Try our beta test site
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...

Self-administered Intravaginal 2% Lidocaine Gel Prior to Intrauterine Device Insertion in Nulliparous Women (LIVIIN)

This study has been completed.
Sponsor:
Collaborator:
Society of Family Planning
Information provided by (Responsible Party):
Sharon Achilles, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT01534520
First received: February 13, 2012
Last updated: October 27, 2016
Last verified: October 2016
Results First Received: May 20, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition: Pain
Interventions: Drug: Lidocaine
Drug: Placebo

  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
In total, 79 women presenting for IUD insertion at OPC, UPP, and GMO were approached for participation.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
  • 2 patients were removed from the study. Patients were considered screen failures before randomization to an arm.
  • 18 declined participation; 10 (56%) reported “time concerns” as their primary reason for declining.

Reporting Groups
  Description
Group 1: Intravaginal 2% Lidocaine Gel 4 ml of 2% lidocaine gel for self vaginal insertion
Group 2: Intravaginal Placebo Gel Intravaginal insertion of 4ml of placebo gel (K-Y Jelly)

Participant Flow:   Overall Study
    Group 1: Intravaginal 2% Lidocaine Gel   Group 2: Intravaginal Placebo Gel
STARTED   30   29 
COMPLETED   30   28 [1] 
NOT COMPLETED   0   1 
Adverse Event                0                1 
[1] 1 subject withdrew consent at time of uterine sound attempt due to intolerable pain



  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.
Randomization is blinded.

Reporting Groups
  Description
Group 1: Intravaginal 2% Lidocaine Gel

4mL of 2% lidocaine gel for vaginal self-administration

)

Group 2: Intravaginal Placebo Gel 4mL placebo gel (K-Y Jelly) for vaginal self-administration
Total Total of all reporting groups

Baseline Measures
   Group 1: Intravaginal 2% Lidocaine Gel   Group 2: Intravaginal Placebo Gel   Total 
Overall Participants Analyzed 
[Units: Participants]
 30   29   59 
Age, Customized [1] 
[Units: Participants]
     
Between 14-50   30   29   59 
[1] Randomization was blinded.
Gender 
[Units: Participants]
Count of Participants
     
Female      30 100.0%      29 100.0%      59 100.0% 
Male      0   0.0%      0   0.0%      0   0.0% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change in Pain From Baseline to IUD Insertion   [ Time Frame: change in pain score from baseline (before IUD insertion) to time of IUD insertion ]

2.  Secondary:   To Evaluate Patient Experience of Self-inserting the Intravaginal Study Gel Prior to IUD   [ Time Frame: After inserting the gel but prior to IUD insertion ]

3.  Secondary:   Percentage of IUDs Considered by Physicians Easy to Insert   [ Time Frame: Directly after IUD insertion ]

4.  Secondary:   Need for Pain Medication up to 7 Days   [ Time Frame: 7 days post-insertion ]


  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: Dionne Best
Organization: UPittsburgh
phone: 412-641-5496
e-mail: dbest@upmc.edu


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

Responsible Party: Sharon Achilles, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01534520     History of Changes
Other Study ID Numbers: SFP-RBR001
Study First Received: February 13, 2012
Results First Received: May 20, 2016
Last Updated: October 27, 2016