This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

Therapy to Prevent Sexual Pain in Breast Cancer Survivors

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Martha Goetsch, OHSU Knight Cancer Institute
ClinicalTrials.gov Identifier:
NCT01539317
First received: December 21, 2011
Last updated: April 12, 2017
Last verified: April 2017
Results First Received: June 5, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Participant, 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 
Overall Participants Analyzed 
[Units: Participants]
 25   25   50 
Age 
[Units: Years]
Mean (Standard Deviation)
 56.5  (8.5)   54.7  (8.9)   55.34  (8.77) 
Sex/Gender, Customized 
[Units: Participants]
     
Female   25   25   50 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
     
Hispanic or Latino      1   4.0%      0   0.0%      1   2.0% 
Not Hispanic or Latino      24  96.0%      25 100.0%      49  98.0% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
     
American Indian or Alaska Native      0   0.0%      0   0.0%      0   0.0% 
Asian      1   4.0%      1   4.0%      2   4.0% 
Native Hawaiian or Other Pacific Islander      1   4.0%      0   0.0%      1   2.0% 
Black or African American      0   0.0%      0   0.0%      0   0.0% 
White      22  88.0%      22  88.0%      44  88.0% 
More than one race      1   4.0%      2   8.0%      3   6.0% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0% 
Region of Enrollment 
[Units: Participants]
     
United States   25   25   50 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Prevention of Entry Dyspareunia With Non-hormonal Therapy   [ Time Frame: During Phase II (0-4 weeks) and during Phase III (5-12 weeks) ]

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

3.  Secondary:   Improvement of Quality of Sexual Life - Visit 1   [ Time Frame: Visit 1 (Enrollment) ]

4.  Secondary:   Improvement of Quality of Sexual Life - Visit 2   [ Time Frame: Visit 2 (Week 4) ]

5.  Secondary:   Improvement of Quality of Sexual Life - Visit 3   [ Time Frame: Visit 3 (End of Study) ]


  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: Martha Goetsch, 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: April 12, 2017