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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 levonorgestrel/EE 0.15/0.03 and EE 0.01 mg tablet | Experimental |
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| 2 | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| levonorgestrel/EE 0.15/0.03 and EE 0.01 mg tablets | Drug | 1 tablet daily by mouth |
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| Measure | Description | Time Frame |
|---|---|---|
| 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") | Baseline to end of 13-week treatment period |
| Measure | Description | Time Frame |
|---|---|---|
| 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") | Baseline to end of Week 13 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duramed Investigational Site | Denver | Colorado | 80218-1088 | United States | ||
| Duramed Investigational Site |
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Seasonique | Seasonique , 1 tablet daily |
| FG001 | Placebo | Placebo, 1 tablet daily |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Placebo tablet | Drug | 1 tablet daily by mouth |
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| 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 | number of days analgesic (pain) medication was used over the 13 week treatment period | 13-week treatment period |
| Decatur |
| Georgia |
| 30034 |
| United States |
| Duramed Investigational Site | Louisville | Kentucky | 40202 | United States |
| Duramed Investigational Site | St Louis | Missouri | 63110 | United States |
| Duramed Investigational Site | Cincinnati | Ohio | 45229 | United States |
| Duramed Investigational Site | Cleveland | Ohio | 44109 | United States |
| Duramed Investigational Site | Columbus | Ohio | 43205 | United States |
| Duramed Investigational Site | Medford | Oregon | 97504 | United States |
| Duramed Investigational Site | Philadelphia | Pennsylvania | 19114 | United States |
| Duramed Investigational Site | Pittsburgh | Pennsylvania | 15213 | United States |
| Duramed Investigational Site | Willow Grove | Pennsylvania | 19090 | United States |
| Duramed Investigational Site | Providence | Rhode Island | 02903 | United States |
| Duramed Investigational Site | Salt Lake City | Utah | 84124 | United States |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Seasonique | Seasonique , 1 tablet daily |
| BG001 | Placebo | Placebo, 1 tablet daily |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | participants |
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| Body Mass Index | Mean | Standard Deviation | kg/m^2 |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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") | 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. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline to end of 13-week treatment period |
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| 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") | 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. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline to end of Week 13 |
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| Secondary | Incidence of Menstrual Bleeding and /or Spotting | 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. | Posted | Mean | Standard Deviation | Days of bleeding/spotting over 13 weeks | Baseline to end of Week 13 |
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| Secondary | Number of Days Missed From School/Work or Other Activities | 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. | Posted | Mean | Standard Deviation | Days | 13-week treatment period |
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| Secondary | Analgesic Use | number of days analgesic (pain) medication was used over the 13 week treatment period | 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. | Posted | Mean | Standard Deviation | Days Analgesic was used over 13 weeks | 13-week treatment period |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Seasonique | Seasonique , 1 tablet daily | 2 | 47 | 47 | 47 | ||
| EG001 | Placebo | Placebo, 1 tablet daily | 0 | 48 | 17 | 48 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Excruciating pain rlated to menstruation | Reproductive system and breast disorders | Systematic Assessment |
| ||
| Exacerbation of Stress | Psychiatric disorders |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Sinusitis | Infections and infestations |
| |||
| Nasopharyngitis | Infections and infestations |
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| Gastroenteritis Viral | Infections and infestations |
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| Pharyngitis Streptococcal | Infections and infestations |
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| Nausea | Gastrointestinal disorders |
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| Abdominal Pain Upper | Gastrointestinal disorders |
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| Diarrhoea | Gastrointestinal disorders |
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| Vomiting | Gastrointestinal disorders |
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| Headache | Nervous system disorders |
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| Pharyngolaryngeal Pain | Respiratory, thoracic and mediastinal disorders |
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The sponsor can (i) review results communications prior to public release and can embargo communications regarding trial results for a period of at least 60 days but no more than 180 days from the time submitted to the sponsor for review; and (ii) require in instances of a multi-center study, that a single PI not disclose study data until after the multi-center results are published, provided such results are published within eighteen (18) months of the conclusion of the study.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Duramed Research Protocol Chair | Duramed Research | 215-293-7279 | role_medical_affairs@tevapharm.com |
| ID | Term |
|---|---|
| D004412 | Dysmenorrhea |
| ID | Term |
|---|---|
| D008599 | Menstruation Disturbances |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D017699 | Pelvic Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| C000606708 | Seasonique |
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| Male |
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| Caucasian |
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| Hispanic |
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| Other |
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