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

• Status: Completed
• Trial end date: 2012-11-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Oregon Health and Science University
• Collaborators: American College of Obstetricians and Gynecologists; Bayer
• Treatments: Nitroglycerin

Criteria

Inclusion Criteria:

1. age 18-45 years,

2. generally healthy,

3. requesting a LNG-IUS for contraception as the primary indication

Exclusion Criteria:

1. Previous pregnancy beyond 20 weeks;

2. previous IUD placement or attempted IUD placement;

3. previous cervical cold knife cone (CKC) or loop electrosurgical excision procedure (LEEP);

4. contraindication to LNG-IUS (including pregnancy, fibroids that distort the uterine cavity, exam consistent with PID, allergy to any component of the LNG-IUS, etc);

5. concurrent use of any form of nitrate therapy or medications that interact with nitroglycerin (such as phosphodiesterase V inhibitors);

6. known allergy to nitroglycerine or common topical ointment ingredients;

7. known renal or hepatic impairment;

8. history of hypertensive or hypotensive disorder;

9. history of migraine, cluster headaches, or vascular headaches;

10. history of myocardial infarction;

11. uncontrolled congestive heart failure;

12. unstable angina;

13. tobacco or alcohol amblyopia;

14. congenital optic atrophy;

15. blood pressure less than 90/55 or greater than 150/100 in office prior to speculum exam