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Hormonal Contraception and Vaginal Health

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.
ClinicalTrials.gov Identifier: NCT00612508
Recruitment Status : Completed
First Posted : February 11, 2008
Results First Posted : November 8, 2012
Last Update Posted : November 8, 2012
Information provided by (Responsible Party):

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label)
Conditions: Contraceptive Usage
Vaginal Epithelial Disruption
Interventions: Drug: Desogen (ethinyl estradiol and desogestrel)
Drug: NuvaRing (ethinyl estradiol and etonogestrel)

  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
Desogen oral contraceptive
NuvaRing intravaginal contraception

Participant Flow:   Overall Study
    Desogen   NuvaRing
STARTED   7   7 
COMPLETED   4 [1]   3 [2] 
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

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

Baseline Measures
   Desogen   NuvaRing   Total 
Overall Participants Analyzed 
[Units: Participants]
 7   7   14 
[Units: Participants]
<=18 years   0   0   0 
Between 18 and 65 years   7   7   14 
>=65 years   0   0   0 
[Units: Years]
Mean (Standard Deviation)
 28  (4)   24  (3.4)   25.8  (4.1) 
[Units: Participants]
Female   7   7   14 
Male   0   0   0 
Region of Enrollment 
[Units: Participants]
United States   7   7   14 

  Outcome Measures

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

  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

  More Information

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: Oregon Health & Science University
Organization: Women's Health Research Unit
phone: 503-494-3666
e-mail: whru@ohsu.edu

Responsible Party: Jeffrey Jensen, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT00612508     History of Changes
Other Study ID Numbers: OHSU RES 2017
First Submitted: January 29, 2008
First Posted: February 11, 2008
Results First Submitted: December 16, 2010
Results First Posted: November 8, 2012
Last Update Posted: November 8, 2012