Lifestyle Intervention and Metformin for Women With Polycystic Ovary Syndrome (PCOS)
This study has been completed.
Sponsor:
Milton S. Hershey Medical Center
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Richard S. Legro, M.D., Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier:
NCT00151411
First received: September 8, 2005
Last updated: December 20, 2012
Last verified: December 2012
- Full Text View
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
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 |
Phase 2 |
| 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 |
| Official Title: | The Effect of Combination Therapy With Lifestyle Intervention and Metformin in Females With Polycystic Ovary Syndrome |
Resource links provided by NLM:
Further study details as provided by Milton S. Hershey Medical Center:
Primary Outcome Measures:
- Change in Testosterone After 6 Months of Treatment [ Time Frame: baseline and 6 months ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]
| 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).
|
|
Placebo Comparator: Placebo
Placebo
|
Drug: Placebo
Placebo
|
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) |
| Genders 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
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:
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 |
| Study First Received: | September 8, 2005 |
| Results First Received: | June 7, 2011 |
| Last Updated: | December 20, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by 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 September 28, 2016