A Phase 4 interventional study of Naproxen and Placebo in Menorrhagia, sponsored by University of Washington. Completed at 5 sites in United States. Open to female participants aged 18 Years to 49 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-10-14.
Sponsored by University of Washington · Phase 4, Interventional, and Treatment
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.
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.
182 studies on the registry are indexed under Menorrhagia; 33 are open to participants now.
This study's enrollment of 34 is below the median of 100 across 133 interventional studies indexed under Menorrhagia.
Browse Menorrhagia studies →University of Washington is the lead sponsor of 1,397 studies on the registry; 225 are open to participants now.
Of its 154 completed or terminated interventional studies of FDA-regulated products, 132 (86%) have results posted.
Counted across the registry records on this site, refreshed daily.
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).
Exclusion Criteria:
Known or suspected pregnancy.
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
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
Naproxen 440mg 1x pid
Also known as: Intervention
Placebo tablet 440mg 1x pid
Also known as: Control
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.
Time frame: 4 months
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.
Time frame: 4 months
Between February 2016 to May 2017, 34 women enrolled into the study, of whom 28 were randomized.
| Milestone | Treatment | Placebo |
|---|---|---|
| Started | 14 | 14 |
| Completed | 12 | 8 |
| Not completed | 2 | 6 |
| Withdrew: Lost to follow-up | 2 | 5 |
| Withdrew: Withdrawal by subject | 0 | 1 |
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.
| days | Treatment | Placebo |
|---|---|---|
| Bleeding or spotting days first 84 days | 29.2 ± 4.5 | 23.0 ± 2.8 |
| Bleeding or spotting days last 28 days | 9.3 ± 1.9 | 9.6 ± 0.9 |
| Bleeding only days first 84 days | 15.7 ± 2.1 | 15.5 ± 1.8 |
| Bleeding only days last 28 days | 4.8 ± 1.0 | 6.6 ± 1.2 |
| Spotting only days first 84 days | 13.5 ± 5.1 | 7.5 ± 1.7 |
| Spotting only days last 28 days | 4.5 ± 2.0 | 3.0 ± 0.8 |
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.
| Participants | Treatment | Placebo |
|---|---|---|
| Month 1 : Moderate heavy or heavy bleeding | 7 | 7 |
| Month 1 : Menstrual bleeding length 7+ days | 8 | 5 |
| Month 1 : Often/always cramping | 1 | 5 |
| Month 1 : Unexpected bleeding | 6 | 5 |
| Month 2 : Moderate heavy or heavy bleeding | 4 | 8 |
| Month 2 : Menstrual bleeding length 7+ days | 8 | 5 |
| Month 2 : Often/always cramping | 1 | 1 |
| Month 2 : Unexpected bleeding | 7 | 7 |
| Month 3 : Moderate heavy or heavy bleeding | 6 | 7 |
| Month 3 : Menstrual bleeding length 7+ days | 6 | 5 |
| Month 3 : Often/always cramping | 1 | 1 |
| Month 3 : Unexpected bleeding | 1 | 5 |
| Month 4 : Moderate heavy or heavy bleeding | 7 | 5 |
| Month 4 : Menstrual bleeding length 7+ days | 6 | 6 |
| Month 4 : Often/always cramping | 3 | 1 |
| Month 4 : Unexpected bleeding | 5 | 6 |
Collected over 4 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Treatment | 0/13 (0%) | 0/13 (0%) | 0/13 (0%) |
| Placebo | 0/14 (0%) | 0/14 (0%) | 0/14 (0%) |
There were no significant differences of baseline characteristics between the groups. The majority participating in the study had a mean age of 29 years, were white, had Bachelor's degree or higher, married/living with their partner and nulliparous.
| Age, Categorical(Participants) | Treatment | Placebo | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 14 | 14 | 28 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | Treatment | Placebo | Total |
|---|---|---|---|
| Mean | 29.3 (23 to 35) | 29.3 (21 to 42) | 29.3 (21 to 42) |
| Sex: Female, Male(Participants) | Treatment | Placebo | Total |
|---|---|---|---|
| Female | 14 | 14 | 28 |
| Male | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Treatment | Placebo | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 1 | 2 | 3 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 12 | 11 | 23 |
| More than one race | 1 | 1 | 2 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Treatment | Placebo | Total |
|---|---|---|---|
| United States | 14 | 14 | 28 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — All datasets used and analysed during the current study are available from the corresponding author on reasonable request
Supporting information: Study protocol, Icf
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