A Phase 4 interventional study of Levonorgestrel IUS and Tranexamic Acid in Heavy Menstrual Bleeding, Menorrhagia and Uterine Fibroids, sponsored by Shannon K. Laughlin-Tommaso. Completed at 2 sites in United States. Open to female participants aged 25 Years to 50 Years. Per ClinicalTrials.gov, last updated 2021-12-08.
Sponsored by Shannon K. Laughlin-Tommaso · Phase 4, Interventional, and Treatment
Among 13 studies testing Tranexamic Acid in Menorrhagia — 2 open to participants now, 2 under way, none of them phase 3. Tranexamic Acid · Menorrhagia.
Among the 13 studies testing Tranexamic Acid in Menorrhagia, this one is the 12th largest by enrollment, is the only one that started in 2017, is one of 5 in phase 4, and was the 11th registered.
206 studies on the registry are indexed under Menorrhagia; 35 are open to participants now.
Browse Menorrhagia studies →2 of the 13 studies testing Tranexamic Acid in Menorrhagia are open now. Recruiting first, the newest first:
University of Health Sciences Lahore
Ages 18–39 · Women only
University Health Network, Toronto
Ages 18–99
Tranexamic Acid: first FDA approval 1986 (CYKLOKAPRON). What it is approved for, and how studies give it, is on its page →
Of the 23 Menorrhagia studies recruiting now, 4 (17%) set no upper age limit and 19 (83%) stop at 75 or younger; 5 take children under 18; 5 take healthy volunteers.
This study: 25 Years to 50 Years · female · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
13 studies; the count open now beside each. This study's row is marked.
First in 2005; this study’s year is marked. 1 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 18 is below the median of 95 across 149 interventional studies indexed under Menorrhagia.
Median enrollment 100 across the 13 interventional studies. Of the 10 that completed or were terminated, 9 (90%) have results posted.
This tab as a report to print or save as PDF → With an account.
5 of 13 have an industry lead sponsor. The 9 most frequent:
This is the only study on the registry with Shannon K. Laughlin-Tommaso as lead sponsor.
Shannon K. Laughlin-Tommaso has 1 study filed under Menorrhagia — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 13 studies testing Tranexamic Acid in Menorrhagia, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
This is a randomized controlled trial (RCT) to assess the comparative effectiveness of Levonorgestrel Intrauterine System (LNG-IUS) to Tranexamic Acid (TA) for the treatment of heavy menstrual bleeding (HMB) in women with clinically-significant fibroids.
Uterine fibroids are common and debilitating problem for some women. Nearly 60% of women with fibroids report that symptoms affect their quality of life and impede physical activity, and 24% report that fibroid symptoms prevent them from reaching their true potential at work. Heavy menstrual bleeding, the most common symptom of uterine fibroids, affects approximately 1.4 million women per year.
Medical therapy is the first line treatment for heavy menstrual bleeding, but further studies need to be done to prove the effectiveness of these treatments.
The goal of this study is to determine the effectiveness of non-estrogenic medical therapy in women with a range of fibroid sizes, locations, and number.
Two effective medical treatments for heavy menstrual bleeding have limited data in women with fibroids. The Levonorgestrel intrauterine system was FDA approved for the treatment of heavy menstrual bleeding in 2009 and is highly effective for decreasing menstrual bleeding, treating anemia and improving quality of life. Moreover, it can be used continuously for 5 years. Tranexamic Acid is widely used outside the U.S. and was also FDA approved for heavy menstrual bleeding in 2009. Tranexamic Acid reduces menstrual blood loss in 40% of women and improves quality of life. In women with fibroids, Tranexamic Acid has been shown to decrease heavy menstrual bleeding and cause necrosis of the fibroids, especially larger fibroids, which should improve its efficacy for women with fibroids.
This randomized controlled trial will assess the comparative effectiveness of Levonorgestrel intrauterine system to Tranexamic Acid for the treatment of heavy menstrual bleeding in women with uterine fibroids
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Levonorgestrel-releasing intrauterine system (Mirena) contains 52 mg of levonorgestrel, a progestin, and is intended to provide an initial release of approximately 20 mcg/day. Levonorgestrel intrauterine system is effective immediately upon placement in the uterus and can be kept in place for up to 5 years.
Drug: Levonorgestrel IUS
Tranexamic Acid (Lysteda) is an antifibrinolytic drug. Tranexamic Acid will be dosed at 1300mg by mouth three times a day at the start of menses and used during the days that bleeding is heaviest (not to exceed 5 days per menstrual cycle).
Drug: Tranexamic Acid
LNG-IUS was FDA-approved for the treatment of heavy menstrual bleeding in 2009 and previously for contraception in 2000. The LNG-IUS is a T-shaped device with a polyethylene body containing a hormone reservoir, holding a total of 52 mg of levonorgestrel. LNG-IUS initially releases 20 micrograms of the progestin per day, which decreases to less than half that amount after 5 years of use. The levonorgestrel causes stromal pseudodecidualization, decreases endometrial thickness, and lowers uterine vascular density.
Also known as: Mirena IUS
Tranexamic Acid was FDA-approved for the treatment of heavy menstrual bleeding in 2009. Tranexamic Acid is a plasminogen-activator inhibitor that blocks fibrinolysis and reduces plasmin activity. A special formulation was designed for the treatment of heavy menstrual bleeding that reduces gastrointestinal side effects, brand name Lysteda which will be prescribed as 1300 mg to be taken three times per day for up to 5 days of the menstrual period.
Also known as: Lysteda
Change in Self-Reported Menorrhagia Scores
The Menorrhagia Multi-Attribute Scale (MMAS) questionnaire captures the subjective consequences of menorrhagia on six domains: practical difficulties; social life; psychological wellbeing; physical health; work routine; and family life. Each of the six domains has four statements that represent four levels of response. Respondents indicate the statement that best matches their feelings for each domain. The statement scores derive from a weighting of the domains and a weighting of the statements in level of severity by women in the original study. Scores range from 0 (worst possible state in all domains) to 100 (best possible state in all domains).
Time frame: Baseline, 3 months
Number of Participants to Complete Study
Total number of study participants to complete assigned treatment.
Time frame: 9 months
Change in Pain Score
Pain will be measured by a 10 cm visual analog scale (VAS) which uses a 100 point score, with 0 indicating no pain and 100 indicating worst pain ever. Change was determine by subtracting the 3 month score from baseline, a negative score indicates a decrease in pain.
Time frame: Baseline, 3 months
Change in Quality of Life
Measured by the RAND 36-Item Health Survey (Version 1.0). Physical function and mental well-being on scale range from 0-100. A high score defines a more favorable health state.
Time frame: Baseline, 3 months
Change in Quality of Life, as Measured by the Uterine Fibroid Symptom and Health-Related Quality of Life Questionnaire (UFS-QOL)
The Uterine Fibroid Symptom and Health Related Quality of Life (HRQL) Questionnaire consists of an 8-item symptom severity scale and 29 HRQL items comprising 6 domains: Concern, Activities, Energy/Mood, Control, Self-consciousness, and Sexual Function. All items are scored on a 5-point Likert scale, ranging from "not at all" to "a very great deal" for symptom severity items and "none of the time" to "all of the time" for the HRQL items. Symptom severity and HRQL subscale scores are summed and transformed into a 0-100 point scale. Higher HRQL subscale scores indicate better HRQL.
Time frame: Baseline, 3 months
Change in Symptoms, as Measured by the Uterine Fibroid Symptom and Health-Related Quality of Life Questionnaire (UFS-QOL)
The Uterine Fibroid Symptom and Health Related Quality of Life (HRQL) Questionnaire consists of an 8-item symptom severity scale and 29 HRQL items comprising 6 domains: Concern, Activities, Energy/Mood, Control, Self-consciousness, and Sexual Function. All items are scored on a 5-point Likert scale, ranging from "not at all" to "a very great deal" for symptom severity items and "none of the time" to "all of the time" for the HRQL items. Symptom severity and HRQL subscale scores are summed and transformed into a 0-100 point scale. Higher Symptom Severity scores indicating greater symptoms.
Time frame: Baseline, 3 months
Change in Fibroid Size
Fibroid size will be reported as millimeters (mm).
Time frame: 9 months
| Milestone | Levonorgestrel IUS | Tranexamic Acid |
|---|---|---|
| Started | 9 | 9 |
| Completed | 7 | 2 |
| Not completed | 2 | 7 |
| Withdrew: Iud expulsion | 1 | 0 |
| Withdrew: Lost to follow-up | 1 | 3 |
| Withdrew: Treatment change | 0 | 3 |
| Withdrew: Intolerance of medication | 0 | 1 |
The Menorrhagia Multi-Attribute Scale (MMAS) questionnaire captures the subjective consequences of menorrhagia on six domains: practical difficulties; social life; psychological wellbeing; physical health; work routine; and family life. Each of the six domains has four statements that represent four levels of response. Respondents indicate the statement that best matches their feelings for each domain. The statement scores derive from a weighting of the domains and a weighting of the statements in level of severity by women in the original study. Scores range from 0 (worst possible state in all domains) to 100 (best possible state in all domains).
| score on a scale | Levonorgestrel IUS | Tranexamic Acid |
|---|---|---|
| Change in Self-Reported Menorrhagia Scores | 59.1 (34.1 to 63.7) | 25.4 (12.5 to 40.3) |
Total number of study participants to complete assigned treatment.
| Participants | Levonorgestrel IUS | Tranexamic Acid |
|---|---|---|
| Number of Participants to Complete Study | 7 | 2 |
Pain will be measured by a 10 cm visual analog scale (VAS) which uses a 100 point score, with 0 indicating no pain and 100 indicating worst pain ever. Change was determine by subtracting the 3 month score from baseline, a negative score indicates a decrease in pain.
| units on a scale | Levonorgestrel IUS | Tranexamic Acid |
|---|---|---|
| Change in Pain Score | -57.5 (-60 to -30) | 0 (-63 to 20) |
Measured by the RAND 36-Item Health Survey (Version 1.0). Physical function and mental well-being on scale range from 0-100. A high score defines a more favorable health state.
| units on a scale | Levonorgestrel IUS | Tranexamic Acid |
|---|---|---|
| Physical Function | 11.1 (0.2 to 15.3) | 1.7 (-0.6 to 2.4) |
| Mental Well-being | -1.0 (-9.1 to 11.6) | 3.3 (2.4 to 11.1) |
The Uterine Fibroid Symptom and Health Related Quality of Life (HRQL) Questionnaire consists of an 8-item symptom severity scale and 29 HRQL items comprising 6 domains: Concern, Activities, Energy/Mood, Control, Self-consciousness, and Sexual Function. All items are scored on a 5-point Likert scale, ranging from "not at all" to "a very great deal" for symptom severity items and "none of the time" to "all of the time" for the HRQL items. Symptom severity and HRQL subscale scores are summed and transformed into a 0-100 point scale. Higher HRQL subscale scores indicate better HRQL.
| score on a scale | Levonorgestrel IUS | Tranexamic Acid |
|---|---|---|
| Change in Quality of Life, as Measured by the Uterine Fibroid Symptom and Health-Related Quality of Life Questionnaire (UFS-QOL) | 32.8 (24.1 to 58.6) | 21.6 (10.3 to 39.7) |
The Uterine Fibroid Symptom and Health Related Quality of Life (HRQL) Questionnaire consists of an 8-item symptom severity scale and 29 HRQL items comprising 6 domains: Concern, Activities, Energy/Mood, Control, Self-consciousness, and Sexual Function. All items are scored on a 5-point Likert scale, ranging from "not at all" to "a very great deal" for symptom severity items and "none of the time" to "all of the time" for the HRQL items. Symptom severity and HRQL subscale scores are summed and transformed into a 0-100 point scale. Higher Symptom Severity scores indicating greater symptoms.
| score on a scale | Levonorgestrel IUS | Tranexamic Acid |
|---|---|---|
| Change in Symptoms, as Measured by the Uterine Fibroid Symptom and Health-Related Quality of Life Questionnaire (UFS-QOL) | -28.1 (-37.5 to -21.9) | -15.6 (-21.9 to -3.1) |
Fibroid size will be reported as millimeters (mm).
| mm | Levonorgestrel IUS | Tranexamic Acid |
|---|---|---|
| Change in Fibroid Size | 3 (3 to 15) | 10.5 (3 to 18) |
Collected over Adverse events were collected from baseline to end of study participation for a total of 9 months on all participants.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Levonorgestrel IUS | 0/9 (0%) | 0/9 (0%) | 1/9 (11.1%) |
| Tranexamic Acid | 0/9 (0%) | 0/9 (0%) | 5/9 (55.6%) |
| Event | Levonorgestrel IUS | Tranexamic Acid |
|---|---|---|
| HeadacheNervous system disorders | 0/9 | 2/9 |
| Increased Vaginal BleedingReproductive system and breast disorders | 0/9 | 2/9 |
| Imbedded IUDReproductive system and breast disorders | 1/9 | 0/9 |
| Gastrointestinal DisturbanceGastrointestinal disorders | 0/9 | 1/9 |
| Age, Continuous(years) | Levonorgestrel IUS | Tranexamic Acid | Total |
|---|---|---|---|
| Mean | 42.5 ± 5.6 | 44.7 ± 4.8 | 43.6 ± 5.2 |
| Sex: Female, Male(Participants) | Levonorgestrel IUS | Tranexamic Acid | Total |
|---|---|---|---|
| Female | 9 | 9 | 18 |
| Male | 0 | 0 | 0 |
| Race/Ethnicity, Customized(Participants) | Levonorgestrel IUS | Tranexamic Acid | Total |
|---|---|---|---|
| Black or African American | 2 | 0 | 2 |
| White | 6 | 7 | 13 |
| Hispanic or Latino | 1 | 1 | 2 |
| Unknown | 0 | 1 | 1 |
| Region of Enrollment(participants) | Levonorgestrel IUS | Tranexamic Acid | Total |
|---|---|---|---|
| United States | 9 | 9 | 18 |
| Baseline hemoglobin(g/dL) | Levonorgestrel IUS | Tranexamic Acid | Total |
|---|---|---|---|
| Mean | 12.1 ± 1.7 | 12.22 ± 1.9 | 12.2 ± 1.8 |
| Baseline ferritin(mcg/L) | Levonorgestrel IUS | Tranexamic Acid | Total |
|---|---|---|---|
| Median | 6 (4 to 7) | 10 (5 to 56) | 7 (5 to 15) |
| Fibroid largest diameter(cm) | Levonorgestrel IUS | Tranexamic Acid | Total |
|---|---|---|---|
| Median | 3.6 (2.3 to 5.2) | 2.5 (1.8 to 5.0) | 3.5 (2.0 to 5.1) |
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Nov 2017 to primary completion in Dec 2020, 37 months.
Results were first posted in Dec 2021, 11 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Nov 2021. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Tranexamic Acid