Lidocaine In-situ Gel Prior to Intrauterine Device Insertion in Women With no Previous Vaginal Delivery

NCT03166111 | Completed Phase 3

• 1 other identifier: LISITU
• Study Type: interventional
• Target: 216
• Locations: 1 country
• Sites: 1

Brief Summary

Long-acting reversible contraception methods are highly effective methods for reduction of the unplanned pregnancy rate worldwide. The intrauterine device is a single procedure that provides reliable, effective and long term contraception for many women. However, the insertion procedure can be associated with a troublesome degree of pain that prevent some women from choosing its use. Different interventions have been described to decrease pain perception during intrauterine device insertion with no agreement on an effective one. Pre-insertion oral ibuprofen, diclofenac, nitroprusside, local anesthetics as lidocaine and prostaglandins has been reported with variable degrees of success .

Conditions

Contraception

Outcome Measures

Primary Outcomes (1)

• The difference in pain scores during intrauterine device insertion

  using visual analog scale from 0 to 10

  10 minutes

Study Arms (2)

lidocaine group

EXPERIMENTAL

lidocaine in-situ gel inserted vaginally

Drug: lidocaine gel

placebo group

PLACEBO COMPARATOR

placebo gel inserted vaginally

Drug: placebo gel

Interventions

lidocaine gel DRUG

syringe filled with 5 ml gel to be self-administered vaginal 10 minutes prior to insertion

lidocaine group

placebo gel DRUG

syringe filled with 5 ml gel to be self-administered vaginal 10 minutes prior to insertion

placebo group

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Non-pregnant women
• Women that did not receive any analgesics or misoprostol in the 24 hours prior to insertion
• Women who delivered only by caesarean section

You may not qualify if:

• Women with any uterine abnormalities as congenital anomalies, endometrial lesions, adenomyosis, fibroids
• Those with a Category 3 or 4 conditions for intrauterine device insertion according to the WHO Medical Eligibility Criteria for contraceptive use
• Allergy to lidocaine.
• Women refuse to participate in the study

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut University

Asyut, Egypt

Location

Related Publications (1)

• Abbas AM, Abd Ellah NH, Hosny MA, Abdellah MS, Ali MK. Self-administrated vaginal 2% lidocaine in-situ gel for pain relief during copper intrauterine device insertion in women with previous caesarean delivery only: a randomised, double-blind placebo-controlled trial. Eur J Contracept Reprod Health Care. 2021 Apr;26(2):132-138. doi: 10.1080/13625187.2020.1868427. Epub 2021 Feb 4.

  PMID: 33539256 DERIVED

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: May 23, 2017
• First Posted: May 24, 2017
• Study Start: September 1, 2017
• Primary Completion: March 31, 2020
• Study Completion: May 31, 2020
• Last Updated: October 6, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)