Clinical Trials Logo
  1. Home
  2. Contraception
  3. NCT04339049
  4. Details
NCT04339049 Clinical Trial

Comparative Efficacy of Lidocaine Spray Versus Vaginal Misoprostol in IUD Insertion

Contraception Clinical Trial

Official title:
Comparative Efficacy of Lidocaine Spray Versus Vaginal Misoprostol in Reducing Pain During IUD Insertion in Adolescents and Nulliparous Women: a Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04339049
Other study ID # lidocaine IUD
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date May 1, 2020
Est. completion date July 30, 2021

Study information
Verified date November 2021
Source Cairo University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

the aim of the present study is to compare the safety and efficacy of lidocaine spray versus misoprostol in reducing pain during IUD insertion in adolescents and nulliparous women

Recruitment information / eligibility
Status Completed
Enrollment 147
Est. completion date July 30, 2021
Est. primary completion date July 17, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group N/A and older
Eligibility Inclusion Criteria: - adolescent and young nulliparous women requesting IUD insertion Exclusion Criteria: - multiparous women, contraindications to IUD insertion or to study drugs

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• lidocaine spray
four puffs (10 mg/puff) of lidocaine spray before tenaculum placement plus vaginal placebo 3 hours before IUD insertion
• vaginal misoprostol
vaginal misoprostol 200 mcg given 3 hours before IUD insertion plus four puffs of saline spray before tenaculum placement
• placebo
vaginal placebo given 3 hours before IUD insertion plus four puffs of saline spray before tenaculum placement

Locations
Country Name City State
Egypt Ahmed Ashour Giza

Sponsors (2)
Lead Sponsor Collaborator
Cairo University Algazeerah hospital

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary pain during IUD insertion pain during IUD insertion evaluated by visual analog scale where 0 denotes no pain and 10 cm denotes the worst pain imaginable 5 minutes
Secondary duration of IUD insertion duration of IUD insertion from speculum in to speculum out 5 minutes
See also
  Status Clinical Trial Phase
Completed NCT02577601 - Impact of Combined Hormonal Contraceptives on UPA Phase 4
Completed NCT03153644 - Improving Contraceptive Care for Women With Medical Conditions
Completed NCT04112095 - Adherence With Continuous-dose Oral Contraceptive: Evaluation of Self-Selection and Use Phase 3
Recruiting NCT05521646 - Implementing Best Practice Postpartum Contraceptive Services Through a Quality Improvement Initiative N/A
Active, not recruiting NCT04291001 - Ovarian Function With ENG Implant and UPA Use Early Phase 1
Completed NCT04568980 - Assessment of Contraceptive Safety and Effectiveness in Cystic Fibrosis
Completed NCT03438682 - Real World Effectiveness and Safety of Hysteroscopic (Essure®) Compared to Laparoscopic Sterilization
Active, not recruiting NCT01948882 - Evaluation of Safety and Effectiveness of the Essure (Model ESS505) Device to Prevent Pregnancy in Women N/A
Enrolling by invitation NCT04997499 - Adolescent Subcutaneous (SQ) Injection Video Validation N/A
Recruiting NCT03589040 - Darunavir and Rilpivirine Interactions With Etonogestrel Contraceptive Implant Phase 2
Completed NCT04463680 - Rifampin and the Contraceptive Implant Phase 4
Completed NCT03154125 - Sayana® Press Extension Study Phase 3
Withdrawn NCT03725358 - A Cluster-RCT to Increase the Uptake of LARCs Among Adolescent Females and Young Women in Cameroon. N/A
Completed NCT02957630 - "E4/DRSP Endocrine Function, Metabolic Control and Hemostasis Study" Phase 1/Phase 2
Completed NCT02718222 - Impact and Performance of Institutionalizing Immediate Post-partum IUD Services N/A
Completed NCT02456584 - Pharmacodynamics and Pharmacokinetics Study of Existing DMPA Contraceptive Methods Phase 1
Recruiting NCT02121067 - LNG-IUS at 2 Weeks Postpartum Phase 4
Terminated NCT02169869 - Immediate Postplacental IUD Insertion N/A
Recruiting NCT02292056 - Medication Safety and Contraceptive Counseling for Reproductive Aged Women With Psychiatric Conditions N/A
Withdrawn NCT01930994 - Kenya Sino-implant (II) PK Study N/A