CompletedNCT02388191Updated Jun 22, 2017Results posted

Naproxen for Pain Control With Intrauterine Device Insertion

An interventional study of Naproxen sodium and Placebo tablet in Contraception, sponsored by Planned Parenthood League of Massachusetts. Completed at 1 site in United States. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-06-22.

Sponsored by Planned Parenthood League of Massachusetts · Not applicable, Interventional, and Supportive care

Phase: Not applicable
Study type: Interventional
Enrollment: 119
Allocation: Randomized
Ages: 18 Years and older
Sex: Female

Study summary

The purpose of this study is:

To evaluate whether 550 mg of naproxen sodium reduces pain scores with IUD insertion on a 0-10cm visual analogue scale compared to placebo (primary outcome).
To evaluate whether 550 mg of naproxen sodium reduces pain scores with tenaculum placement, uterine sounding and post-procedurally on a 0-10 cm visual analog scale compared to placebo (secondary outcomes).
To establish if prophylactic naproxen sodium is acceptable for routine use prior to IUD insertion.

Hypothesis: The administration of naproxen sodium, 550mg orally, 1 hour prior to IUD insertion will lead to a reduction in pain scores associated with IUD insertion compared to placebo.

Conditions studied

Contraception

Keywords

Contraception
Naproxen
Intrauterine devices
Pain Control

In context

Lead sponsor

Planned Parenthood League of Massachusetts is the lead sponsor of 16 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: Female
Accepts healthy volunteers: Yes

Inclusion criteria

Age 18 years or older
Premenopausal
Presenting for insertion of any IUD type (i.e. Mirena, Paragard, Skyla)
English-speaking or non-English speaking with appropriate translator available

Exclusion criteria

Exclusion Criteria:

Currently pregnant or pregnant within the last 4 weeks
Not eligible for IUD insertion per PPLM's clinical protocols
Presenting for IUD removal and reinsertion
Any diagnosis of chronic pain (including fibromyalgia, endometriosis, dysmenorrhea, irritable bowel syndrome, interstitial cystitis)
Pain medications taken within 12 hours of enrollment
Misoprostol usage within 24 hours of enrollment
Any known allergy or contraindication to non-steroidal anti-inflammatory drugs (including active renal disease, active hepatic disease, gastric ulcer disease or gastritis, and bleeding disorders)

Study design

Phase: Not applicable
Primary purpose: Supportive care
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Triple (Participant, Care provider, Investigator)
Enrollment: 119 participants (actual)

Study arms

Experimental
Naproxen sodium
550 mg naproxen sodium
Drug: Naproxen sodium
Placebo comparator
Placebo
Placebo
Other: Placebo tablet

Interventions

DrugNaproxen sodium
550 mg, oral, on day 1. Number of Cycles: 1
OtherPlacebo tablet

What researchers measure

Primary outcomes

Pain at Time of IUD Insertion Using a 10 cm (100 mm) Visual Analog Scale (VAS)
Pain at time of IUD insertion will be measured immediately upon completion of IUD insertion using a 100 mm visual analog scale (VAS). Patients are presented with a 100 mm line. On one end of the line, the anchor is "0 = No pain". On the opposite end of the line, the anchor is "10 = worst pain possible". Subjects are asked: "Where 0 is no pain and 10 is the worst pain possible, please record your pain on the scale below." Research staff measure the distance between the "0 = No pain" anchor and the mark made by the patient (in mm) to score the measure.
Time frame: Immediately after IUD insertion is complete

Secondary outcomes

Pain With Tenaculum Placement Using a 10cm (100 mm) Visual Analog Scale (VAS)
Pain with tenaculum placement will be measured immediately after tenaculum is placed on the cervix using a 10cm (100 mm) visual analog scale (VAS). Patients are presented with a 100 mm line. On one end of the line, the anchor is "0 = No pain". On the opposite end of the line, the anchor is "10 = worst pain possible". Subjects are asked: "Where 0 is no pain and 10 is the worst pain possible, please record your pain on the scale below." Research staff measure the distance between the "0 = No pain" anchor and the mark made by the patient (in mm) to score the measure.
Time frame: Immediately after tenaculum is placed on cervix
Pain With Uterine Sounding Using a 10cm (100 mm) Visual Analog Scale (VAS)
Pain with uterine sounding will be measured immediately after uterine sounding using a 10cm (100 mm) visual analog scale (VAS). Patients are presented with a 100 mm line. On one end of the line, the anchor is "0 = No pain". On the opposite end of the line, the anchor is "10 = worst pain possible". Subjects are asked: "Where 0 is no pain and 10 is the worst pain possible, please record your pain on the scale below." Research staff measure the distance between the "0 = No pain" anchor and the mark made by the patient (in mm) to score the measure.
Time frame: Immediately after uterine sounding
Pain 5 Minutes After IUD Insertion Using a 10cm (100 mm) Visual Analog Scale (VAS)
Pain 5 minutes after IUD insertion will occur five minutes after IUD insertion is complete using a 10cm (100 mm) visual analog scale (VAS). Patients are presented with a 100 mm line. On one end of the line, the anchor is "0 = No pain". On the opposite end of the line, the anchor is "10 = worst pain possible". Subjects are asked: "Where 0 is no pain and 10 is the worst pain possible, please record your pain on the scale below." Research staff measure the distance between the "0 = No pain" anchor and the mark made by the patient (in mm) to score the measure.
Time frame: Five minutes after IUD insertion is complete
Pain 15 Minutes After IUD Insertion Using a 10cm (100 mm) Visual Analog Scale (VAS)
Pain 15 minutes after IUD insertion will occur 15 minutes after IUD insertion is complete using a 10cm (100 mm) visual analog scale (VAS). Patients are presented with a 100 mm line. On one end of the line, the anchor is "0 = No pain". On the opposite end of the line, the anchor is "10 = worst pain possible". Subjects are asked: "Where 0 is no pain and 10 is the worst pain possible, please record your pain on the scale below." Research staff measure the distance between the "0 = No pain" anchor and the mark made by the patient (in mm) to score the measure.
Time frame: Fifteen minutes after IUD insertion is complete

Results

Posted Jun 22, 2017

Participant flow

Participant flow — Overall Study
Milestone	Naproxen Sodium	Placebo
Started	59	60
Completed	58	60
Not completed	1	0
Withdrew: Patient did not receive iud	1	0

Outcome measures

PrimaryPain at Time of IUD Insertion Using a 10 cm (100 mm) Visual Analog Scale (VAS)

Pain at time of IUD insertion will be measured immediately upon completion of IUD insertion using a 100 mm visual analog scale (VAS). Patients are presented with a 100 mm line. On one end of the line, the anchor is "0 = No pain". On the opposite end of the line, the anchor is "10 = worst pain possible". Subjects are asked: "Where 0 is no pain and 10 is the worst pain possible, please record your pain on the scale below." Research staff measure the distance between the "0 = No pain" anchor and the mark made by the patient (in mm) to score the measure.

Time frame:: Immediately after IUD insertion is complete
Reported as:: Median · units on a scale

Pain at Time of IUD Insertion Using a 10 cm (100 mm) Visual Analog Scale (VAS)
units on a scale	Naproxen Sodium	Placebo
Pain at Time of IUD Insertion Using a 10 cm (100 mm) Visual Analog Scale (VAS)	69 (52.5 to 80.5)	66 (50 to 82)

SecondaryPain With Tenaculum Placement Using a 10cm (100 mm) Visual Analog Scale (VAS)

Pain with tenaculum placement will be measured immediately after tenaculum is placed on the cervix using a 10cm (100 mm) visual analog scale (VAS). Patients are presented with a 100 mm line. On one end of the line, the anchor is "0 = No pain". On the opposite end of the line, the anchor is "10 = worst pain possible". Subjects are asked: "Where 0 is no pain and 10 is the worst pain possible, please record your pain on the scale below." Research staff measure the distance between the "0 = No pain" anchor and the mark made by the patient (in mm) to score the measure.

Time frame:: Immediately after tenaculum is placed on cervix
Reported as:: Median · units on a scale

Pain With Tenaculum Placement Using a 10cm (100 mm) Visual Analog Scale (VAS)
units on a scale	Naproxen Sodium	Placebo
Pain With Tenaculum Placement Using a 10cm (100 mm) Visual Analog Scale (VAS)	37.3 (20 to 55)	31.8 (17 to 60)

SecondaryPain With Uterine Sounding Using a 10cm (100 mm) Visual Analog Scale (VAS)

Pain with uterine sounding will be measured immediately after uterine sounding using a 10cm (100 mm) visual analog scale (VAS). Patients are presented with a 100 mm line. On one end of the line, the anchor is "0 = No pain". On the opposite end of the line, the anchor is "10 = worst pain possible". Subjects are asked: "Where 0 is no pain and 10 is the worst pain possible, please record your pain on the scale below." Research staff measure the distance between the "0 = No pain" anchor and the mark made by the patient (in mm) to score the measure.

Time frame:: Immediately after uterine sounding
Reported as:: Median · units on a scale

Pain With Uterine Sounding Using a 10cm (100 mm) Visual Analog Scale (VAS)
units on a scale	Naproxen Sodium	Placebo
Pain With Uterine Sounding Using a 10cm (100 mm) Visual Analog Scale (VAS)	59.8 (45 to 75)	58 (39 to 68)

SecondaryPain 5 Minutes After IUD Insertion Using a 10cm (100 mm) Visual Analog Scale (VAS)

Pain 5 minutes after IUD insertion will occur five minutes after IUD insertion is complete using a 10cm (100 mm) visual analog scale (VAS). Patients are presented with a 100 mm line. On one end of the line, the anchor is "0 = No pain". On the opposite end of the line, the anchor is "10 = worst pain possible". Subjects are asked: "Where 0 is no pain and 10 is the worst pain possible, please record your pain on the scale below." Research staff measure the distance between the "0 = No pain" anchor and the mark made by the patient (in mm) to score the measure.

Time frame:: Five minutes after IUD insertion is complete
Reported as:: Median · units on a scale

Pain 5 Minutes After IUD Insertion Using a 10cm (100 mm) Visual Analog Scale (VAS)
units on a scale	Naproxen Sodium	Placebo
Pain 5 Minutes After IUD Insertion Using a 10cm (100 mm) Visual Analog Scale (VAS)	16.5 (4.5 to 29)	26 (14 to 39)

SecondaryPain 15 Minutes After IUD Insertion Using a 10cm (100 mm) Visual Analog Scale (VAS)

Pain 15 minutes after IUD insertion will occur 15 minutes after IUD insertion is complete using a 10cm (100 mm) visual analog scale (VAS). Patients are presented with a 100 mm line. On one end of the line, the anchor is "0 = No pain". On the opposite end of the line, the anchor is "10 = worst pain possible". Subjects are asked: "Where 0 is no pain and 10 is the worst pain possible, please record your pain on the scale below." Research staff measure the distance between the "0 = No pain" anchor and the mark made by the patient (in mm) to score the measure.

Time frame:: Fifteen minutes after IUD insertion is complete
Reported as:: Median · units on a scale

Pain 15 Minutes After IUD Insertion Using a 10cm (100 mm) Visual Analog Scale (VAS)
units on a scale	Naproxen Sodium	Placebo
Pain 15 Minutes After IUD Insertion Using a 10cm (100 mm) Visual Analog Scale (VAS)	12.8 (5 to 31)	24 (11 to 38)

Adverse events

Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Naproxen Sodium	—	0/58 (0%)	2/58 (3.4%)
Placebo	—	0/60 (0%)	3/60 (5%)

Most frequent other events

Most frequent other events
Event	Naproxen Sodium	Placebo
Vasovagal episodeGeneral disorders	2/58	3/60

Baseline characteristics

Age, Continuous
Age, Continuous(years)	Naproxen Sodium	Placebo	Total
Mean	23.2 ± 3.9	24.3 ± 4.2	23.86 ± 4.1

Sex: Female, Male
Sex: Female, Male(Participants)	Naproxen Sodium	Placebo	Total
Female	58	60	118
Male	0	0	0

Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)	Naproxen Sodium	Placebo	Total
African American or black	1	1	2
White or European American	43	50	93
Asian	6	6	12
Multiracial	3	2	5
Other	5	1	6

Marital status
Marital status(Participants)	Naproxen Sodium	Placebo	Total
Married	3	1	4
Single	51	54	105
Other	4	5	9

Highest level of education
Highest level of education(Participants)	Naproxen Sodium	Placebo	Total
High school or high school equivalency	5	4	9
Some college or 2 year college	25	23	48
4 year college or Bachelor's degree	23	22	45
Graduate or professional school	5	9	14
Other	0	2	2

Diagnosed with chronic pain condition (yes)
Diagnosed with chronic pain condition (yes)(Participants)	Naproxen Sodium	Placebo	Total
Count of participants	2	1	3

Diagnosed with depression (yes)
Diagnosed with depression (yes)(Participants)	Naproxen Sodium	Placebo	Total
Count of participants	14	11	25

Baseline stress, self-report
Baseline stress, self-report(units on a scale)	Naproxen Sodium	Placebo	Total
Median	4 (3 to 6)	4 (3 to 6)	4 (3 to 6)

4 further baseline measures are reported on the registry.

Study locations

1 site

Planned Parenthood League of Massachusetts
Boston, Massachusetts 02215, United States

References and documents

Publications

Ngo LL, Braaten KP, Eichen E, Fortin J, Maurer R, Goldberg AB. Naproxen Sodium for Pain Control With Intrauterine Device Insertion: A Randomized Controlled Trial. Obstet Gynecol. 2016 Dec;128(6):1306-1313. doi: 10.1097/AOG.0000000000001746. PubMed 27824753 ↗

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jun 22, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02388191
Lead sponsor: Planned Parenthood League of Massachusetts
Responsible party: Sponsor
First posted: Mar 13, 2015
Start date: Apr 2015
Primary completion: Apr 2016
Completion: Apr 2016
Results posted: Jun 22, 2017
Last update: Jun 22, 2017

Study contacts

Principal Investigator, MD, MPH

principal investigator · PPLM

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jun 2017. You cannot join it, but the record below documents what was studied.

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