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A Study to Evaluate the Efficacy of Seasonique for the Treatment of Cyclic Pelvic Pain

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ClinicalTrials.gov Identifier: NCT00196313
Recruitment Status : Completed
First Posted : September 20, 2005
Results First Posted : May 25, 2012
Last Update Posted : September 22, 2016
Sponsor:
Information provided by (Responsible Party):
Teva Pharmaceutical Industries ( Duramed Research )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Dysmenorrhea
Interventions Drug: levonorgestrel/EE 0.15/0.03 and EE 0.01 mg tablets
Drug: Placebo tablet
Enrollment 95
Recruitment Details  
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.
Arm/Group Title Seasonique Placebo
Hide Arm/Group Description

Seasonique

, 1 tablet daily

Placebo, 1 tablet daily
Period Title: Overall Study
Started 47 48
Completed 36 40
Not Completed 11 8
Reason Not Completed
Protocol Violation             2             3
Withdrawal by Subject             3             1
Adverse Event             3             1
Subject Pregnant             1             1
Lost to Follow-up             2             2
Arm/Group Title Seasonique Placebo Total
Hide Arm/Group Description

Seasonique

, 1 tablet daily

Placebo, 1 tablet daily Total of all reporting groups
Overall Number of Baseline Participants 47 48 95
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 47 participants 48 participants 95 participants
15.5  (1.23) 15.4  (1.36) 15.5  (1.29)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 47 participants 48 participants 95 participants
Female
47
 100.0%
48
 100.0%
95
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 47 participants 48 participants 95 participants
African-American 18 17 35
Caucasian 29 27 56
Hispanic 0 3 3
Other 0 1 1
Body Mass Index  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 47 participants 48 participants 95 participants
24.8  (6.88) 26.4  (7.16) 25.6  (7.04)
1.Primary Outcome
Title Mean Change in Average Severity for Abdominal/Pelvic Pain
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Seasonique Placebo
Hide Arm/Group Description:

Seasonique

, 1 tablet daily

Placebo, 1 tablet daily
Overall Number of Participants Analyzed 36 40
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-0.45  (0.060) -0.19  (0.058)
2.Secondary Outcome
Title Change From Baseline in Maximum Severity of Abdominal/Pelvic Pain
Hide Description

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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Seasonique Placebo
Hide Arm/Group Description:

Seasonique

, 1 tablet daily

Placebo, 1 tablet daily
Overall Number of Participants Analyzed 36 40
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-0.62  (0.120) -0.17  (0.117)
3.Secondary Outcome
Title Incidence of Menstrual Bleeding and /or Spotting
Hide Description [Not Specified]
Time Frame Baseline to end of Week 13
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Seasonique Placebo
Hide Arm/Group Description:
Seasonique, 1 tablet daily
Placebo, 1 tablet daily
Overall Number of Participants Analyzed 36 40
Mean (Standard Deviation)
Unit of Measure: Days of bleeding/spotting over 13 weeks
28.389  (14.705) 18.000  (6.026)
4.Secondary Outcome
Title Number of Days Missed From School/Work or Other Activities
Hide Description [Not Specified]
Time Frame 13-week treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Seasonique Placebo
Hide Arm/Group Description:

Seasonique

, 1 tablet daily

Placebo, 1 tablet daily
Overall Number of Participants Analyzed 36 40
Mean (Standard Deviation)
Unit of Measure: Days
0.83  (1.844) 2.75  (3.418)
5.Secondary Outcome
Title Analgesic Use
Hide Description number of days analgesic (pain) medication was used over the 13 week treatment period
Time Frame 13-week treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Seasonique Placebo
Hide Arm/Group Description:
Seasonique, 1 tablet daily
Placebo, 1 tablet daily
Overall Number of Participants Analyzed 36 40
Mean (Standard Deviation)
Unit of Measure: Days Analgesic was used over 13 weeks
2.92  (3.281) 4.03  (5.356)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Seasonique Placebo
Hide Arm/Group Description

Seasonique

, 1 tablet daily

Placebo, 1 tablet daily
All-Cause Mortality
Seasonique Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Seasonique Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/47 (4.26%)      0/48 (0.00%)    
Psychiatric disorders     
Exacerbation of Stress  1/47 (2.13%)  1 0/48 (0.00%)  0
Reproductive system and breast disorders     
Excruciating pain rlated to menstruation   1/47 (2.13%)  1 0/48 (0.00%)  0
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Seasonique Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   47/47 (100.00%)      17/48 (35.42%)    
Gastrointestinal disorders     
Nausea  9/47 (19.15%)  9 3/48 (6.25%)  3
Abdominal Pain Upper  4/47 (8.51%)  4 3/48 (6.25%)  3
Diarrhoea  4/47 (8.51%)  4 1/48 (2.08%)  1
Vomiting  3/47 (6.38%)  3 2/48 (4.17%)  2
Infections and infestations     
Sinusitis  6/47 (12.77%)  6 0/48 (0.00%)  0
Nasopharyngitis  5/47 (10.64%)  5 5/48 (10.42%)  5
Gastroenteritis Viral  4/47 (8.51%)  4 0/48 (0.00%)  0
Pharyngitis Streptococcal  3/47 (6.38%)  3 0/48 (0.00%)  0
Nervous system disorders     
Headache  9/47 (19.15%)  9 3/48 (6.25%)  3
Respiratory, thoracic and mediastinal disorders     
Pharyngolaryngeal Pain  3/47 (6.38%)  3 0/48 (0.00%)  0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Duramed Research Protocol Chair
Organization: Duramed Research
Phone: 215-293-7279
EMail: role_medical_affairs@tevapharm.com
Layout table for additonal information
Responsible Party: Teva Pharmaceutical Industries ( Duramed Research )
ClinicalTrials.gov Identifier: NCT00196313    
Other Study ID Numbers: DR-PSE-306
First Submitted: September 12, 2005
First Posted: September 20, 2005
Results First Submitted: October 12, 2011
Results First Posted: May 25, 2012
Last Update Posted: September 22, 2016