A Study of Continuous Oral Contraceptives and Doxycycline

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jeffrey Jensen, Oregon Health and Science University
ClinicalTrials.gov Identifier:
NCT00480532
First received: May 30, 2007
Last updated: December 17, 2012
Last verified: December 2012
Results First Received: May 21, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Contraceptives, Oral
Interventions: Drug: Lybrel
Drug: Doxycycline
Drug: Oracea
Drug: Placebo
Drug: Doxycycline 100bid x5 days at the time of bleeding
Drug: Subantimicrobial doxycycline daily
Drug: placebo daily

  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
Recruitment at Oregon Health and Science University (OHSU) and University of Hawaii (UH

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
None

Reporting Groups
  Description
Placebo (Treatment) Placebo (for treatment portion of the study)
Doxy (7 Day Treatment Arm) Doxycycline 100 mg po bid x 7 days taken when bleeding occurred
Placebo (Prevention) Placebo for prevention portion of the study
Subantibmicrobial Dose Doxy Doxycycline 40mg (sustained release) once daily for 84 days

Participant Flow:   Overall Study
    Placebo (Treatment)     Doxy (7 Day Treatment Arm)     Placebo (Prevention)     Subantibmicrobial Dose Doxy  
STARTED     33     33     33     32  
COMPLETED     31     29     29     31  
NOT COMPLETED     2     4     4     1  
Withdrawal by Subject                 2                 4                 3                 1  
Protocol Violation                 0                 0                 1                 0  



  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
Placebo (Treatment) Placebo (for treatment portion of the study)
Doxy (7 Day Treatment Arm) Doxycycline 100 mg po bid x 7 days taken when bleeding occurred
Placebo (Prevention) Placebo for prevention portion of the study
Subantibmicrobial Dose Doxy Doxycycline 40mg (sustained release) once daily for 84 days
Total Total of all reporting groups

Baseline Measures
    Placebo (Treatment)     Doxy (7 Day Treatment Arm)     Placebo (Prevention)     Subantibmicrobial Dose Doxy     Total  
Number of Participants  
[units: participants]
  33     33     33     32     131  
Age  
[units: participants]
         
<=18 years     0     0     0     1     1  
Between 18 and 65 years     33     33     33     31     130  
>=65 years     0     0     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  28.0  ± 6.6     27.5  ± 6.8     27.8  ± 5.4     28.6  ± 6.1     28.0  ± 7.0  
Gender  
[units: participants]
         
Female     33     33     33     32     131  
Male     0     0     0     0     0  
Region of Enrollment  
[units: participants]
         
United States     33     33     33     32     131  



  Outcome Measures
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1.  Primary:   Differences in Bleeding Patterns Between Study Groups.   [ Time Frame: The outcome was also assessed for day 1 to 84 ]

2.  Secondary:   Subject Satisfaction.   [ Time Frame: Assessed on day 112 of the study (the end of the study period). This outcome does not represent a change from baseline. It was assessed at the end of the study period. ]

3.  Secondary:   Subject Compliance   [ Time Frame: Assessed on day 112 of the study (the end of the study period). The outcome reflects the number of subjects who did not miss pills during the entire 112 day study. It does not represent a change from baseline. ]


  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
Treatment Arm: Subjects had difficulty understanding when to start and stop treatment.


  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: Bliss Kaneshiro
Organization: University of Hawaii (UH)
phone: 808-203-6500
e-mail: bkaneshiro@ucera.org


Publications of Results:

Responsible Party: Jeffrey Jensen, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT00480532     History of Changes
Other Study ID Numbers: OHSU FAMPLAN 2907
Study First Received: May 30, 2007
Results First Received: May 21, 2012
Last Updated: December 17, 2012
Health Authority: United States: Food and Drug Administration