Trial Outcomes & Findings for A Study to Evaluate the Efficacy of Seasonique for the Treatment of Cyclic Pelvic Pain (NCT NCT00196313)
NCT ID: NCT00196313
Last Updated: 2016-09-22
Results Overview
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")
COMPLETED
PHASE2
95 participants
Baseline to end of 13-week treatment period
2016-09-22
Participant Flow
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.
Participant milestones
| Measure |
Seasonique
Seasonique
, 1 tablet daily
|
Placebo
Placebo, 1 tablet daily
|
|---|---|---|
|
Overall Study
STARTED
|
47
|
48
|
|
Overall Study
COMPLETED
|
36
|
40
|
|
Overall Study
NOT COMPLETED
|
11
|
8
|
Reasons for withdrawal
| Measure |
Seasonique
Seasonique
, 1 tablet daily
|
Placebo
Placebo, 1 tablet daily
|
|---|---|---|
|
Overall Study
Protocol Violation
|
2
|
3
|
|
Overall Study
Withdrawal by Subject
|
3
|
1
|
|
Overall Study
Adverse Event
|
3
|
1
|
|
Overall Study
Subject Pregnant
|
1
|
1
|
|
Overall Study
Lost to Follow-up
|
2
|
2
|
Baseline Characteristics
A Study to Evaluate the Efficacy of Seasonique for the Treatment of Cyclic Pelvic Pain
Baseline characteristics by cohort
| Measure |
Seasonique
n=47 Participants
Seasonique
, 1 tablet daily
|
Placebo
n=48 Participants
Placebo, 1 tablet daily
|
Total
n=95 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
15.5 Years
STANDARD_DEVIATION 1.23 • n=5 Participants
|
15.4 Years
STANDARD_DEVIATION 1.36 • n=7 Participants
|
15.5 Years
STANDARD_DEVIATION 1.29 • n=5 Participants
|
|
Sex: Female, Male
Female
|
47 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
95 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African-American
|
18 participants
n=5 Participants
|
17 participants
n=7 Participants
|
35 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
29 participants
n=5 Participants
|
27 participants
n=7 Participants
|
56 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
0 participants
n=5 Participants
|
3 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Body Mass Index
|
24.8 kg/m^2
STANDARD_DEVIATION 6.88 • n=5 Participants
|
26.4 kg/m^2
STANDARD_DEVIATION 7.16 • n=7 Participants
|
25.6 kg/m^2
STANDARD_DEVIATION 7.04 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to end of 13-week treatment periodPopulation: 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.
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")
Outcome measures
| Measure |
Seasonique
n=36 Participants
Seasonique
, 1 tablet daily
|
Placebo
n=40 Participants
Placebo, 1 tablet daily
|
|---|---|---|
|
Mean Change in Average Severity for Abdominal/Pelvic Pain
|
-0.45 units on a scale
Standard Error 0.060
|
-0.19 units on a scale
Standard Error 0.058
|
SECONDARY outcome
Timeframe: Baseline to end of Week 13Population: 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.
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")
Outcome measures
| Measure |
Seasonique
n=36 Participants
Seasonique
, 1 tablet daily
|
Placebo
n=40 Participants
Placebo, 1 tablet daily
|
|---|---|---|
|
Change From Baseline in Maximum Severity of Abdominal/Pelvic Pain
|
-0.62 units on a scale
Standard Error 0.120
|
-0.17 units on a scale
Standard Error 0.117
|
SECONDARY outcome
Timeframe: Baseline to end of Week 13Population: 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.
Outcome measures
| Measure |
Seasonique
n=36 Participants
Seasonique
, 1 tablet daily
|
Placebo
n=40 Participants
Placebo, 1 tablet daily
|
|---|---|---|
|
Incidence of Menstrual Bleeding and /or Spotting
|
28.389 Days of bleeding/spotting over 13 weeks
Standard Deviation 14.705
|
18.000 Days of bleeding/spotting over 13 weeks
Standard Deviation 6.026
|
SECONDARY outcome
Timeframe: 13-week treatment periodPopulation: 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.
Outcome measures
| Measure |
Seasonique
n=36 Participants
Seasonique
, 1 tablet daily
|
Placebo
n=40 Participants
Placebo, 1 tablet daily
|
|---|---|---|
|
Number of Days Missed From School/Work or Other Activities
|
0.83 Days
Standard Deviation 1.844
|
2.75 Days
Standard Deviation 3.418
|
SECONDARY outcome
Timeframe: 13-week treatment periodPopulation: 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.
number of days analgesic (pain) medication was used over the 13 week treatment period
Outcome measures
| Measure |
Seasonique
n=36 Participants
Seasonique
, 1 tablet daily
|
Placebo
n=40 Participants
Placebo, 1 tablet daily
|
|---|---|---|
|
Analgesic Use
|
2.92 Days Analgesic was used over 13 weeks
Standard Deviation 3.281
|
4.03 Days Analgesic was used over 13 weeks
Standard Deviation 5.356
|
Adverse Events
Seasonique
Placebo
Serious adverse events
| Measure |
Seasonique
n=47 participants at risk
Seasonique
, 1 tablet daily
|
Placebo
n=48 participants at risk
Placebo, 1 tablet daily
|
|---|---|---|
|
Reproductive system and breast disorders
Excruciating pain rlated to menstruation
|
2.1%
1/47 • Number of events 1
|
0.00%
0/48
|
|
Psychiatric disorders
Exacerbation of Stress
|
2.1%
1/47 • Number of events 1
|
0.00%
0/48
|
Other adverse events
| Measure |
Seasonique
n=47 participants at risk
Seasonique
, 1 tablet daily
|
Placebo
n=48 participants at risk
Placebo, 1 tablet daily
|
|---|---|---|
|
Infections and infestations
Sinusitis
|
12.8%
6/47 • Number of events 6
|
0.00%
0/48
|
|
Infections and infestations
Nasopharyngitis
|
10.6%
5/47 • Number of events 5
|
10.4%
5/48 • Number of events 5
|
|
Infections and infestations
Gastroenteritis Viral
|
8.5%
4/47 • Number of events 4
|
0.00%
0/48
|
|
Infections and infestations
Pharyngitis Streptococcal
|
6.4%
3/47 • Number of events 3
|
0.00%
0/48
|
|
Gastrointestinal disorders
Nausea
|
19.1%
9/47 • Number of events 9
|
6.2%
3/48 • Number of events 3
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
8.5%
4/47 • Number of events 4
|
6.2%
3/48 • Number of events 3
|
|
Gastrointestinal disorders
Diarrhoea
|
8.5%
4/47 • Number of events 4
|
2.1%
1/48 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
6.4%
3/47 • Number of events 3
|
4.2%
2/48 • Number of events 2
|
|
Nervous system disorders
Headache
|
19.1%
9/47 • Number of events 9
|
6.2%
3/48 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal Pain
|
6.4%
3/47 • Number of events 3
|
0.00%
0/48
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER