We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Oral Contraceptives in the Metabolic Syndrome

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00205504
First Posted: September 20, 2005
Last Update Posted: October 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Virginia Commonwealth University
Results First Submitted: January 25, 2012  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Conditions: Metabolic Syndrome X
Insulin Resistance
Obesity
Cardiovascular Diseases
Intervention: Drug: Ortho Tri Cyclen

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

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
  Hide Baseline Characteristics

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.
No text entered.

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 
Overall Participants Analyzed 
[Units: Participants]
 21   15   36 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      21 100.0%      15 100.0%      36 100.0% 
>=65 years      0   0.0%      0   0.0%      0   0.0% 
Age 
[Units: Years]
Mean (Standard Deviation)
 25.3  (6.9)   21.4  (2.3)   23.4  (5.8) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      21 100.0%      15 100.0%      36 100.0% 
Male      0   0.0%      0   0.0%      0   0.0% 
Region of Enrollment 
[Units: Participants]
     
United States   21   15   36 


  Outcome Measures
  Show All Outcome Measures

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


  Limitations and Caveats
  Hide 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
No text entered.


  More Information
  Hide More Information

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


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: HM4060
First Submitted: September 13, 2005
First Posted: September 20, 2005
Results First Submitted: January 25, 2012
Results First Posted: May 7, 2012
Last Update Posted: October 12, 2017