NCT01490073

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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2012

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 8, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 12, 2011

Completed
3 months until next milestone

Study Start

First participant enrolled

March 1, 2012

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2012

Completed
6.5 years until next milestone

Results Posted

Study results publicly available

April 26, 2019

Completed
Last Updated

April 26, 2019

Status Verified

April 1, 2019

Enrollment Period

8 months

First QC Date

December 8, 2011

Results QC Date

February 28, 2019

Last Update Submit

April 3, 2019

Conditions

ContraceptionPain

Keywords

Intrauterine devicePainContraceptionNitroglycerinNitric oxide donorIntrauterine device insertion

Outcome Measures

Primary Outcomes (1)

  • Patient-reported Pain at Passage of Insertion Device Through Cervix, as Measured on a 100 mm VAS

    Patient-reported pain at passage of insertion device through cervix, as measured on a 100 mm VAS. VAS anchors: 0 indicates no pain, and 100 indicates worst pain imaginable.

    30-45 minutes after insertion of nitroglycerin ointment

Secondary Outcomes (1)

  • Provider Ease With Intrauterine Device Insertion Measured on a 100 mm VAS

    30-45 minutes after insertion of nitroglycerin ointment

Study Arms (2)

Active nitroglycerin ointment

ACTIVE COMPARATOR
Drug: Insertion of nitroglycerin ointment

Placebo ointment

PLACEBO COMPARATOR
Drug: Insertion of placebo ointment

Interventions

Insertion of nitroglycerin ointmentDRUG

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

Active nitroglycerin ointment
Insertion of placebo ointmentDRUG

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

Placebo ointment

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • age 18-45 years,
  • generally healthy,
  • requesting a LNG-IUS for contraception as the primary indication

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Planned Parenthood Columbia Willamette

Portland, Oregon, 97212, United States

Location

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Elizabeth Micks
Organization
University of Washington
emicks@uw.edu
206-616-4939

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Instructor and Fellow in Family Planning, Department of Obstetrics and Gynecology

Study Record Dates

First Submitted

December 8, 2011

First Posted

December 12, 2011

Study Start

March 1, 2012

Primary Completion

November 1, 2012

Study Completion

November 1, 2012

Last Updated

April 26, 2019

Results First Posted

April 26, 2019

Record last verified: 2019-04

Locations

US(2)