A Study to Evaluate Hormone Patterns and Ovarian Follicular Activity With DR-1021

Sponsor
Teva Branded Pharmaceutical Products R&D, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT00544882
Collaborator
(none)
61
Enrollment
4
Locations
2
Arms
5
Actual Duration (Months)
15.3
Patients Per Site
3.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a multi-center study to evaluate hormone levels with the oral contraceptive regimen DR-1021.

Condition or DiseaseIntervention/TreatmentPhase
Phase 3

Detailed Description

Female volunteers, aged 18-35 years old who met all Inclusion and no Exclusion Criteria, were enrolled in this study. All participants were current users of a standard 21/7 oral contraceptive regimen (21 days of combination progestin/estrogen followed by 7 days placebo) and had completed at least one 28-day cycle prior to beginning the Cycle 1 baseline cycle. After completing screening, all enrolled participants continued to receive the same regimen of 150 μg DSG /20 μg EE combination pills once daily for 21 days followed by placebo once daily for 7 days during Cycle 1 (the Run-In phase). Following completion of Cycle 1, participants were randomly assigned to receive either DR-1021 or Mircette during Cycle 2. All participants who completed Cycle 2 were to receive Kariva during Cycle 3; however, participants were only followed for the first 21 days of this 28-day regimen, after which they were considered study completers.

Study Design

Study Type:
Interventional
Actual Enrollment :
61 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
A Prospective, Multicenter, Randomized, Double-Blind Study to Evaluate Hormone Patterns and Ovarian Follicular Activity With the Oral Contraceptive Regimen DR-1021
Actual Study Start Date :
Oct 31, 2007
Actual Primary Completion Date :
Mar 31, 2008
Actual Study Completion Date :
Mar 31, 2008

Arms and Interventions

ArmIntervention/Treatment
Experimental: DR-1021

After randomization, participants received DR-1021 consisting of 150 μg desogestrel (DSG)/20 μg ethinyl estradiol (EE) administered orally as a combination tablet once daily for 21 days followed by EE 10 μg tablet once daily for 7 days (Cycle 2). Participants who completed Cycle 2 then received Kariva, consisting of 150 μg DSG/20 μg EE administered orally as a combination tablet taken once daily for 21 days followed by placebo tablet once daily for 2 days followed by 10 μg EE taken once daily for 5 days (Cycle 3).

Drug: DR-1021
Twenty-one 150 μg desogestrel/20 μg ethinyl estradiol (EE) combination tablets plus seven 10 μg EE tablets.
Other Names:
  • desogestrel/ethinyl estradiol
  • Drug: Kariva®
    Twenty-one 150 μg desogestrel/20 μg ethinyl estradiol (EE) combination tablets plus two placebo tablets plus five 10 μg EE tablets.
    Other Names:
  • desogestrel/ethinyl estradiol
  • Active Comparator: Mircette

    After randomization, participants received Mircette consisting of 150 μg desogestrel (DSG)/20 μg ethinyl estradiol (EE) administered orally as a combination tablet once daily for 21 days followed by placebo tablet once daily for 2 days followed by 10 μg EE tablet once daily for 5 days (Cycle 2). Participants who completed Cycle 2 then received Kariva, consisting of 150 μg DSG/20 μg EE administered orally as a combination tablet taken once daily for 21 days followed by placebo tablet once daily for 2 days followed by 10 μg EE taken once daily for 5 days (Cycle 3).

    Drug: Mircette®
    Twenty-one 150 μg desogestrel/20 μg ethinyl estradiol (EE) combination tablets plus two placebo tablets plus five 10 μg EE tablets.
    Other Names:
  • desogestrel/ethinyl estradiol
  • Drug: Kariva®
    Twenty-one 150 μg desogestrel/20 μg ethinyl estradiol (EE) combination tablets plus two placebo tablets plus five 10 μg EE tablets.
    Other Names:
  • desogestrel/ethinyl estradiol
  • Outcome Measures

    Primary Outcome Measures

    1. Serum Estradiol Levels by Cycle Day [Cycle 2, Day 2 (Baseline), and Days 4, 6, 19-20, 23, 24, 25, 27, 28, Cycle 3, Days 2, 4 and 6.]

      Levels of estradiol were measured throughout the study from blood samples.

    2. Serum Follicle Stimulating Hormone (FSH) Levels by Cycle Day [Cycle 2, Day 2 (Baseline), and Days 4, 6, 19-20, 23, 24, 25, 27, 28, Cycle 3, Days 2, 4 and 6.]

      Levels of follicle stimulating hormone were measured throughout the study from blood samples.

    3. Serum Inhibin-B Levels by Cycle Day [Cycle 2, Day 2 (Baseline), and Days 4, 6, 19-20, 23, 24, 25, 27, 28, Cycle 3, Days 2, 4 and 6.]

      Levels of inhibin-B were measured throughout the study from blood samples.

    Secondary Outcome Measures

    1. Percentage of Follicles Greater Than 5 mm in Diameter [Cycle 1, Days 11, 19-20, 23, 25, 27, Cycle 2, Days 4, 11, 19-20, 23, 25, 27, Cycle 3, Day 4.]

      Ovarian follicles were measured by trans-vaginal ultrasound. The size of the 3 largest follicles was documented for each participant, and the percentage of follicles greater than 5 mm in diameter was calculated based on the total number follicles present (indicated by n for each time point).

    2. Change From Cycle 2 Days 1 - 20 to Cycle 2 Days 21 - 28 in Maximum Follicle Size [Cycle 2, Days 1-20 and Cycle 2, Days 21-28]

      The change in the size of the largest documented follicle during combination therapy (Days 1 to 21) and during monotherapy/placebo (Days 21-28) measured by trans-vaginal ultrasound.

    3. Number of Days of Bleeding or Spotting During Unscheduled and Scheduled Study Periods [Cycle 2, Days 1-21, Cycle 2, Days 22-28 and Cycle 3, Days 1-21]

      The total number of days of unscheduled (Day 1 to Day 21 of each cycle) and scheduled (ie,withdrawal [Day 22 to Day 28 of each cycle]) bleeding or spotting was derived from participant diaries.

    4. Percentage of Participants With Bleeding or Spotting During Unscheduled and Scheduled Study Periods [Cycle 2, Days 1-21, Cycle 2, Days 22-28 and Cycle 3, Days 1-21]

      The percentage of participants with unscheduled (Day 1 to Day 21 of each cycle) and scheduled (ie,withdrawal [Day 22 to Day 28 of each cycle]) bleeding or spotting was derived from participant diaries.

    5. Number of Days of Bleeding During Unscheduled and Scheduled Study Periods [Cycle 2, Days 1-21, Cycle 2, Days 22-28 and Cycle 3, Days 1-21]

      The total number of days of unscheduled (Day 1 to Day 21 of each cycle) and scheduled (ie,withdrawal [Day 22 to Day 28 of each cycle]) bleeding (not including spotting) was derived from participant diaries.

    6. Percentage of Participants With Bleeding During Unscheduled and Scheduled Study Periods [Cycle 2, Days 1-21, Cycle 2, Days 22-28 and Cycle 3, Days 1-21]

      The percentage of participants with unscheduled (Day 1 to Day 21 of each cycle) and scheduled (ie,withdrawal [Day 22 to Day 28 of each cycle]) bleeding (not including spotting) was derived from participant diaries.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 35 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • Premenopausal

    • Weight <200 lbs

    • Currently taking or willing to be treated with an oral contraceptive with a standard 21/7 regimen for one cycle prior to starting Study Cycle 1

    • Others as dictated by protocol

    Exclusion Criteria:
    • Any contraindication to the use of oral contraceptives

    • Breast feeding

    • Smoking > 10 cigarettes per day

    • Use of drugs that require simultaneous use of contraceptives (e.g., isotretinoin [Accutane])

    • Others as dictated by protocol

    Contacts and Locations

    Locations

    SiteCityStateCountryPostal Code
    1Duramed Investigational SiteLawrencevilleNew JerseyUnited States08648
    2Duramed Investigational SiteColumbusOhioUnited States43213
    3Duramed Investigational SitePhiladelphiaPennsylvaniaUnited States19114
    4Duramed Investigational SiteSeattleWashingtonUnited States98105

    Sponsors and Collaborators

    • Teva Branded Pharmaceutical Products R&D, Inc.

    Investigators

    • Study Chair: Duramed Protocol Chair, Duramed Research, Inc.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Teva Branded Pharmaceutical Products R&D, Inc.
    ClinicalTrials.gov Identifier:
    NCT00544882
    Other Study ID Numbers:
    • DR-DSG-302
    First Posted:
    Oct 16, 2007
    Last Update Posted:
    Nov 18, 2021
    Last Verified:
    Nov 1, 2021

    Study Results

    Participant Flow

    Recruitment DetailsFemale volunteers, aged 18-35 years old who were current users of a standard 21/7 oral contraceptive regimen (21 days of combination progestin/estrogen followed by 7 days placebo) were enrolled at 4 investigative sites in the United States.
    Pre-assignment Detail67 women were screened for participation in this study; 61 were enrolled and took at least 1 dose of their current regimen of oral contraceptive in Cycle 1 (the Run-in Cycle). Of the 61 enrolled, 3 participants discontinued the study prior to completing the Run-in Cycle and were therefore not randomly assigned to study drug in Cycle 2.
    Arm/Group TitleRun-In Cycle - All EnrolledDR-1021Mircette
    Arm/Group DescriptionAfter completing screening, all enrolled participants received the same regimen of 150 μg Desogestrel (DSG) /20 μg Ethinyl Estradiol (EE) combination pills once daily for 21 days followed by placebo once daily for 7 days during Cycle 1.After randomization, participants received DR-1021 consisting of 150 μg desogestrel (DSG)/20 μg ethinyl estradiol (EE) administered orally as a combination tablet once daily for 21 days followed by EE 10 μg tablet once daily for 7 days (Cycle 2). Participants who completed Cycle 2 then received Kariva, consisting of 150 μg DSG/20 μg EE administered orally as a combination tablet taken once daily for 21 days followed by placebo tablet once daily for 2 days followed by 10 μg EE taken once daily for 5 days (Cycle 3).After randomization, participants received Mircette consisting of 150 μg desogestrel (DSG)/20 μg ethinyl estradiol (EE) administered orally as a combination tablet once daily for 21 days followed by placebo tablet once daily for 2 days followed by 10 μg EE tablet once daily for 5 days (Cycle 2). Participants who completed Cycle 2 then received Kariva, consisting of 150 μg DSG/20 μg EE administered orally as a combination tablet taken once daily for 21 days followed by placebo tablet once daily for 2 days followed by 10 μg EE taken once daily for 5 days (Cycle 3).
    Period Title: Cycle 1: Run-in Cycle
    STARTED6100
    COMPLETED5800
    NOT COMPLETED300
    Period Title: Cycle 1: Run-in Cycle
    STARTED02929
    Treated02828
    COMPLETED02828
    NOT COMPLETED011
    Period Title: Cycle 1: Run-in Cycle
    STARTED02828
    COMPLETED02628
    NOT COMPLETED020

    Baseline Characteristics

    Arm/Group TitleDR-1021MircetteTotal
    Arm/Group DescriptionAfter randomization, participants received DR-1021 consisting of 150 μg desogestrel (DSG)/20 μg ethinyl estradiol (EE) administered orally as a combination tablet once daily for 21 days followed by EE 10 μg tablet once daily for 7 days (Cycle 2). Participants who completed Cycle 2 then received Kariva, consisting of 150 μg DSG/20 μg EE administered orally as a combination tablet taken once daily for 21 days followed by placebo tablet once daily for 2 days followed by 10 μg EE taken once daily for 5 days (Cycle 3).After randomization, participants received Mircette consisting of 150 μg desogestrel (DSG)/20 μg ethinyl estradiol (EE) administered orally as a combination tablet once daily for 21 days followed by placebo tablet once daily for 2 days followed by 10 μg EE tablet once daily for 5 days (Cycle 2). Participants who completed Cycle 2 then received Kariva, consisting of 150 μg DSG/20 μg EE administered orally as a combination tablet taken once daily for 21 days followed by placebo tablet once daily for 2 days followed by 10 μg EE taken once daily for 5 days (Cycle 3).Total of all reporting groups
    Overall Participants282856
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    27.3
    (4.68)
    28.0
    (4.38)
    27.7
    (4.51)
    Sex: Female, Male (Count of Participants)
    Female
    28
    100%
    28
    100%
    56
    100%
    Male
    0
    0%
    0
    0%
    0
    0%
    Race/Ethnicity, Customized (participants) [Number]
    African-American
    4
    14.3%
    6
    21.4%
    10
    17.9%
    Asian
    2
    7.1%
    0
    0%
    2
    3.6%
    Caucasian
    20
    71.4%
    20
    71.4%
    40
    71.4%
    Hispanic
    1
    3.6%
    1
    3.6%
    2
    3.6%
    Other
    1
    3.6%
    1
    3.6%
    2
    3.6%
    Region of Enrollment (participants) [Number]
    United States
    28
    100%
    28
    100%
    56
    100%

    Outcome Measures

    1. Primary Outcome
    TitleSerum Estradiol Levels by Cycle Day
    DescriptionLevels of estradiol were measured throughout the study from blood samples.
    Time FrameCycle 2, Day 2 (Baseline), and Days 4, 6, 19-20, 23, 24, 25, 27, 28, Cycle 3, Days 2, 4 and 6.

    Outcome Measure Data

    Analysis Population Description
    Intent-to-treat population with available data at each time point (as indicated by n).
    Arm/Group TitleDR-1021Mircette
    Arm/Group DescriptionAfter randomization, participants received DR-1021 consisting of 150 μg desogestrel (DSG)/20 μg ethinyl estradiol (EE) administered orally as a combination tablet once daily for 21 days followed by EE 10 μg tablet once daily for 7 days (Cycle 2). Participants who completed Cycle 2 then received Kariva, consisting of 150 μg DSG/20 μg EE administered orally as a combination tablet taken once daily for 21 days followed by placebo tablet once daily for 2 days followed by 10 μg EE taken once daily for 5 days (Cycle 3).After randomization, participants received Mircette consisting of 150 μg desogestrel (DSG)/20 μg ethinyl estradiol (EE) administered orally as a combination tablet once daily for 21 days followed by placebo tablet once daily for 2 days followed by 10 μg EE tablet once daily for 5 days (Cycle 2). Participants who completed Cycle 2 then received Kariva, consisting of 150 μg DSG/20 μg EE administered orally as a combination tablet taken once daily for 21 days followed by placebo tablet once daily for 2 days followed by 10 μg EE taken once daily for 5 days (Cycle 3).
    Measure Participants2828
    Cycle 2 - Day 2 (n=28, 28)
    47.00
    51.50
    Cycle 2 - Day 4 (n=28, 28)
    62.50
    34.50
    Cycle 2 - Day 6 (n=27, 27)
    43.00
    29.00
    Cycle 2 - Days 19-20 (n=26, 28)
    19.00
    20.50
    Cycle 2 - Day 23 (n=27, 28)
    24.00
    19.00
    Cycle 2 - Day 24 (n=25, 28)
    25.00
    26.50
    Cycle 2 - Day 25 (n=27, 28)
    24.00
    26.00
    Cycle 2 - Day 27 (n=25, 28)
    30.00
    20.00
    Cycle 2 - Day 28 (n=26, 28)
    36.00
    27.50
    Cycle 3 - Day 2 (n=27, 28)
    34.00
    43.00
    Cycle 3 - Day 4 (n=27, 27)
    66.00
    27.00
    Cycle 3 - Day 6 (n=24, 26)
    28.50
    32.00
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection DR-1021, Mircette
    Comments Comparison of treatment groups at Cycle 2 - Day 2 time point. p-values < 0.05 were considered statistically significant.
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesisp-Value0.6346
    Comments
    MethodWilcoxon (Mann-Whitney)
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection DR-1021, Mircette
    Comments Comparison of treatment groups at Cycle 2 - Day 4 time point.
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesisp-Value0.2757
    Comments
    MethodWilcoxon (Mann-Whitney)
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection DR-1021, Mircette
    Comments Comparison of treatment groups at Cycle 2 - Day 6 time point.
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesisp-Value0.1321
    Comments
    MethodWilcoxon (Mann-Whitney)
    Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection DR-1021, Mircette
    Comments Comparison of treatment groups at Cycle 2 - Days 19-20 time point.
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesisp-Value0.5543
    Comments
    MethodWilcoxon (Mann-Whitney)
    Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection DR-1021, Mircette
    Comments Comparison of treatment groups at Cycle 2 - Day 23 time point.
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesisp-Value0.3940
    Comments
    MethodWilcoxon (Mann-Whitney)
    Comments
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection DR-1021, Mircette
    Comments Comparison of treatment groups at Cycle 2 - Day 24 time point.
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesisp-Value0.7891
    Comments
    MethodWilcoxon (Mann-Whitney)
    Comments
    Statistical Analysis 7
    Statistical Analysis Overview Comparison Group Selection DR-1021, Mircette
    Comments Comparison of treatment groups at Cycle 2 - Day 25 time point.
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesisp-Value0.4829
    Comments
    MethodWilcoxon (Mann-Whitney)
    Comments
    Statistical Analysis 8
    Statistical Analysis Overview Comparison Group Selection DR-1021, Mircette
    Comments Comparison of treatment groups at Cycle 2 - Day 27 time point.
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesisp-Value0.4526
    Comments
    MethodWilcoxon (Mann-Whitney)
    Comments
    Statistical Analysis 9
    Statistical Analysis Overview Comparison Group Selection DR-1021, Mircette
    Comments Comparison of treatment groups at Cycle 2 - Day 28 time point.
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesisp-Value0.2485
    Comments
    MethodWilcoxon (Mann-Whitney)
    Comments
    Statistical Analysis 10
    Statistical Analysis Overview Comparison Group Selection DR-1021, Mircette
    Comments Comparison of treatment groups at Cycle 3 - Day 2 time point.
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesisp-Value0.6252
    Comments
    MethodWilcoxon (Mann-Whitney)
    Comments
    Statistical Analysis 11
    Statistical Analysis Overview Comparison Group Selection DR-1021, Mircette
    Comments Comparison of treatment groups at Cycle 3 - Day 4 time point.
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesisp-Value0.4003
    Comments
    MethodWilcoxon (Mann-Whitney)
    Comments
    Statistical Analysis 12
    Statistical Analysis Overview Comparison Group Selection DR-1021, Mircette
    Comments Comparison of treatment groups at Cycle 3 - Day 6 time point.
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesisp-Value0.8841
    Comments
    MethodWilcoxon (Mann-Whitney)
    Comments
    2. Secondary Outcome
    TitlePercentage of Follicles Greater Than 5 mm in Diameter
    DescriptionOvarian follicles were measured by trans-vaginal ultrasound. The size of the 3 largest follicles was documented for each participant, and the percentage of follicles greater than 5 mm in diameter was calculated based on the total number follicles present (indicated by n for each time point).
    Time FrameCycle 1, Days 11, 19-20, 23, 25, 27, Cycle 2, Days 4, 11, 19-20, 23, 25, 27, Cycle 3, Day 4.

    Outcome Measure Data

    Analysis Population Description
    Intent-to-treat
    Arm/Group TitleDR-1021Mircette
    Arm/Group DescriptionAfter randomization, participants received DR-1021 consisting of 150 μg desogestrel (DSG)/20 μg ethinyl estradiol (EE) administered orally as a combination tablet once daily for 21 days followed by EE 10 μg tablet once daily for 7 days (Cycle 2). Participants who completed Cycle 2 then received Kariva, consisting of 150 μg DSG/20 μg EE administered orally as a combination tablet taken once daily for 21 days followed by placebo tablet once daily for 2 days followed by 10 μg EE taken once daily for 5 days (Cycle 3).After randomization, participants received Mircette consisting of 150 μg desogestrel (DSG)/20 μg ethinyl estradiol (EE) administered orally as a combination tablet once daily for 21 days followed by placebo tablet once daily for 2 days followed by 10 μg EE tablet once daily for 5 days (Cycle 2). Participants who completed Cycle 2 then received Kariva, consisting of 150 μg DSG/20 μg EE administered orally as a combination tablet taken once daily for 21 days followed by placebo tablet once daily for 2 days followed by 10 μg EE taken once daily for 5 days (Cycle 3).
    Measure Participants2828
    Cycle 1 - Day 11 (n=63, 48)
    30.2
    29.2
    Cycle 1 - Day 19-20 (n= 47, 94)
    29.8
    27.7
    Cycle 1 - Day 23 (n= 30, 76)
    50.0
    26.3
    Cycle 1 - Day 25 (n= 85, 106)
    32.9
    31.1
    Cycle 1 - Day 27 (n=135, 145)
    29.6
    35.2
    Cycle 2 - Day 4 (n=154, 156)
    35.1
    31.4
    Cycle 2 - Day 11 (n=76, 54)
    27.6
    31.5
    Cycle 2 - Days 19-20 (n=143, 148)
    17.5
    18.9
    Cycle 2 - Day 23 (n=91, 62)
    24.2
    24.2
    Cycle 2 - Day 25 (n=69, 80)
    30.4
    18.8
    Cycle 2 - Day 27 (n=94, 132)
    23.4
    20.5
    Cycle 3 - Day 4 (n=138, 117)
    25.4
    27.4
    3. Primary Outcome
    TitleSerum Follicle Stimulating Hormone (FSH) Levels by Cycle Day
    DescriptionLevels of follicle stimulating hormone were measured throughout the study from blood samples.
    Time FrameCycle 2, Day 2 (Baseline), and Days 4, 6, 19-20, 23, 24, 25, 27, 28, Cycle 3, Days 2, 4 and 6.

    Outcome Measure Data

    Analysis Population Description
    Intent-to-treat population with available data at each time point (as indicated by n).
    Arm/Group TitleDR-1021Mircette
    Arm/Group DescriptionAfter randomization, participants received DR-1021 consisting of 150 μg desogestrel (DSG)/20 μg ethinyl estradiol (EE) administered orally as a combination tablet once daily for 21 days followed by EE 10 μg tablet once daily for 7 days (Cycle 2). Participants who completed Cycle 2 then received Kariva, consisting of 150 μg DSG/20 μg EE administered orally as a combination tablet taken once daily for 21 days followed by placebo tablet once daily for 2 days followed by 10 μg EE taken once daily for 5 days (Cycle 3).After randomization, participants received Mircette consisting of 150 μg desogestrel (DSG)/20 μg ethinyl estradiol (EE) administered orally as a combination tablet once daily for 21 days followed by placebo tablet once daily for 2 days followed by 10 μg EE tablet once daily for 5 days (Cycle 2). Participants who completed Cycle 2 then received Kariva, consisting of 150 μg DSG/20 μg EE administered orally as a combination tablet taken once daily for 21 days followed by placebo tablet once daily for 2 days followed by 10 μg EE taken once daily for 5 days (Cycle 3).
    Measure Participants2828
    Cycle 2 - Day 2 (n=28, 28)
    4.00
    4.00
    Cycle 2 - Day 4 (n=28, 28)
    3.55
    3.70
    Cycle 2 - Day 6 (n=28, 27)
    3.70
    3.50
    Cycle 2 - Days 19-20 (n=26, 28)
    1.45
    1.55
    Cycle 2 - Day 23 (n=27, 28)
    2.70
    2.35
    Cycle 2 - Day 24 (n=25, 28)
    2.80
    3.70
    Cycle 2 - Day 25 (n=27, 28)
    2.90
    3.90
    Cycle 2 - Day 27 (n=25, 28)
    3.70
    3.90
    Cycle 2 - Day 28 (n=26, 28)
    5.05
    4.70
    Cycle 3 - Day 2 (n=27, 28)
    4.90
    4.05
    Cycle 3 - Day 4 (n=27, 28)
    3.70
    3.60
    Cycle 3 - Day 6 (n=24, 26)
    2.50
    2.50
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection DR-1021, Mircette
    Comments Comparison of treatment groups at Cycle 2 - Day 2 time point. p-values < 0.05 were considered statistically significant.
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesisp-Value0.8892
    Comments
    MethodWilcoxon (Mann-Whitney)
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection DR-1021, Mircette
    Comments Comparison of treatment groups at Cycle 2 - Day 4 time point.
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesisp-Value0.7678
    Comments
    MethodWilcoxon (Mann-Whitney)
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection DR-1021, Mircette
    Comments Comparison of treatment groups at Cycle 2 - Day 6 time point.
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesisp-Value0.5782
    Comments
    MethodWilcoxon (Mann-Whitney)
    Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection DR-1021, Mircette
    Comments Comparison of treatment groups at Cycle 2 - Days 19-20 time point.
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesisp-Value0.8083
    Comments
    MethodWilcoxon (Mann-Whitney)
    Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection DR-1021, Mircette
    Comments Comparison of treatment groups at Cycle 2 - Day 23 time point.
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesisp-Value1.0000
    Comments
    MethodWilcoxon (Mann-Whitney)
    Comments
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection DR-1021, Mircette
    Comments Comparison of treatment groups at Cycle 2 - Day 24 time point.
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesisp-Value0.4122
    Comments
    MethodWilcoxon (Mann-Whitney)
    Comments
    Statistical Analysis 7
    Statistical Analysis Overview Comparison Group Selection DR-1021, Mircette
    Comments Comparison of treatment groups at Cycle 2 - Day 25 time point.
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesisp-Value0.6675
    Comments
    MethodWilcoxon (Mann-Whitney)
    Comments
    Statistical Analysis 8
    Statistical Analysis Overview Comparison Group Selection DR-1021, Mircette
    Comments Comparison of treatment groups at Cycle 2 - Day 27 time point.
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesisp-Value0.8445
    Comments
    MethodWilcoxon (Mann-Whitney)
    Comments
    Statistical Analysis 9
    Statistical Analysis Overview Comparison Group Selection DR-1021, Mircette
    Comments Comparison of treatment groups at Cycle 2 - Day 28 time point.
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesisp-Value0.3772
    Comments
    MethodWilcoxon (Mann-Whitney)
    Comments
    Statistical Analysis 10
    Statistical Analysis Overview Comparison Group Selection DR-1021, Mircette
    Comments Comparison of treatment groups at Cycle 3 - Day 2 time point.
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesisp-Value0.1918
    Comments
    MethodWilcoxon (Mann-Whitney)
    Comments
    Statistical Analysis 11
    Statistical Analysis Overview Comparison Group Selection DR-1021, Mircette
    Comments Comparison of treatment groups at Cycle 3 - Day 4 time point.
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesisp-Value0.6675
    Comments
    MethodWilcoxon (Mann-Whitney)
    Comments
    Statistical Analysis 12
    Statistical Analysis Overview Comparison Group Selection DR-1021, Mircette
    Comments Comparison of treatment groups at Cycle 3 - Day 6 time point.
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesisp-Value0.9226
    Comments
    MethodWilcoxon (Mann-Whitney)
    Comments
    4. Primary Outcome
    TitleSerum Inhibin-B Levels by Cycle Day
    DescriptionLevels of inhibin-B were measured throughout the study from blood samples.
    Time FrameCycle 2, Day 2 (Baseline), and Days 4, 6, 19-20, 23, 24, 25, 27, 28, Cycle 3, Days 2, 4 and 6.

    Outcome Measure Data

    Analysis Population Description
    Intent-to-treat population with available data at each time point (as indicated by n).
    Arm/Group TitleDR-1021Mircette
    Arm/Group DescriptionAfter randomization, participants received DR-1021 consisting of 150 μg desogestrel (DSG)/20 μg ethinyl estradiol (EE) administered orally as a combination tablet once daily for 21 days followed by EE 10 μg tablet once daily for 7 days (Cycle 2). Participants who completed Cycle 2 then received Kariva, consisting of 150 μg DSG/20 μg EE administered orally as a combination tablet taken once daily for 21 days followed by placebo tablet once daily for 2 days followed by 10 μg EE taken once daily for 5 days (Cycle 3).After randomization, participants received Mircette consisting of 150 μg desogestrel (DSG)/20 μg ethinyl estradiol (EE) administered orally as a combination tablet once daily for 21 days followed by placebo tablet once daily for 2 days followed by 10 μg EE tablet once daily for 5 days (Cycle 2). Participants who completed Cycle 2 then received Kariva, consisting of 150 μg DSG/20 μg EE administered orally as a combination tablet taken once daily for 21 days followed by placebo tablet once daily for 2 days followed by 10 μg EE taken once daily for 5 days (Cycle 3).
    Measure Participants2828
    Cycle 2 - Day 2 (n=28, 28)
    92.30
    99.00
    Cycle 2 - Day 4 (n=28, 28)
    42.80
    64.45
    Cycle 2 - Day 6 (n=28, 27)
    46.35
    41.20
    Cycle 2 - Days 19-20 (n=26, 28)
    23.15
    28.85
    Cycle 2 - Day 23 (n=27, 28)
    28.10
    32.15
    Cycle 2 - Day 24 (n=25, 28)
    36.80
    55.00
    Cycle 2 - Day 25 (n=27, 28)
    35.20
    62.30
    Cycle 2 - Day 27 (n=25, 28)
    39.60
    49.20
    Cycle 2 - Day 28 (n=26, 28)
    41.95
    55.05
    Cycle 3 - Day 2 (n=27, 28)
    54.70
    57.95
    Cycle 3 - Day 4 (n=27, 28)
    51.10
    52.25
    Cycle 3 - Day 6 (n=24, 26)
    36.15
    29.55
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection DR-1021, Mircette
    Comments Comparison of treatment groups at Cycle 2 - Day 2 time point. p-values < 0.05 were considered statistically significant.
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesisp-Value0.0979
    Comments
    MethodWilcoxon (Mann-Whitney)
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection DR-1021, Mircette
    Comments Comparison of treatment groups at Cycle 2 - Day 4 time point.
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesisp-Value0.0629
    Comments
    MethodWilcoxon (Mann-Whitney)
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection DR-1021, Mircette
    Comments Comparison of treatment groups at Cycle 2 - Day 6 time point.
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesisp-Value0.8464
    Comments
    MethodWilcoxon (Mann-Whitney)
    Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection DR-1021, Mircette
    Comments Comparison of treatment groups at Cycle 2 - Days 19-20 time point.
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesisp-Value0.6316
    Comments
    MethodWilcoxon (Mann-Whitney)
    Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection DR-1021, Mircette
    Comments Comparison of treatment groups at Cycle 2 - Day 23 time point.
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesisp-Value0.3000
    Comments
    MethodWilcoxon (Mann-Whitney)
    Comments
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection DR-1021, Mircette
    Comments Comparison of treatment groups at Cycle 2 - Day 24 time point.
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesisp-Value0.0955
    Comments
    MethodWilcoxon (Mann-Whitney)
    Comments
    Statistical Analysis 7
    Statistical Analysis Overview Comparison Group Selection DR-1021, Mircette
    Comments Comparison of treatment groups at Cycle 3 - Day 25 time point.
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesisp-Value0.1523
    Comments
    MethodWilcoxon (Mann-Whitney)
    Comments
    Statistical Analysis 8
    Statistical Analysis Overview Comparison Group Selection DR-1021, Mircette
    Comments Comparison of treatment groups at Cycle 2 - Day 27 time point.
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesisp-Value0.2809
    Comments
    MethodWilcoxon (Mann-Whitney)
    Comments
    Statistical Analysis 9
    Statistical Analysis Overview Comparison Group Selection DR-1021, Mircette
    Comments Comparison of treatment groups at Cycle 3 - Day 28 time point.
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesisp-Value0.8829
    Comments
    MethodWilcoxon (Mann-Whitney)
    Comments
    Statistical Analysis 10
    Statistical Analysis Overview Comparison Group Selection DR-1021, Mircette
    Comments Comparison of treatment groups at Cycle 3 - Day 2 time point.
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesisp-Value0.9262
    Comments
    MethodWilcoxon (Mann-Whitney)
    Comments
    Statistical Analysis 11
    Statistical Analysis Overview Comparison Group Selection DR-1021, Mircette
    Comments Comparison of treatment groups at Cycle 3 -Day 4 time point.
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesisp-Value0.7811
    Comments
    MethodWilcoxon (Mann-Whitney)
    Comments
    Statistical Analysis 12
    Statistical Analysis Overview Comparison Group Selection DR-1021, Mircette
    Comments Comparison of treatment groups at Cycle 3 - Day 6 time point.
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesisp-Value0.3703
    Comments
    MethodWilcoxon (Mann-Whitney)
    Comments
    5. Secondary Outcome
    TitleChange From Cycle 2 Days 1 - 20 to Cycle 2 Days 21 - 28 in Maximum Follicle Size
    DescriptionThe change in the size of the largest documented follicle during combination therapy (Days 1 to 21) and during monotherapy/placebo (Days 21-28) measured by trans-vaginal ultrasound.
    Time FrameCycle 2, Days 1-20 and Cycle 2, Days 21-28

    Outcome Measure Data

    Analysis Population Description
    Intent-to-treat population with available data.
    Arm/Group TitleDR-1021Mircette
    Arm/Group DescriptionAfter randomization, participants received DR-1021 consisting of 150 μg desogestrel (DSG)/20 μg ethinyl estradiol (EE) administered orally as a combination tablet once daily for 21 days followed by EE 10 μg tablet once daily for 7 days (Cycle 2). Participants who completed Cycle 2 then received Kariva, consisting of 150 μg DSG/20 μg EE administered orally as a combination tablet taken once daily for 21 days followed by placebo tablet once daily for 2 days followed by 10 μg EE taken once daily for 5 days (Cycle 3).After randomization, participants received Mircette consisting of 150 μg desogestrel (DSG)/20 μg ethinyl estradiol (EE) administered orally as a combination tablet once daily for 21 days followed by placebo tablet once daily for 2 days followed by 10 μg EE tablet once daily for 5 days (Cycle 2). Participants who completed Cycle 2 then received Kariva, consisting of 150 μg DSG/20 μg EE administered orally as a combination tablet taken once daily for 21 days followed by placebo tablet once daily for 2 days followed by 10 μg EE taken once daily for 5 days (Cycle 3).
    Measure Participants1818
    Mean (Standard Deviation) [mm]
    -2.02
    (6.076)
    -1.79
    (3.081)
    6. Secondary Outcome
    TitleNumber of Days of Bleeding or Spotting During Unscheduled and Scheduled Study Periods
    DescriptionThe total number of days of unscheduled (Day 1 to Day 21 of each cycle) and scheduled (ie,withdrawal [Day 22 to Day 28 of each cycle]) bleeding or spotting was derived from participant diaries.
    Time FrameCycle 2, Days 1-21, Cycle 2, Days 22-28 and Cycle 3, Days 1-21

    Outcome Measure Data

    Analysis Population Description
    Intent-to-treat
    Arm/Group TitleDR-1021Mircette
    Arm/Group DescriptionAfter randomization, participants received DR-1021 consisting of 150 μg desogestrel (DSG)/20 μg ethinyl estradiol (EE) administered orally as a combination tablet once daily for 21 days followed by EE 10 μg tablet once daily for 7 days (Cycle 2). Participants who completed Cycle 2 then received Kariva, consisting of 150 μg DSG/20 μg EE administered orally as a combination tablet taken once daily for 21 days followed by placebo tablet once daily for 2 days followed by 10 μg EE taken once daily for 5 days (Cycle 3).After randomization, participants received Mircette consisting of 150 μg desogestrel (DSG)/20 μg ethinyl estradiol (EE) administered orally as a combination tablet once daily for 21 days followed by placebo tablet once daily for 2 days followed by 10 μg EE tablet once daily for 5 days (Cycle 2). Participants who completed Cycle 2 then received Kariva, consisting of 150 μg DSG/20 μg EE administered orally as a combination tablet taken once daily for 21 days followed by placebo tablet once daily for 2 days followed by 10 μg EE taken once daily for 5 days (Cycle 3).
    Measure Participants2828
    Cycle 2 - Unscheduled (Day 1-21)
    2.19
    (3.732)
    1.41
    (1.551)
    Cycle 2 - Scheduled (Day 22-28)
    3.19
    (2.167)
    3.67
    (1.754)
    Cycle 3 - Unscheduled (Day 1-21)
    1.96
    (2.808)
    1.64
    (2.614)
    7. Secondary Outcome
    TitlePercentage of Participants With Bleeding or Spotting During Unscheduled and Scheduled Study Periods
    DescriptionThe percentage of participants with unscheduled (Day 1 to Day 21 of each cycle) and scheduled (ie,withdrawal [Day 22 to Day 28 of each cycle]) bleeding or spotting was derived from participant diaries.
    Time FrameCycle 2, Days 1-21, Cycle 2, Days 22-28 and Cycle 3, Days 1-21

    Outcome Measure Data

    Analysis Population Description
    Intent-to-treat
    Arm/Group TitleDR-1021Mircette
    Arm/Group DescriptionAfter randomization, participants received DR-1021 consisting of 150 μg desogestrel (DSG)/20 μg ethinyl estradiol (EE) administered orally as a combination tablet once daily for 21 days followed by EE 10 μg tablet once daily for 7 days (Cycle 2). Participants who completed Cycle 2 then received Kariva, consisting of 150 μg DSG/20 μg EE administered orally as a combination tablet taken once daily for 21 days followed by placebo tablet once daily for 2 days followed by 10 μg EE taken once daily for 5 days (Cycle 3).After randomization, participants received Mircette consisting of 150 μg desogestrel (DSG)/20 μg ethinyl estradiol (EE) administered orally as a combination tablet once daily for 21 days followed by placebo tablet once daily for 2 days followed by 10 μg EE tablet once daily for 5 days (Cycle 2). Participants who completed Cycle 2 then received Kariva, consisting of 150 μg DSG/20 μg EE administered orally as a combination tablet taken once daily for 21 days followed by placebo tablet once daily for 2 days followed by 10 μg EE taken once daily for 5 days (Cycle 3).
    Measure Participants2828
    Cycle 2 - Unscheduled (Day 1-21)
    48.1
    171.8%
    59.3
    211.8%
    Cycle 2 - Scheduled (Day 22-28)
    77.8
    277.9%
    92.6
    330.7%
    Cycle 3 - Unscheduled (Day 1-21)
    55.6
    198.6%
    53.6
    191.4%
    8. Secondary Outcome
    TitleNumber of Days of Bleeding During Unscheduled and Scheduled Study Periods
    DescriptionThe total number of days of unscheduled (Day 1 to Day 21 of each cycle) and scheduled (ie,withdrawal [Day 22 to Day 28 of each cycle]) bleeding (not including spotting) was derived from participant diaries.
    Time FrameCycle 2, Days 1-21, Cycle 2, Days 22-28 and Cycle 3, Days 1-21

    Outcome Measure Data

    Analysis Population Description
    Intent-to-treat
    Arm/Group TitleDR-1021Mircette
    Arm/Group DescriptionAfter randomization, participants received DR-1021 consisting of 150 μg desogestrel (DSG)/20 μg ethinyl estradiol (EE) administered orally as a combination tablet once daily for 21 days followed by EE 10 μg tablet once daily for 7 days (Cycle 2). Participants who completed Cycle 2 then received Kariva, consisting of 150 μg DSG/20 μg EE administered orally as a combination tablet taken once daily for 21 days followed by placebo tablet once daily for 2 days followed by 10 μg EE taken once daily for 5 days (Cycle 3).After randomization, participants received Mircette consisting of 150 μg desogestrel (DSG)/20 μg ethinyl estradiol (EE) administered orally as a combination tablet once daily for 21 days followed by placebo tablet once daily for 2 days followed by 10 μg EE tablet once daily for 5 days (Cycle 2). Participants who completed Cycle 2 then received Kariva, consisting of 150 μg DSG/20 μg EE administered orally as a combination tablet taken once daily for 21 days followed by placebo tablet once daily for 2 days followed by 10 μg EE taken once daily for 5 days (Cycle 3).
    Measure Participants2828
    Cycle 2 - Unscheduled (Day 1-21)
    0.70
    (2.127)
    0.52
    (0.935)
    Cycle 2 - Scheduled (Day 22-28)
    2.30
    (1.793)
    2.63
    (1.843)
    Cycle 3 - Unscheduled (Day 1-21)
    0.70
    (1.436)
    0.71
    (1.607)
    9. Secondary Outcome
    TitlePercentage of Participants With Bleeding During Unscheduled and Scheduled Study Periods
    DescriptionThe percentage of participants with unscheduled (Day 1 to Day 21 of each cycle) and scheduled (ie,withdrawal [Day 22 to Day 28 of each cycle]) bleeding (not including spotting) was derived from participant diaries.
    Time FrameCycle 2, Days 1-21, Cycle 2, Days 22-28 and Cycle 3, Days 1-21

    Outcome Measure Data

    Analysis Population Description
    Intent-to-treat
    Arm/Group TitleDR-1021Mircette
    Arm/Group DescriptionAfter randomization, participants received DR-1021 consisting of 150 μg desogestrel (DSG)/20 μg ethinyl estradiol (EE) administered orally as a combination tablet once daily for 21 days followed by EE 10 μg tablet once daily for 7 days (Cycle 2). Participants who completed Cycle 2 then received Kariva, consisting of 150 μg DSG/20 μg EE administered orally as a combination tablet taken once daily for 21 days followed by placebo tablet once daily for 2 days followed by 10 μg EE taken once daily for 5 days (Cycle 3).After randomization, participants received Mircette consisting of 150 μg desogestrel (DSG)/20 μg ethinyl estradiol (EE) administered orally as a combination tablet once daily for 21 days followed by placebo tablet once daily for 2 days followed by 10 μg EE tablet once daily for 5 days (Cycle 2). Participants who completed Cycle 2 then received Kariva, consisting of 150 μg DSG/20 μg EE administered orally as a combination tablet taken once daily for 21 days followed by placebo tablet once daily for 2 days followed by 10 μg EE taken once daily for 5 days (Cycle 3).
    Measure Participants2828
    Cycle 2 - Unscheduled (Day 1-21)
    18.5
    66.1%
    33.3
    118.9%
    Cycle 2 - Scheduled (Day 22-28)
    77.8
    277.9%
    77.8
    277.9%
    Cycle 3 - Unscheduled (Day 1-21)
    29.6
    105.7%
    25.0
    89.3%

    Adverse Events

    Time FrameFrom the date of the first randomized dose through 14 days after the last randomized dose, up to 42 days.
    Adverse Event Reporting Description
    Arm/Group TitleDR-1021Mircette
    Arm/Group DescriptionAfter randomization, participants received DR-1021 consisting of 150 μg desogestrel (DSG)/20 μg ethinyl estradiol (EE) administered orally as a combination tablet once daily for 21 days followed by EE 10 μg tablet once daily for 7 days (Cycle 2). Participants who completed Cycle 2 then received Kariva, consisting of 150 μg DSG/20 μg EE administered orally as a combination tablet taken once daily for 21 days followed by placebo tablet once daily for 2 days followed by 10 μg EE taken once daily for 5 days (Cycle 3).After randomization, participants received Mircette consisting of 150 μg desogestrel (DSG)/20 μg ethinyl estradiol (EE) administered orally as a combination tablet once daily for 21 days followed by placebo tablet once daily for 2 days followed by 10 μg EE tablet once daily for 5 days (Cycle 2). Participants who completed Cycle 2 then received Kariva, consisting of 150 μg DSG/20 μg EE administered orally as a combination tablet taken once daily for 21 days followed by placebo tablet once daily for 2 days followed by 10 μg EE taken once daily for 5 days (Cycle 3).
    All Cause Mortality
    DR-1021Mircette
    Affected / at Risk (%)# EventsAffected / at Risk (%)# Events
    Total/ (NaN) / (NaN)
    Serious Adverse Events
    DR-1021Mircette
    Affected / at Risk (%)# EventsAffected / at Risk (%)# Events
    Total0/28 (0%) 1/28 (3.6%)
    Respiratory, thoracic and mediastinal disorders
    Asthma0/28 (0%) 01/28 (3.6%) 1
    Other (Not Including Serious) Adverse Events
    DR-1021Mircette
    Affected / at Risk (%)# EventsAffected / at Risk (%)# Events
    Total7/28 (25%) 7/28 (25%)
    Infections and infestations
    Nasopharyngitis0/28 (0%) 02/28 (7.1%) 2
    Upper respiratory tract infection1/28 (3.6%) 14/28 (14.3%) 4
    Urinary tract infection2/28 (7.1%) 20/28 (0%) 0
    Musculoskeletal and connective tissue disorders
    Back pain2/28 (7.1%) 20/28 (0%) 0
    Nervous system disorders
    Headache0/28 (0%) 02/28 (7.1%) 2
    Respiratory, thoracic and mediastinal disorders
    Nasal congestion2/28 (7.1%) 21/28 (3.6%) 1

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    Sponsor has the right 60 days before submission for publication to review/provide comments. If the Sponsor's review shows that potentially patentable subject matter would be disclosed, publication or public disclosure shall be delayed for up to 90 additional days in order for the Sponsor, or Sponsor's designees, to file the necessary patent applications. In multicenter trials, each PI will postpone single center publications until after disclosure or publication of multicenter data.

    Results Point of Contact

    Name/TitleDirector of Clinical Research
    OrganizationTeva Branded Pharmaceutical Products R&D
    Phone610-786-7047
    Emailclinicaltrialsdisclosure@tevapharm.com
    Responsible Party:
    Teva Branded Pharmaceutical Products R&D, Inc.
    ClinicalTrials.gov Identifier:
    NCT00544882
    Other Study ID Numbers:
    • DR-DSG-302
    First Posted:
    Oct 16, 2007
    Last Update Posted:
    Nov 18, 2021
    Last Verified:
    Nov 1, 2021