Hormonal Contraception and Vaginal Health

This study has been completed.
Sponsor:
Collaborator:
Oregon Clinical and Translational Research Institute
Information provided by (Responsible Party):
Jeffrey Jensen, Oregon Health and Science University
ClinicalTrials.gov Identifier:
NCT00612508
First received: January 29, 2008
Last updated: October 9, 2012
Last verified: October 2012
Results First Received: December 16, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Open Label
Conditions: Contraceptive Usage
Vaginal Epithelial Disruption
Interventions: Drug: Desogen (ethinyl estradiol and desogestrel)
Drug: NuvaRing (ethinyl estradiol and etonogestrel)

  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
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
Desogen oral contraceptive
NuvaRing intravaginal contraception

Participant Flow:   Overall Study
    Desogen     NuvaRing  
STARTED     7     7  
COMPLETED     4 [1]   3 [2]
NOT COMPLETED     3     4  
Withdrawal by Subject                 3                 4  
[1] 5 desogen users returned for the 84 day biopsy
[2] 6 nuvaring users returned for the 84 day biopsy



  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
Desogen oral contraceptive
NuvaRing intravaginal contraception
Total Total of all reporting groups

Baseline Measures
    Desogen     NuvaRing     Total  
Number of Participants  
[units: participants]
  7     7     14  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     7     7     14  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  28  ± 4     24  ± 3.4     25.8  ± 4.1  
Gender  
[units: participants]
     
Female     7     7     14  
Male     0     0     0  
Region of Enrollment  
[units: participants]
     
United States     7     7     14  



  Outcome Measures
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1.  Primary:   Thickness of the Vaginal Epithelium (in mm)With Means and Standard Deviations Reported.   [ Time Frame: baseline, 84 days, 168 days ]

2.  Secondary:   Adverse Events   [ Time Frame: over 168 days ]


  Serious Adverse Events


  Other Adverse Events


  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.


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
Did not fully recruit; small number of subject  


Results Point of Contact:  
Name/Title: Oregon Health & Science University
Organization: Women's Health Research Unit
phone: 503-494-3666
e-mail: whru@ohsu.edu


No publications provided


Responsible Party: Jeffrey Jensen, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT00612508     History of Changes
Other Study ID Numbers: OHSU RES 2017
Study First Received: January 29, 2008
Results First Received: December 16, 2010
Last Updated: October 9, 2012
Health Authority: United States: Institutional Review Board