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Hormonal Contraception and Vaginal Health

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ClinicalTrials.gov Identifier: NCT00612508
Recruitment Status : Completed
First Posted : February 11, 2008
Results First Posted : November 8, 2012
Last Update Posted : November 8, 2012
Sponsor:
Collaborator:
Oregon Clinical and Translational Research Institute
Information provided by (Responsible Party):
Jeffrey Jensen, Oregon Health and Science University

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)
Enrollment 14
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Desogen NuvaRing
Hide Arm/Group Description oral contraceptive intravaginal contraception
Period Title: Overall Study
Started 7 7
Completed 4 [1] 3 [2]
Not Completed 3 4
Reason Not Completed
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
Arm/Group Title Desogen NuvaRing Total
Hide Arm/Group Description oral contraceptive intravaginal contraception Total of all reporting groups
Overall Number of Baseline Participants 7 7 14
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants 7 participants 14 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
7
 100.0%
7
 100.0%
14
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 7 participants 7 participants 14 participants
28  (4) 24  (3.4) 25.8  (4.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants 7 participants 14 participants
Female
7
 100.0%
7
 100.0%
14
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 7 participants 7 participants 14 participants
7 7 14
1.Primary Outcome
Title Thickness of the Vaginal Epithelium (in mm)With Means and Standard Deviations Reported.
Hide Description Histologic evalation of vaginal sections was performed to measured and record the absolute thickness of the vaginal epithelium. Baseline findings were compared to biopsies after three and six cycles of treatment. Mean values were compared using T-test for paired data for baseline and 84 days, and baseline and 168 days
Time Frame baseline, 84 days, 168 days
Hide Outcome Measure Data
Hide Analysis Population Description

A total of 14 subjects (7 R, 7 P) were randomized and had an initial biopsy; 11 (6 R, 5 P) returned for a biopsy at 3rd cycle (84 days), and 6 (3 R, 4 P) 6th cycle (168 days).

The analysis used a paired T test comparing the baseline mean to the mean as the end of the 3rd cylce (e.g. 84 days) and the 6th cycle (168 days)

Arm/Group Title Desogen NuvaRing
Hide Arm/Group Description:
oral contraceptive = P (pill)
intravaginal contraception = R (ring)
Overall Number of Participants Analyzed 5 6
Mean (Standard Deviation)
Unit of Measure: mm
mean difference at 84 days 0.01  (0.06) -0.005  (0.048)
mean difference at 168 days -0.02  (0.09) .007  (0.028)
2.Secondary Outcome
Title Adverse Events
Hide Description Self-reported treatment-related and serious adverse events
Time Frame over 168 days
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects that were enrolled were assessed for adverse events at each study visit. Measure is number of participants with event
Arm/Group Title Oral Contraceptive Intravaginal Ring Contraceptive
Hide Arm/Group Description:
Desogen (ethinyl estradiol & desogestrel) = P (pill)
nuvaring (ethinyl estradiol & desogestrel) = R (ring)
Overall Number of Participants Analyzed 7 7
Measure Type: Number
Unit of Measure: participants
1 0
Time Frame Every 6 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Desogen NuvaRing
Hide Arm/Group Description oral contraceptive intravaginal contraception
All-Cause Mortality
Desogen NuvaRing
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Desogen NuvaRing
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/7 (0.00%)      0/7 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Desogen NuvaRing
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/7 (14.29%)      0/7 (0.00%)    
Reproductive system and breast disorders     
Bleeding from vagina * 1 [1]  1/7 (14.29%)  1 0/7 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, SNOMED-CT 289530006
[1]
Minor bleeding and pain associated with biopsy
Did not fully recruit; small number of subject
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
Layout table for Results Point of Contact information
Name/Title: Oregon Health & Science University
Organization: Women's Health Research Unit
Phone: 503-494-3666
EMail: whru@ohsu.edu
Layout table for additonal information
Responsible Party: Jeffrey Jensen, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT00612508    
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