Vaginal Isonicotinic Acid Hydrazide Administration Prior to Insertion Levonorgestrel-releasing Intrauterine System

NCT04500028 | Completed Phase 4 DMC

• 1 other identifier: aswu/355/3/19
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 1

Brief Summary

To investigate whether vaginal isonicotinic acid hydrazide (INH) administered before the levonorgestrel-releasing intrauterine system(IUs) insertion reduces failed insertions, insertion-related complications, and pain in Women With no Previous Vaginal Delivery.

Conditions

IUCD Complication

Outcome Measures

Primary Outcomes (1)

• The difference in pain scores during intrauterine device insertion

  The difference in pain scores during intrauterine device insertion using visual analog scale from 0 to 10

  10 minutes

Secondary Outcomes (1)

• duration of IUD insertion

  10 minutes

Study Arms (2)

INH

EXPERIMENTAL

3 vaginal tablet of isonicotinic acid hydrazide (900mg) ( inserted by the study nurse 4 hours before IUD insertion.

Drug: INH

Placebo Comparator

PLACEBO COMPARATOR

one tablet of placebo inserted by the study nurse 4 hours before IUD insertion.

Drug: Placebo Comparator

Interventions

INH DRUG

3 vaginal tablet of isonicotinic acid hydrazide (900mg) inserted by the study nurse 4 hours before IUD insertion.

INH

Placebo Comparator DRUG

3 tablet of placebo inserted by the study nurse 4 hours before IUD insertion.

Placebo Comparator

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: Non-pregnant women who delivered only by cesarean section
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• Women with any uterine abnormalities such as congenital anomalies, endometrial lesions, adenomyosis, or 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 isonicotinic acid hydrazide
• known psychiatric disorders ( anxiety and depression) and chronic use of medications that could interfere with pain perception (antidepressants and anticonvulsants)
• Women refuse to participate in the study

Sponsors & Collaborators

• Aswan University Hospital: lead

Study Sites (1)

Aswan University Hospital

Aswān, 81528, Egypt

Location

Study Officials

• nahla w Shady, md

  Aswan universirty

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: double blind randomized controlled trial
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: A Professor

Model Details: double blind randomized controlled trial

Study Record Dates

• First Submitted: August 2, 2020
• First Posted: August 5, 2020
• Study Start: August 1, 2020
• Primary Completion: October 31, 2021
• Study Completion: December 1, 2021
• Last Updated: May 13, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)