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The Effect of Nitroglycerin on the Intrauterine Device (IUD) Insertion Experience in Nulliparous Women

NCT01490073 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2019-04-26

Study results available
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Summary

Increasing ease of access of long-acting birth control methods, like intrauterine devices (IUDs), is an important way to reduce the risk of unintended pregnancy. Unfortunately, fear of IUD insertion in women who have not had children is common among health care providers and women alike, and this limits IUD use. To increase acceptance of this highly effective birth control method, there is a need to explore new, low cost, and easily applied methods to improve the insertion experience. This is a pilot study to evaluate the effectiveness and acceptability of nitroglycerin ointment applied vaginally to improve the IUD insertion experience for both patient and provider. The investigators hypothesis is that nitroglycerin ointment will decrease the pain associated with IUD insertion.

Conditions

  • Contraception
  • Pain

Interventions

DRUG

Insertion of nitroglycerin ointment

Nitroglycerin ointment inserted into the vagina 30-45 minutes prior to IUD insertion

DRUG

Insertion of placebo ointment

Placebo ointment inserted into the vagina 30-45 minutes prior to IUD insertion

Sponsors & Collaborators

  • American College of Obstetricians and Gynecologists

    collaborator OTHER

  • Bayer

    collaborator INDUSTRY

  • Oregon Health and Science University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-03-01
Primary Completion
2012-11-01
Completion
2012-11-01

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01490073 on ClinicalTrials.gov