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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01534520
Recruitment Status : Completed
First Posted : February 16, 2012
Results First Posted : December 22, 2016
Last Update Posted : December 22, 2016
Society of Family Planning
Information provided by (Responsible Party):
Sharon Achilles, University of Pittsburgh

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition: Pain
Interventions: Drug: Lidocaine
Drug: Placebo

  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
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] 
Adverse Event                0                1 
[1] 1 subject withdrew consent at time of uterine sound attempt due to intolerable pain

  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
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.
[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

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

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
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  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

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

Responsible Party: Sharon Achilles, University of Pittsburgh Identifier: NCT01534520     History of Changes
Other Study ID Numbers: SFP-RBR001
First Submitted: February 13, 2012
First Posted: February 16, 2012
Results First Submitted: May 20, 2016
Results First Posted: December 22, 2016
Last Update Posted: December 22, 2016