Dysmenorrhea
Conditions
Keywords
cyclic pelvic pain, dysmenorrhea, oral contraceptives
Brief summary
This study is being conducted to evaluate the effects of treatment with Seasonique an extended-regimen oral contraceptive that utilizes low dose ethinyl estradiol during the typical hormone-free interval. Patients will receive 13 weeks of treatment with the option to extend blinded therapy for an additional 13 weeks. The overall study duration will be 6-9 months. Patients will be required to record menstrual pain in a daily diary.
Interventions
1 tablet daily by mouth
DRUGPlacebo tablet
1 tablet daily by mouth
Sponsors
Duramed Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
No minimum to 17 Years
Healthy volunteers
No
Inclusion criteria
* Sexually naïve and agree to abstain from sex during the study * Moderate to severe menstrual-related pelvic pain * Regular spontaneous menstrual cycles
Exclusion criteria
* Any contraindication to the use of oral contraceptives * Treatment with an oral contraceptive within the previous 3 months * Previous treatment failure with an extended oral contraceptive regimen
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change in Average Severity for Abdominal/Pelvic Pain | Baseline to end of 13-week treatment period | Defined as the sum of pain scores divided by the total number of days in which the subject experienced abdominal/pelvic pain, from baseline to Week 13 The severity of the pain was assessed using a 4-points scale (0 = None, 1 = Mild, 2 = Moderate, 3 = Severe) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Maximum Severity of Abdominal/Pelvic Pain | Baseline to end of Week 13 | Maximum pain severity score was calculated by identifying each subject's maximum recorded pain severity from baseline to end of Week 13. The severity of the pain was assessed using a 4-points scale (0 = None, 1 = Mild, 2 = Moderate, 3 = Severe) |
| Incidence of Menstrual Bleeding and /or Spotting | Baseline to end of Week 13 | — |
| Number of Days Missed From School/Work or Other Activities | 13-week treatment period | — |
| Analgesic Use | 13-week treatment period | number of days analgesic (pain) medication was used over the 13 week treatment period |
Countries
United States
Participant flow
Pre-assignment details
A total of 123 subjects were screened, of which 95 subjects were randomized. Of those randomized, 95 subjects took at lease 1 dose of study medication.
Participants by arm
| Arm | Count |
|---|---|
| Seasonique Seasonique
, 1 tablet daily | 47 |
| Placebo Placebo, 1 tablet daily | 48 |
| Total | 95 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 3 | 1 |
| Overall Study | Lost to Follow-up | 2 | 2 |
| Overall Study | Protocol Violation | 2 | 3 |
| Overall Study | Subject Pregnant | 1 | 1 |
| Overall Study | Withdrawal by Subject | 3 | 1 |
Baseline characteristics
| Characteristic | Seasonique | Placebo | Total |
|---|---|---|---|
| Age, Continuous | 15.5 Years STANDARD_DEVIATION 1.23 | 15.4 Years STANDARD_DEVIATION 1.36 | 15.5 Years STANDARD_DEVIATION 1.29 |
| Body Mass Index | 24.8 kg/m^2 STANDARD_DEVIATION 6.88 | 26.4 kg/m^2 STANDARD_DEVIATION 7.16 | 25.6 kg/m^2 STANDARD_DEVIATION 7.04 |
| Race/Ethnicity, Customized African-American | 18 participants | 17 participants | 35 participants |
| Race/Ethnicity, Customized Caucasian | 29 participants | 27 participants | 56 participants |
| Race/Ethnicity, Customized Hispanic | 0 participants | 3 participants | 3 participants |
| Race/Ethnicity, Customized Other | 0 participants | 1 participants | 1 participants |
| Sex: Female, Male Female | 47 Participants | 48 Participants | 95 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 | 47 / 47 | 17 / 48 |
| serious Total, serious adverse events | 2 / 47 | 0 / 48 |
Outcome results
Primary
Mean Change in Average Severity for Abdominal/Pelvic Pain
Defined as the sum of pain scores divided by the total number of days in which the subject experienced abdominal/pelvic pain, from baseline to Week 13 The severity of the pain was assessed using a 4-points scale (0 = None, 1 = Mild, 2 = Moderate, 3 = Severe)
Time frame: Baseline to end of 13-week treatment period
Population: Complete Cohort: consisted of all randomized subjects who completed the full term of study participation (13 weeks) and who had no recorded protocol violations that would have excluded the from analysis.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Seasonique | Mean Change in Average Severity for Abdominal/Pelvic Pain | -0.45 units on a scale | Standard Error 0.06 |
| Placebo | Mean Change in Average Severity for Abdominal/Pelvic Pain | -0.19 units on a scale | Standard Error 0.058 |
Secondary
Analgesic Use
number of days analgesic (pain) medication was used over the 13 week treatment period
Time frame: 13-week treatment period
Population: Complete Cohort: consisted of all randomized subjects who completed the full term of study participation (13 weeks) and who had no recorded protocol violations that would have excluded the from analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Seasonique | Analgesic Use | 2.92 Days Analgesic was used over 13 weeks | Standard Deviation 3.281 |
| Placebo | Analgesic Use | 4.03 Days Analgesic was used over 13 weeks | Standard Deviation 5.356 |
Secondary
Change From Baseline in Maximum Severity of Abdominal/Pelvic Pain
Maximum pain severity score was calculated by identifying each subject's maximum recorded pain severity from baseline to end of Week 13. The severity of the pain was assessed using a 4-points scale (0 = None, 1 = Mild, 2 = Moderate, 3 = Severe)
Time frame: Baseline to end of Week 13
Population: Complete Cohort: consisted of all randomized subjects who completed the full term of study participation (13 weeks) and who had no recorded protocol violations that would have excluded the from analysis.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Seasonique | Change From Baseline in Maximum Severity of Abdominal/Pelvic Pain | -0.62 units on a scale | Standard Error 0.12 |
| Placebo | Change From Baseline in Maximum Severity of Abdominal/Pelvic Pain | -0.17 units on a scale | Standard Error 0.117 |
Secondary
Incidence of Menstrual Bleeding and /or Spotting
Time frame: Baseline to end of Week 13
Population: Complete Cohort: consisted of all randomized subjects who completed the full term of study participation (13 weeks) and who had no recorded protocol violations that would have excluded the from analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Seasonique | Incidence of Menstrual Bleeding and /or Spotting | 28.389 Days of bleeding/spotting over 13 weeks | Standard Deviation 14.705 |
| Placebo | Incidence of Menstrual Bleeding and /or Spotting | 18.000 Days of bleeding/spotting over 13 weeks | Standard Deviation 6.026 |
Secondary
Number of Days Missed From School/Work or Other Activities
Time frame: 13-week treatment period
Population: Complete Cohort: consisted of all randomized subjects who completed the full term of study participation (13 weeks) and who had no recorded protocol violations that would have excluded the from analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Seasonique | Number of Days Missed From School/Work or Other Activities | 0.83 Days | Standard Deviation 1.844 |
| Placebo | Number of Days Missed From School/Work or Other Activities | 2.75 Days | Standard Deviation 3.418 |