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Study of Immune Cell Changes in the Genital Tract 2 Months After Initiation of an IUD for Contraception (CHIC)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01240811
First Posted: November 15, 2010
Last Update Posted: July 22, 2013
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):
Sharon Achilles, University of Pittsburgh
Results First Submitted: January 15, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Basic Science
Conditions: Genital Tract Mucosal Immunity
Genital Tract Microflora
Interventions: Drug: IUD placement
Drug: Levonorgestrel IUD
Drug: Copper T380A IUD

  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
Participants were recruited from the medical clinic and our database of prior research participants. Public advertisements included listing on our website, letters to the database mailing list, flyers placed on local college campuses, mailings to faculty, internet postings on Craig’s list, and informational booths at on or off campus fairs.

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
Control-No IUD Healthy volunteers not at risk of pregnancy and not using any hormonal contraception.
Levonorgestrel IUS Healthy volunteers seeking contraception with IUD. Randomized to LNG IUS.
Copper T380A IUD Healthy volunteers seeking contraception with IUD. Randomized to Copper T380A IUD.

Participant Flow:   Overall Study
    Control-No IUD   Levonorgestrel IUS   Copper T380A IUD
STARTED   8   17   17 
COMPLETED   8   16   16 
NOT COMPLETED   0   1   1 
Physician Decision                0                1                0 
Withdrawal by Subject                0                0                1 



  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.
No text entered.

Reporting Groups
  Description
Control-No IUD Healthy volunteers not at risk of pregnancy and not using any hormonal contraception.
Levonorgestrel IUS Healthy volunteers seeking contraception with IUD. Randomized to LNG IUS.
Copper T380A IUD Healthy volunteers seeking contraception with IUD. Randomized to Copper T380A IUD.
Total Total of all reporting groups

Baseline Measures
   Control-No IUD   Levonorgestrel IUS   Copper T380A IUD   Total 
Overall Participants Analyzed 
[Units: Participants]
 8   17   17   42 
Age 
[Units: Participants]
       
<=18 years   0   0   0   0 
Between 18 and 65 years   8   17   17   42 
>=65 years   0   0   0   0 
Age 
[Units: Years]
Mean (Standard Deviation)
 28  (6)   26  (6)   27  (4)   26  (5) 
Gender 
[Units: Participants]
       
Female   8   17   17   42 
Male   0   0   0   0 
Region of Enrollment 
[Units: Participants]
       
United States   8   17   17   42 


  Outcome Measures

1.  Primary:   %CD4 Expressing CCR5 HIV Co-receptor in the Cervix and Endometrium   [ Time Frame: 2 months ]

2.  Secondary:   Vaginal and Endometrial Flora   [ Time Frame: 2 Months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
We identified a need for methods optimization prior to proceeding with a large definitive study to determine contraceptive hormone induced changes in genital tract immune cell populations.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Sharon Achilles, MD, PhD
Organization: University of Pittsburgh
phone: 412-641-1403
e-mail: achisx@upmc.edu



Responsible Party: Sharon Achilles, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01240811     History of Changes
Other Study ID Numbers: PRO09100199
First Submitted: November 11, 2010
First Posted: November 15, 2010
Results First Submitted: January 15, 2013
Results First Posted: July 22, 2013
Last Update Posted: July 22, 2013