Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Therapy to Prevent Sexual Pain in Breast Cancer Survivors

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
OHSU Knight Cancer Institute
ClinicalTrials.gov Identifier:
NCT01539317
First received: December 21, 2011
Last updated: July 7, 2015
Last verified: July 2015
Results First Received: June 5, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Crossover Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Conditions: Vulvodynia
Dyspareunia
Breast Cancer
Menopause
Interventions: Drug: Topical liquid lidocaine
Drug: Topical saline

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
January 2012 to June 2013; Women’s Health Research Unit (WHRU) at Oregon Health and Science University (OHSU) in Portland, OR

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
Topical Liquid Lidocaine Topical liquid lidocaine: Comparison of topical liquid lidocaine to placebo on application to the vulvar vestibule
Topical Saline Topical liquid lidocaine: Comparison of topical liquid lidocaine to placebo on application to the vulvar vestibule

Participant Flow:   Overall Study
    Topical Liquid Lidocaine     Topical Saline  
STARTED     25     25  
COMPLETED     24     25  
NOT COMPLETED     1     0  
Screening Error. Deleted from analysis.                 1                 0  



  Baseline Characteristics
  Hide 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
  Description
Topical Liquid Lidocaine Topical liquid lidocaine: Comparison of topical liquid lidocaine to placebo on application to the vulvar vestibule
Topical Saline Topical liquid lidocaine: Comparison of topical liquid lidocaine to placebo on application to the vulvar vestibule
Total Total of all reporting groups

Baseline Measures
    Topical Liquid Lidocaine     Topical Saline     Total  
Number of Participants  
[units: participants]
  25     25     50  
Age  
[units: years]
Mean (Standard Deviation)
  56.5  (8.5)     54.7  (8.9)     55.34  (8.77)  
Gender, Customized  
[units: participants]
     
Female     25     25     50  
Ethnicity (NIH/OMB)  
[units: participants]
     
Hispanic or Latino     1     0     1  
Not Hispanic or Latino     24     25     49  
Unknown or Not Reported     0     0     0  
Race (NIH/OMB)  
[units: participants]
     
American Indian or Alaska Native     0     0     0  
Asian     1     1     2  
Native Hawaiian or Other Pacific Islander     1     0     1  
Black or African American     0     0     0  
White     22     22     44  
More than one race     1     2     3  
Unknown or Not Reported     0     0     0  
Region of Enrollment  
[units: participants]
     
United States     25     25     50  



  Outcome Measures

1.  Primary:   Location of Pain in Postmenopausal Dyspareunia   [ Time Frame: Enrollment visit ]

2.  Primary:   Prevention of Entry Dyspareunia With Non-hormonal Therapy   [ Time Frame: From the date of enrollment to 6 months ]
Results not yet reported.   Anticipated Reporting Date:   08/2015   Safety Issue:   No

3.  Secondary:   Improvement of Quality of Sexual Life.   [ Time Frame: From time of enrollment until 6 months later ]
Results not yet reported.   Anticipated Reporting Date:   08/2015   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide 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
No text entered.


  More Information
  Hide More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Martha Goetsch
Organization: Oregon Health and Science University
phone: 503-494-3666
e-mail: whru@ohsu.edu


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: OHSU Knight Cancer Institute
ClinicalTrials.gov Identifier: NCT01539317     History of Changes
Other Study ID Numbers: OHSU IRB 7630
Study First Received: December 21, 2011
Results First Received: June 5, 2015
Last Updated: July 7, 2015
Health Authority: United States: Institutional Review Board