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Copper IUD Treatment Observation Study (CITROS)

Primary Purpose

Menorrhagia

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Naproxen

Placebo

About this trial

This is an interventional treatment trial for Menorrhagia focused on measuring IUD, naproxen, bleeding

Eligibility Criteria

18 Years - 49 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

• Age ≥ 18 and < 49 years. We are including a wide range of ages because women of all ages request TCu380A. While we recognize that some women approaching menopause (median age = 51.4 years) may have changes in their baseline menstruation, we trust that clinicians enrolling the patients into the study will ensure that these women meet all inclusion (i.e., regular cycles) and exclusion criteria (i.e., do not have diagnosis of menorrhagia).
- 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.

Exclusion Criteria:

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.

Sites / Locations

John H Stroger Jr Hospital of Cook County
Harborview Medical Center
UW Neighborhood Clinic Northgate
Hall Health Center
University of Washington Medical Centers

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Treatment

placebo

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Percentage reporting moderate-heavy/heavy menses, often/always menstrual cramping and 7 or more days of menstrual bleeding during the first 84 days and the last 28 days. We also report % difference and p-value between the two treatment groups.

Full Information

NCT ID

NCT02519231

First Posted

June 5, 2015

Last Updated

September 23, 2020

Sponsor

University of Washington

Collaborators

Cook County Hospital, Teva Pharmaceuticals USA

1. Study Identification

Unique Protocol Identification Number

NCT02519231

Brief Title

Copper IUD Treatment Observation Study

Acronym

CITROS

Official Title

A Multi-Center, Double-Blinded, Randomized, Phase IV 6-Month Pilot Study to Compare Bleeding Patterns, Satisfaction and Quality of Life Among New Copper 380A IUD Users Treated With Naproxen Sodium (440mg Twice Daily) Versus Placebo

Study Type

Interventional

2. Study Status

Record Verification Date

September 2020

Overall Recruitment Status

Completed

Study Start Date

February 2016 (undefined)

Primary Completion Date

November 2017 (Actual)

Study Completion Date

November 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Washington

Collaborators

Cook County Hospital, Teva Pharmaceuticals USA

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Menorrhagia

Keywords

IUD, naproxen, bleeding

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

34 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Treatment

Arm Type

Active Comparator

Arm Description

Arm Title

placebo

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Naproxen

Other Intervention Name(s)

Intervention

Intervention Description

Naproxen 440mg 1x pid

Intervention Type

Drug

Intervention Name(s)

Placebo

Other Intervention Name(s)

Control

Intervention Description

Placebo tablet 440mg 1x pid

Primary Outcome Measure Information:

Title

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

Description

Time Frame

4 months

Secondary Outcome Measure Information:

Title

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

Description

Time Frame

4 months

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

49 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: • Age ≥ 18 and < 49 years. We are including a wide range of ages because women of all ages request TCu380A. While we recognize that some women approaching menopause (median age = 51.4 years) may have changes in their baseline menstruation, we trust that clinicians enrolling the patients into the study will ensure that these women meet all inclusion (i.e., regular cycles) and exclusion criteria (i.e., do not have diagnosis of menorrhagia). 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. Exclusion Criteria: 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Emily Godfrey, MD,MPH

Organizational Affiliation

University of Washington

Official's Role

Principal Investigator

Facility Information:

Facility Name

John H Stroger Jr Hospital of Cook County

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60612

Country

United States

Facility Name

Harborview Medical Center

City

Seattle

State/Province

Washington

ZIP/Postal Code

98104

Country

United States

Facility Name

UW Neighborhood Clinic Northgate

City

Seattle

State/Province

Washington

ZIP/Postal Code

98125

Country

United States

Facility Name

Hall Health Center

City

Seattle

State/Province

Washington

ZIP/Postal Code

98195

Country

United States

Facility Name

University of Washington Medical Centers

City

Seattle

State/Province

Washington

ZIP/Postal Code

98195

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

All datasets used and analysed during the current study are available from the corresponding author on reasonable request

IPD Sharing Time Frame

Until 12/2022

Learn more about this trial

Copper IUD Treatment Observation Study

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