Try our beta test site

Impact of Lactate-Containing Vaginal Lubricant on Sexual Dysfunction in Young Breast Cancer Survivors

This study has been completed.
Sponsor:
Collaborator:
Medical Research Collaborating Center, Seoul, Korea
Information provided by (Responsible Party):
Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT00981305
First received: September 20, 2009
Last updated: December 1, 2016
Last verified: October 2016
Results First Received: October 9, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Sexual Dysfunction
Breast Cancer Survivors
Interventions: Drug: Lactate-containing vaginal lubricant
Drug: Placebo vaginal lubricant

  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
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
  Description
Lactate-containing Vaginal Lubricant

apply 3cc of lactate-containing vaginal lubricant before sexual intercourse or sleeping for 8wks (at least 3 times per week)

Lactate-containing vaginal lubricant: vaginal applying at least 3cc of lactate-containing lubricant at the time of sexual intercourse or before sleeping for 8 weeks (at least 3 times/week)

Placebo

apply 3cc of placebo vaginal lubricant before sexual intercourse or sleeping for 8wks (at least 3 times per week)

Placebo vaginal lubricant: vaginal applying at least 3cc of placebo lubricant at the time of sexual intercourse or before sleeping for 8 weeks (at least 3 times/week)


Participant Flow:   Overall Study
    Lactate-containing Vaginal Lubricant   Placebo
STARTED   69   67 
COMPLETED   50   57 
NOT COMPLETED   19   10 



  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
Lactate-containing Vaginal Lubricant

apply 3cc of lactate-containing vaginal lubricant before sexual intercourse or sleeping for 8wks (at least 3 times per week)

Lactate-containing vaginal lubricant: vaginal applying at least 3cc of lactate-containing lubricant at the time of sexual intercourse or before sleeping for 8 weeks (at least 3 times/week)

Placebo

apply 3cc of placebo vaginal lubricant before sexual intercourse or sleeping for 8wks (at least 3 times per week)

Placebo vaginal lubricant: vaginal applying at least 3cc of placebo lubricant at the time of sexual intercourse or before sleeping for 8 weeks (at least 3 times/week)

Total Total of all reporting groups

Baseline Measures
   Lactate-containing Vaginal Lubricant   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 50   57   107 
Age 
[Units: Years]
Mean (Standard Deviation)
 48.6  (6.0)   49.0  (5.2)   48.8  (5.6) 
Gender 
[Units: Participants]
Count of Participants
     
Female      50 100.0%      57 100.0%      107 100.0% 
Male      0   0.0%      0   0.0%      0   0.0% 
Parity 
[Units: Pregnancies]
Median (Full Range)
 2 
 (0 to 3) 
 2 
 (0 to 5) 
 2 
 (0 to 5) 
Body mass index 
[Units: Kg/m^2]
Mean (Standard Deviation)
 23.1  (2.4)   23.3  (3.3)   23.2  (2.9) 
Menopause 
[Units: Participants]
     
Yes   35   41   76 
No   15   16   31 
Tamoxifen treatment 
[Units: Participants]
     
Yes   33   40   73 
No   17   17   34 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change of Pain Score of Female Sexual Function Index   [ Time Frame: Baseline and 8 weeks ]

2.  Secondary:   Change of a Total and Other Five Domains of Female Sexual Function Index Score   [ Time Frame: Baseline and 8 weeks ]

3.  Secondary:   Change of Vaginal pH   [ Time Frame: Baseline and 8 weeks ]

4.  Secondary:   Change of Vaginal Maturation Index   [ Time Frame: Baseline and 8 weeks ]


  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:  
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: Myung Jae Jeon
Organization: SeoulNUH
phone: 82-2-2072-1916
e-mail: jeonmj@snu.ac.kr



Responsible Party: Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT00981305     History of Changes
Other Study ID Numbers: SNUH 0905-037-281
Study First Received: September 20, 2009
Results First Received: October 9, 2016
Last Updated: December 1, 2016