Copper IUD Treatment Observation Study

NCT02519231 | Completed Phase 4 Results

• 1 other identifier: STUDY00000323
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 5

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.

Conditions

Menorrhagia

Keywords

IUD; naproxen; bleeding

Outcome Measures

Primary Outcomes (1)

• Mean Days of Bleeding and Spotting, Spotting Only and Bleeding Only for the 84 Day Treatment Cycles and Last 28 Day Post-treatment Cycle

  Number of bleeding and spotting, spotting only and bleeding only days given as mean. We calculated the mean difference and 95% confidence interval between the two treatment groups and provided the p-value of means.

  4 months

Secondary Outcomes (1)

• Percentage Reporting Moderate-heavy/Heavy Menses, Often/Always Menstrual Cramping and 7 or More Days of Menstrual Bleeding for the 84-day Treatment Months and 28-day Post-treatment Month

  4 months

Study Arms (2)

Treatment

ACTIVE COMPARATOR

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.

Drug: Naproxen

placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Naproxen DRUG

Naproxen 440mg 1x pid

Also known as: Intervention

Treatment

Placebo DRUG

Placebo tablet 440mg 1x pid

Also known as: Control

placebo

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Washington: lead
• Cook County Hospital: collaborator
• Teva Pharmaceuticals USA: collaborator

Study Sites (5)

John H Stroger Jr Hospital of Cook County

Chicago, Illinois, 60612, United States

Location

Harborview Medical Center

Seattle, Washington, 98104, United States

Location

UW Neighborhood Clinic Northgate

Seattle, Washington, 98125, United States

Location

Hall Health Center

Seattle, Washington, 98195, United States

Location

University of Washington Medical Centers

Seattle, Washington, 98195, United States

Location

MeSH Terms

Conditions

Menorrhagia; Hemorrhage

Interventions

Naproxen; Methods

Condition Hierarchy (Ancestors)

Uterine Hemorrhage; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Menstruation Disturbances

Intervention Hierarchy (Ancestors)

Naphthaleneacetic Acids; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Investigative Techniques

Limitations and Caveats

(1) Small sample size, which did not provide sufficient power to detect differences between the groups; (2) Missing bleeding diaries of 40% of placebo users and 15% of naproxen users. Our findings should be interpreted with caution.

Results Point of Contact

• Title: Dr. Emily Godfrey
• Organization: University of Washington

godfreye@uw.edu

206.685.4895

Study Officials

• Emily Godfrey, MD,MPH

  University of Washington

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Family Medicine and OB/GYN

Study Record Dates

• First Submitted: June 5, 2015
• First Posted: August 10, 2015
• Study Start: February 1, 2016
• Primary Completion: November 1, 2017
• Study Completion: November 1, 2017
• Last Updated: October 14, 2020
• Results First Posted: August 19, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Until 12/2022

Locations

US (5)