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

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ClinicalTrials.gov Identifier: NCT01534520
Recruitment Status : Completed
First Posted : February 16, 2012
Results First Posted : December 22, 2016
Last Update Posted : December 22, 2016
Sponsor:
Collaborator:
Society of Family Planning
Information provided by (Responsible Party):
Sharon Achilles, University of Pittsburgh

Brief Summary:
This study is designed to evaluate if self-inserted intravaginal 2% lidocaine gel is effective at decreasing pain during intrauterine device insertion in nulliparous women.

Condition or disease Intervention/treatment Phase
Pain Drug: Lidocaine Drug: Placebo Not Applicable

Detailed Description:

Intrauterine devices (IUDs) are among the most effective forms of reversible contraception. Numerous studies demonstrate their safety and efficacy in nulliparous women, however, uptake of IUDs in this group is low. One of the major barriers to women obtaining IUDs is fear of pain during insertion, as studies do demonstrate that nulliparous women experience more pain than parous women during IUD insertion. Studies evaluating various methods for pain control during IUD insertion have shown conflicting results, leaving the question unanswered as to what is the best method to decrease pain during IUD insertion.

This study aims to evaluate a novel approach to pain control by having women self-insert lidocaine gel into the vagina at least 5 minutes prior to IUD insertion. This will overcome some of the barriers from other studies where there may not have been ample time for the lidocaine to take effect, while at the same time eliminating the need for women to have multiple speculum exams. Although this is a novel approach to administering an anesthetic, we believe women will be interested in any intervention that may potentially alleviate pain during IUD insertion.

If this study does demonstrate that pain is decreased with self-inserted lidocaine compared to placebo gel, this will potentially eliminate one large barrier to nulliparous women receiving IUDs. Increased uptake of highly effective contraception in nulliparous women is just one of the many steps necessary towards decreasing unintended pregnancy.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 61 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Self-administered Intravaginal 2% Lidocaine Gel Prior to Intrauterine Device Insertion in Nulliparous Women: a Randomized Controlled Trial
Study Start Date : June 2012
Actual Primary Completion Date : May 2013
Actual Study Completion Date : May 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Group 1: Intravaginal 2% lidocaine gel
Intravaginal insertion of 4mL of 2% lidocaine gel
Drug: Lidocaine
Intravaginal insertion of 4mL 2% lidocaine gel
Other Names:
  • Lidocaine Jelly
  • Lidocaine Hydrochloride
Placebo Comparator: Group 2: Intravaginal placebo gel
Intravaginal insertion of 4mL of placebo gel ( K-Y Jelly)
Drug: Placebo
KY Jelly
Other Names:
  • K-Y Jelly
  • water based lubricant



Primary Outcome Measures :
  1. Change in Pain From Baseline to IUD Insertion [ Time Frame: change in pain score from baseline (before IUD insertion) to time of IUD insertion ]
    To assess change in pain from baseline to IUD insertion measured on a visual analog scale (VAS) from 0 mm (no pain) to 100 mm (worst pain in patient's life). This pain assessment was prior to (baseline) and at the time of IUD insertion following vaginal self-administration of study gel (either 2% lidocaine gel or placebo gel).


Secondary Outcome Measures :
  1. 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 ]
    Number of participants who rated self-application of study gel as "some what easy" or "very easy" on Likert scale

  2. Percentage of IUDs Considered by Physicians Easy to Insert [ Time Frame: Directly after IUD insertion ]
    The physician who conducted the study visit and IUD insertion was asked about the difficulty/ease in placing the IUD immediately following the procedure and the percentage of IUD insertions considered to be "easy" was calculated for each study group.

  3. Need for Pain Medication up to 7 Days [ Time Frame: 7 days post-insertion ]
    Number of women taking pain medication for at least one day following IUD insertion



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Ages Eligible for Study:   14 Years to 55 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria:

  • Nulliparous, as defined in this study as no history of pregnancy ≥ 24 weeks gestational age
  • Desires insertion of either levonorgestrel-releasing IUD (LNG-IUD) or copper T380A IUD (Cu-IUD)
  • No history of pregnancy in the last 6 weeks
  • Able to provide written informed consent in English and comply with all study procedures

Exclusion criteria:

  • Known allergy or hypersensitivity to lidocaine or other amino amide local anesthetics
  • Prior failed IUD insertion
  • Prior IUD use
  • Use of narcotic or benzodiazepine medication within the last 24 hours
  • U.S. Centers for Disease Control Medical Eligibility Criteria (MEC) category 3 or 4 classification for use of an IUD
  • Positive pregnancy test or reasonable risk of pregnancy due to unprotected heterosexual intercourse since the last menstrual period

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01534520


Locations
United States, Pennsylvania
Magee-Womens Hospital
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
University of Pittsburgh
Society of Family Planning
Investigators
Principal Investigator: Rachel B Rapkin, MD University of Pittsburgh

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Sharon Achilles, Assistant Professor, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01534520     History of Changes
Other Study ID Numbers: SFP-RBR001
First Posted: February 16, 2012    Key Record Dates
Results First Posted: December 22, 2016
Last Update Posted: December 22, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Sharon Achilles, University of Pittsburgh:
Intrauterine Device
Pain
Lidocaine

Additional relevant MeSH terms:
Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action