Menorrhagia, Heavy Menstrual Bleeding
Conditions
Keywords
Heavy Menstrual Bleeding, Menorrhagia
Brief summary
The purpose of this study is to determine whether XP12B is effective and safe in the treatment of women with heavy menstrual bleeding associated with menorrhagia.
Interventions
3900 mg/Day
DRUGPlacebo tablets
Sponsors
Ferring Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 49 Years
Healthy volunteers
No
Inclusion criteria
* Women with menorrhagia * 18-49 years of age * Regularly occurring menstrual periods
Exclusion criteria
* History or presence of clinically significant disease or abnormalities that may confound the study * History of bilateral oophorectomy or hysterectomy * Hormone therapy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Reduction From Baseline in Menstrual Blood Loss (MBL) | Baseline MBL over 6 menstrual cycles | reduction of menstrual blood loss in mL |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Reported Outcome Measure of Limitations in Social or Leisure Activities Associated With Heavy Menstrual Bleeding | Change from Baseline scores over 6 menstrual cycles | A positive unit change mean relects an improvement from baseline. Patient reported outcome scores had the following response categories: 1=not limited at all; 2=slightly limited; 3=moderately limited; 4=quite a bit limited; and 5=extremely limited |
| Patient Reported Outcome Measure of Limitations in Physical Activities Associated With Heavy Menstrual Bleeding | Change from Baseline scores over 6 menstrual cycles | A positive unit change mean relects an improvement from baseline. Patient reported outcome scores had the following response categories: 1=not limited at all; 2=slightly limited; 3=moderately limited; 4=quite a bit limited; and 5=extremely limited |
| Responder Analysis - Reduction in Large Stains | Reduction from Baseline over 6 menstrual cycles | Percentage of subjects who experienced a reduction from baseline in the frequency of large stains |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 3900 mg/Day Two 650 mg Lysteda (tranexamic acid) tablets taken 3 times daily (3900 mg/day) for a maximum of 5 days during monthly menstruation | 117 |
| Placebo Two placebo tablets taken 3 times daily for a maximum of 5 days during monthly menstruation | 72 |
| Total | 189 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 3 | 3 |
| Overall Study | Lack of Efficacy | 0 | 2 |
| Overall Study | Lost to Follow-up | 10 | 6 |
| Overall Study | Other Event | 8 | 1 |
| Overall Study | Protocol Violation | 2 | 5 |
| Overall Study | Withdrawal by Subject | 6 | 2 |
Baseline characteristics
| Characteristic | 3900 mg/Day | Placebo | Total |
|---|---|---|---|
| Age Continuous | 39 years STANDARD_DEVIATION 6 | 39 years STANDARD_DEVIATION 7 | 39 years STANDARD_DEVIATION 7 |
| Sex: Female, Male Female | 117 Participants | 72 Participants | 189 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 111 / 117 | 66 / 72 |
| serious Total, serious adverse events | 2 / 117 | 3 / 72 |
Outcome results
Primary
Mean Reduction From Baseline in Menstrual Blood Loss (MBL)
reduction of menstrual blood loss in mL
Time frame: Baseline MBL over 6 menstrual cycles
Population: modified intent to treat population
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| 3900 mg/Day | Mean Reduction From Baseline in Menstrual Blood Loss (MBL) | 66 mL | Standard Deviation 64 |
| Placebo | Mean Reduction From Baseline in Menstrual Blood Loss (MBL) | 18 mL | Standard Deviation 36 |
Secondary
Patient Reported Outcome Measure of Limitations in Physical Activities Associated With Heavy Menstrual Bleeding
A positive unit change mean relects an improvement from baseline. Patient reported outcome scores had the following response categories: 1=not limited at all; 2=slightly limited; 3=moderately limited; 4=quite a bit limited; and 5=extremely limited
Time frame: Change from Baseline scores over 6 menstrual cycles
Population: modified intent to treat population (reflects those subjects who met the criteria for the primary efficacy analysis)
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| 3900 mg/Day | Patient Reported Outcome Measure of Limitations in Physical Activities Associated With Heavy Menstrual Bleeding | 0.9 units on a scale | Standard Deviation 0.9 |
| Placebo | Patient Reported Outcome Measure of Limitations in Physical Activities Associated With Heavy Menstrual Bleeding | 0.4 units on a scale | Standard Deviation 0.9 |
Secondary
Patient Reported Outcome Measure of Limitations in Social or Leisure Activities Associated With Heavy Menstrual Bleeding
A positive unit change mean relects an improvement from baseline. Patient reported outcome scores had the following response categories: 1=not limited at all; 2=slightly limited; 3=moderately limited; 4=quite a bit limited; and 5=extremely limited
Time frame: Change from Baseline scores over 6 menstrual cycles
Population: modified intent to treat population (reflects those subjects who met the criteria for the primary efficacy analysis)
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| 3900 mg/Day | Patient Reported Outcome Measure of Limitations in Social or Leisure Activities Associated With Heavy Menstrual Bleeding | 0.9 units on a scale | Standard Deviation 0.8 |
| Placebo | Patient Reported Outcome Measure of Limitations in Social or Leisure Activities Associated With Heavy Menstrual Bleeding | 0.4 units on a scale | Standard Deviation 0.4 |
Secondary
Responder Analysis - Reduction in Large Stains
Percentage of subjects who experienced a reduction from baseline in the frequency of large stains
Time frame: Reduction from Baseline over 6 menstrual cycles
Population: modified intent to treat population (reflects those subjects who met the criteria for the primary efficacy analysis)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 3900 mg/Day | Responder Analysis - Reduction in Large Stains | 57 percentage of subjects |
| Placebo | Responder Analysis - Reduction in Large Stains | 51 percentage of subjects |