Oral Contraceptives in the Metabolic Syndrome

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Virginia Commonwealth University
ClinicalTrials.gov Identifier:
NCT00205504
First received: September 13, 2005
Last updated: May 24, 2013
Last verified: May 2013
Results First Received: January 25, 2012  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Prevention
Conditions: Metabolic Syndrome X
Insulin Resistance
Obesity
Cardiovascular Diseases
Intervention: Drug: Ortho Tri Cyclen

  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
Obese Women

Women with Body Mass Index (BMI) >30 kg/m².

Note: Only two arms were analyzed for the results. Women who were candidates for taking oral contraceptive pills and had the metabolic syndrome could not be recruited. That is because some inclusion criteria for metabolic syndrome are actually exclusion criteria for safe oral contraceptive use.

Lean Women Women with Body Mass Index)BMI <25 kg/m²

Participant Flow:   Overall Study
    Obese Women     Lean Women  
STARTED     21     15  
COMPLETED     14     15  
NOT COMPLETED     7     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Obese Women

Women with Body Mass Index (BMI) >30 kg/m².

Note: Only two arms were analyzed for the results. Women who were candidates for taking oral contraceptive pills and had the metabolic syndrome could not be recruited. That is because some inclusion criteria for metabolic syndrome are actually exclusion criteria for safe oral contraceptive use.

Lean Women Women with Body Mass Index)BMI <25 kg/m²
Total Total of all reporting groups

Baseline Measures
    Obese Women     Lean Women     Total  
Number of Participants  
[units: participants]
  21     15     36  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     21     15     36  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  25.3  ± 6.9     21.4  ± 2.3     23.4  ± 5.8  
Gender  
[units: participants]
     
Female     21     15     36  
Male     0     0     0  
Region of Enrollment  
[units: participants]
     
United States     21     15     36  



  Outcome Measures
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1.  Primary:   Changes in Insulin Sensitivity Associated With Oral Contraceptive (OC) Use Compared Among (1) Obese Women and (2) Lean Women   [ Time Frame: Baseline and 6 months ]

2.  Secondary:   Changes in Lipid Profile Compared Associated With OC Use Among (1) Obese Women and (2) Lean Women   [ Time Frame: Baseline and 6 months ]

3.  Secondary:   Inflammatory Marker Changes, High Sensitive C-reactive Protein (Hs-CRP) and Adiponectin, Associated With OC Use Compared Among (1) Obese Women and (2) Lean Women   [ Time Frame: Baseline and 6 months ]

4.  Secondary:   Changes in Estrogen Metabolites (Plasma) Associated With OC Use Compared Among (1) Obese Women and (2) Lean Women   [ Time Frame: Baseline and 6 months ]

5.  Secondary:   Changes in Waist-to-Hip Ratio Associated With OC Use Compared Among (1) Obese Women and (2) Lean Women   [ Time Frame: Baseline and 6 months ]

6.  Secondary:   Inflammatory Marker Changes (MCP-1) Associated With OC Use Compared Among (1) Obese Women and (2) Lean Women   [ Time Frame: Baseline and 6 months ]

7.  Secondary:   Changes in Blood Pressure Associated With OC Use Compared Among (1) Obese Women and (2) Lean Women   [ Time Frame: Baseline and 6 months ]

8.  Secondary:   Changes in Body Mass Index (BMI) Associated With OC Use Compared Among (1) Obese Women and (2) Lean Women   [ Time Frame: Baseline and 6 months ]

9.  Secondary:   Changes in Waist Circumference Associated With OC Use Compared Among (1) Obese Women and (2) Lean Women   [ Time Frame: Baseline and 6 months ]

10.  Secondary:   Inflammatory Marker Changes, Soluble Vascular Cell Adhesion Molecule (sVCAM) and Soluble Intercellular Adhesion Molecule (sICAM), Associated With OC Use Compared Among (1) Obese Women and (2) Lean Women   [ Time Frame: Baseline and 6 months ]


  Serious Adverse Events


  Other Adverse Events


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


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: Kai Cheang, Principal Investigator
Organization: Virginia Commonwealth University
phone: 804-828-9698
e-mail: kicheang@vcu.edu


Publications of Results:

Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT00205504     History of Changes
Other Study ID Numbers: AD Williams
Study First Received: September 13, 2005
Results First Received: January 25, 2012
Last Updated: May 24, 2013
Health Authority: United States: Institutional Review Board