Copper IUD Treatment Observation Study

NCT ID: NCT02519231

Last Updated: 2020-10-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-02-29
• Study Completion Date: 2017-11-30

Brief Summary

Studies indicate that bleeding irregularities and dysmenorrhea are common reasons for copper IUD method discontinuation. Some evidence suggests that non-steroidal anti-inflammatory medications (NSAIDs) can help improve bleeding during Cu-IUD use. However, these studies did not examine NSAID use with the TCu380A specifically, nor did they evaluate readily available NSAIDs such as over-the-counter naproxen. For this reason, the investigators propose a pilot trial in which new TCu380A users complaining of heavy or prolonged menstrual bleeding or spotting after 1 month of use are randomized to naproxen or placebo to be taken the first 7 days of menstruation for three consecutive cycles, and then observed for one cycle without treatment.

Detailed Description

The Copper IUD (Cu-IUD) is the most widely used IUD in the world, and its use in the United States (US) is on the rise. The Cu-IUD is considered one of the most effective contraception methods, being as effective as permanent sterilization but having the convenience of being reversible should a woman decide to conceive.2 The Copper 380A (TCu380A) is the only Cu-IUD available in the US; of all Cu-IUDs, the TCu380A is considered the most effective. Despite its increasing popularity in the US, studies indicate that bleeding irregularities and dysmenorrhea are common reasons for method discontinuation. Some evidence suggests that non-steroidal anti-inflammatory medications (NSAIDs) can help improve bleeding during Cu-IUD use. However, these studies did not examine NSAID use with the TCu380A specifically, nor did they evaluate readily available NSAIDs such as over-the-counter naproxen. For this reason, the investigators propose a pilot trial in which new TCu380A users complaining of heavy or prolonged menstrual bleeding or spotting after 1 month of use are randomized to naproxen or placebo to be taken the first 7 days of menstruation for three consecutive cycles, and then observed for one cycle without treatment. The number of bleeding/spotting days will be compared using Student t-test. In addition to assessing how well naproxen reduces incidence and amount of bleeding, the investigators will also assess the use of naproxen and TCu380A on quality of life, sexual function, method satisfaction, menstrual pain, and adverse events. By measuring these variables, the investigators will assess both positive and negative consequences of TCu380A use, ensuring that harm does not outweigh benefits.

Conditions

Menorrhagia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Treatment

This study arm includes naproxen as potential treatment for heavy or prolonged bleeding or dysmenorrhea may provide useful preliminary data for a larger, adequately powered placebo-controlled comparative trial testing additional promising treatments, such as tranexamic acid.

Group Type: ACTIVE_COMPARATOR

Naproxen

Intervention Type: DRUG

Naproxen 440mg 1x pid

placebo

This study arm includes capsules that are exactly like the active treatment medication (naproxen), but there is no active treatment medication in these tablets.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo tablet 440mg 1x pid

Interventions

Naproxen

Naproxen 440mg 1x pid

Intervention Type: DRUG

Placebo

Placebo tablet 440mg 1x pid

Intervention Type: DRUG

Other Intervention Names

Intervention; Control

Eligibility Criteria

Exclusion Criteria

• Requesting to have TCu380A IUD inserted as contraceptive method.
• English-speaking.
• Regular menstrual cycles ranging 21-35 days apart.
• Generally healthy.
• Willing to attend a 4- to 6-week follow-up visit and complete surveys.

• Known or suspected pregnancy.

• Contraindications to NSAID use. This includes underlying heart failure, chronic renal disease, chronic liver disease, peptic ulcer disease, or history of upper gastrointestinal bleed, and allergy to NSAIDs.
• Current regular use of a NSAID.
• Unwilling to avoid use of NSAIDs (except for study medication) for the duration of the study.
• Current diagnosis of menorrhagia, metrorrhagia, symptomatic uterine fibroids, or endometrial polyps.
• Use of depot medroxyprogesterone acetate (DMPA) or levonorgestrel-releasing intrauterine device (LNG IUD) within the previous 3 months.
• Postpartum in the past 4 weeks. The average day in which non-breastfeeding postpartum women ovulate is 25 days after birth, indicating that menstrual cycles can resume after the 4th postpartum week.
• Existing medical condition for which placement of TCu380A IUD is a contraindication according to the Centers for Disease Control and Prevention Medical Eligibility Criteria (MEC 4 medical conditions; see Appendix A).
• Currently breastfeeding.
• Previous use of the TCu380A.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 49 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Cook County Hospital

OTHER

Sponsor Role: collaborator

Teva Pharmaceuticals USA

INDUSTRY

Sponsor Role: collaborator

University of Washington

OTHER

Sponsor Role: lead

Responsible Party

Emily Godfrey

Associate Professor of Family Medicine and OB/GYN

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Emily Godfrey, MD,MPH

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Locations

John H Stroger Jr Hospital of Cook County

Chicago, Illinois, United States

Harborview Medical Center

Seattle, Washington, United States

UW Neighborhood Clinic Northgate

Seattle, Washington, United States

Hall Health Center

Seattle, Washington, United States

University of Washington Medical Centers

Seattle, Washington, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

STUDY00000323

Identifier Type: -

Identifier Source: org_study_id