Lifestyle Intervention and Metformin for Women With Polycystic Ovary Syndrome (PCOS) - Full Text View

Purpose

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	Intervention	Phase
Polycystic Ovary Syndrome	Drug: Metformin Drug: Placebo Behavioral: Lifestyle Intervention	Phase 2


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (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

Resource links provided by NLM:

MedlinePlus related topics: Polycystic Ovary Syndrome

Drug Information available for: Metformin Metformin hydrochloride

U.S. FDA Resources

Further study details as provided by Richard S. Legro, M.D., Milton S. Hershey Medical Center:

Primary Outcome Measures:

Change in Testosterone After 6 Months of Treatment [ Time Frame: baseline and 6 months ]
The investigators hypothesize that combination therapy will result in a greater improvement in hyperandrogenemia than single agent therapy.

Secondary Outcome Measures:

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 ]


Enrollment:	114
Study Start Date:	October 2004
Study Completion Date:	March 2008
Primary Completion Date:	March 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.

Arms

Assigned Interventions

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.

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.

Eligibility


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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00151411

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

Additional Information:

Click here for more information about this study This link exits the ClinicalTrials.gov site

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
Study First Received:	September 8, 2005
Results First Received:	June 7, 2011
Last Updated:	September 26, 2016

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

ClinicalTrials.gov processed this record on July 21, 2017