deviation	29 ± 4.5	28.8 ± 4.6	28.9 ± 4.6
Gender [units: participants]
Female	55	59	114
Male	0	0	0
Region of Enrollment [units: participants]
United States	55	59	114

Outcome Measures

1. Primary:

Change in Testosterone After 6 Months of Treatment [ Time Frame: baseline and 6 months ]

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2. Secondary:

The Investigators Hypothesize That Combination Therapy Will Result in a Greater Improvement in Ovulatory Frequency and Insulin Sensitivity That Single Agent Therapy. [ Time Frame: baseline and monthly, up to six months post-randomization ]

Results not yet posted. Anticipated Posting Date: No text entered. Safety Issue: No

Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: Sandy Eyer
Organization: Penn State Hershey
phone: 717-531-1540
e-mail: seyer@hmc.psu.edu

No publications provided by Penn State University

Publications automatically indexed to this study:

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.

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. Epub 2010 Dec 30.

Responsible Party:	Richard S. Legro, M.D., The Pennsylvania State University
ClinicalTrials.gov Identifier:	NCT00151411 History of Changes
Other Study ID Numbers:	2003-172, HD-02-012
Study First Received:	September 8, 2005
Results First Received:	June 7, 2011
Last Updated:	October 3, 2011
Health Authority:	United States: Food and Drug Administration