Lifestyle Intervention and Metformin for Women With Polycystic Ovary Syndrome (PCOS)
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ClinicalTrials.gov Identifier: NCT00151411 |
Recruitment Status
:
Completed
First Posted
: September 9, 2005
Results First Posted
: November 8, 2011
Last Update Posted
: March 21, 2018
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Polycystic Ovary Syndrome | Drug: Metformin Drug: Placebo Behavioral: Lifestyle Intervention | Phase 2 |
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 |

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

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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00151411
United States, Pennsylvania | |
Penn State Milton S. Hershey Medical Center | |
Hershey, Pennsylvania, United States, 17033 |
Principal Investigator: | Richard Legro, M.D. | Milton S. Hershey Medical Center |
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 Key Record Dates |
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 |