Trial Outcomes & Findings for The Effect of Nitroglycerin on the Intrauterine Device (IUD) Insertion Experience in Nulliparous Women (NCT NCT01490073)

NCT ID: NCT01490073

Last Updated: 2019-04-26

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 24 participants
• Primary outcome timeframe: 30-45 minutes after insertion of nitroglycerin ointment
• Results posted on: 2019-04-26

Participant Flow

Participant milestones

Measure	Active Nitroglycerin Ointment Insertion of nitroglycerin ointment: Nitroglycerin ointment inserted into the vagina 30-45 minutes prior to IUD insertion	Placebo Ointment Insertion of placebo ointment: Placebo ointment inserted into the vagina 30-45 minutes prior to IUD insertion
Overall Study STARTED	12	12
Overall Study COMPLETED	12	12
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Active Nitroglycerin Ointment n=12 Participants Insertion of nitroglycerin ointment: Nitroglycerin ointment inserted into the vagina 30-45 minutes prior to IUD insertion	Placebo Ointment n=12 Participants Insertion of placebo ointment: Placebo ointment inserted into the vagina 30-45 minutes prior to IUD insertion	Total n=24 Participants Total of all reporting groups
Age, Continuous	28.3 years STANDARD_DEVIATION 6.9 • n=5 Participants	25.7 years STANDARD_DEVIATION 4.4 • n=7 Participants	27.04 years STANDARD_DEVIATION 5.7 • n=5 Participants
Sex: Female, Male Female	12 Participants n=5 Participants	12 Participants n=7 Participants	24 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	12 Participants n=5 Participants	9 Participants n=7 Participants	21 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants
Current smoker	4 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants

PRIMARY outcome

Timeframe: 30-45 minutes after insertion of nitroglycerin ointment

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.

Outcome measures

Measure	Active Nitroglycerin Ointment n=12 Participants Insertion of nitroglycerin ointment: Nitroglycerin ointment inserted into the vagina 30-45 minutes prior to IUD insertion	Placebo Ointment n=12 Participants Insertion of placebo ointment: Placebo ointment inserted into the vagina 30-45 minutes prior to IUD insertion
Patient-reported Pain at Passage of Insertion Device Through Cervix, as Measured on a 100 mm VAS	55.8 mm Standard Deviation 25.2	53.9 mm Standard Deviation 28.1

SECONDARY outcome

Timeframe: 30-45 minutes after insertion of nitroglycerin ointment

Provider ease with intrauterine device insertion measured on a 100 mm VAS. VAS (visual analog scale) anchors: 0 indicates easiest insertion imaginable, 100 indicates most difficult insertion imaginable

Outcome measures

Measure	Active Nitroglycerin Ointment n=12 Participants Insertion of nitroglycerin ointment: Nitroglycerin ointment inserted into the vagina 30-45 minutes prior to IUD insertion	Placebo Ointment n=12 Participants Insertion of placebo ointment: Placebo ointment inserted into the vagina 30-45 minutes prior to IUD insertion
Provider Ease With Intrauterine Device Insertion Measured on a 100 mm VAS	29.4 mm Standard Deviation 23.8	22.8 mm Standard Deviation 29.9

Adverse Events

Active Nitroglycerin Ointment

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo Ointment

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Elizabeth Micks

University of Washington

Phone: 206-616-4939

Email: emicks@uw.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place