Status:
COMPLETED
The Effect of Nitroglycerin on the Intrauterine Device (IUD) Insertion Experience in Nulliparous Women
Lead Sponsor:
Oregon Health and Science University
Collaborating Sponsors:
American College of Obstetricians and Gynecologists
Bayer
Conditions:
Contraception
Pain
Eligibility:
FEMALE
18-45 years
Phase:
NA
Brief 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 i...
Detailed Description
Increasing acceptability and use of long acting reversible contraceptive methods like the intrauterine device (IUD) is an important strategy to reduce the risk of unintended pregnancy. Unfortunately, ...
Eligibility Criteria
Inclusion
- age 18-45 years,
- generally healthy,
- requesting a LNG-IUS for contraception as the primary indication
Exclusion
- Previous pregnancy beyond 20 weeks;
- previous IUD placement or attempted IUD placement;
- previous cervical cold knife cone (CKC) or loop electrosurgical excision procedure (LEEP);
- 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);
- concurrent use of any form of nitrate therapy or medications that interact with nitroglycerin (such as phosphodiesterase V inhibitors);
- known allergy to nitroglycerine or common topical ointment ingredients;
- known renal or hepatic impairment;
- history of hypertensive or hypotensive disorder;
- history of migraine, cluster headaches, or vascular headaches;
- history of myocardial infarction;
- uncontrolled congestive heart failure;
- unstable angina;
- tobacco or alcohol amblyopia;
- congenital optic atrophy;
- blood pressure less than 90/55 or greater than 150/100 in office prior to speculum exam
Key Trial Info
Start Date :
March 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2012
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT01490073
Start Date
March 1 2012
End Date
November 1 2012
Last Update
April 26 2019
Active Locations (2)
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1
Planned Parenthood Columbia Willamette
Portland, Oregon, United States, 97212
2
Oregon Health & Science University
Portland, Oregon, United States, 97239