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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease	Intervention/treatment	Phase
Polycystic Ovary Syndrome	Drug: Metformin; Drug: Placebo; Behavioral: Lifestyle Intervention	Phase 2

Detailed Description:

PCOS is characterized by excess circulating androgen levels and chronic anovulation. PCOS is also characterized by insulin resistance and hyperinsulinemia. Several recent studies in a variety of non-hospital based populations have provided evidence that the incidence of hyperandrogenic chronic anovulation is in the range of 4-6% of the female population. Improvements in insulin sensitivity in women with PCOS, either through lifestyle changes or through pharmaceutical intervention, have consistently resulted in a marked improvement in the reproductive and metabolic abnormalities in PCOS. The primary objective in the adult female population is to determine that combination therapy will improve ovulatory frequency. Secondary objective is to improve circulating hyperandrogenemia and insulin sensitivity then single agent therapy. The primary objective of the adolescent population is to determine that the combination therapy will improve hyperandrogenemia. Secondary objective is to improve ovulatory frequency and insulin sensitivity than just the use of a single agent therapy.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	114 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Triple (Participant, Care Provider, Investigator)
Primary Purpose:	Treatment
Official Title:	The Effect of Combination Therapy With Lifestyle Intervention and Metformin in Females With Polycystic Ovary Syndrome
Study Start Date :	October 2004
Actual Primary Completion Date :	March 2008
Actual Study Completion Date :	March 2008

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Experimental: Metformin; Metformin	Drug: Metformin; Medication was initiated in a step-up fashion every five days, from one tablet per day to four (500 mg per tablet). Behavioral: Lifestyle Intervention; 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.
Placebo Comparator: Placebo; Placebo	Drug: Placebo; Placebo Behavioral: Lifestyle Intervention; 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.

Outcome Measures

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Primary Outcome Measures :

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

Secondary Outcome Measures :

1. Ovulation Rate [ Time Frame: 6 months ]
   Count of ovulations per subject during the treatment period.
2. Change in Insulin Sensitivity Index After 6 Months of Treatment [ Time Frame: baseline and 6 months ]

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	12 Years to 39 Years (Child, Adult)
Sexes Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

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

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

United States, Pennsylvania
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033

Sponsors and Collaborators

Milton S. Hershey Medical Center

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Investigators

Principal Investigator:	Richard Legro, M.D.	Milton S. Hershey Medical Center

More Information

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Additional Information:

Click here for more information about this study 

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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.

Responsible Party:	Richard S. Legro, M.D., Professor, Obstetrics and Gynecology and Public Health Sciences, Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier:	NCT00151411 History of Changes
Other Study ID Numbers:	2003-172; HD-02-012
First Posted:	September 9, 2005
Results First Posted:	November 8, 2011
Last Update Posted:	March 21, 2018
Last Verified:	March 2018

Keywords provided by Richard S. Legro, M.D., Milton S. Hershey Medical Center:

Polycystic Ovary Syndrome (PCOS); Anovulation; Elevated Testosterone

Additional relevant MeSH terms:

Syndrome; Polycystic Ovary Syndrome; Disease; Pathologic Processes; Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases	Adnexal Diseases; Genital Diseases, Female; Gonadal Disorders; Endocrine System Diseases; Metformin; Hypoglycemic Agents; Physiological Effects of Drugs