This is a multi-center study to evaluate hormone levels with the oral contraceptive regimen DR-1021.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
61
Twenty-one 150 μg desogestrel/20 μg ethinyl estradiol (EE) combination tablets plus seven 10 μg EE tablets.
Twenty-one 150 μg desogestrel/20 μg ethinyl estradiol (EE) combination tablets plus two placebo tablets plus five 10 μg EE tablets.
Twenty-one 150 μg desogestrel/20 μg ethinyl estradiol (EE) combination tablets plus two placebo tablets plus five 10 μg EE tablets.
Duramed Investigational Site
Lawrenceville, New Jersey, United States
Duramed Investigational Site
Columbus, Ohio, United States
Duramed Investigational Site
Philadelphia, Pennsylvania, United States
Duramed Investigational Site
Seattle, Washington, United States
Serum Estradiol Levels by Cycle Day
Levels of estradiol were measured throughout the study from blood samples.
Time frame: Cycle 2, Day 2 (Baseline), and Days 4, 6, 19-20, 23, 24, 25, 27, 28, Cycle 3, Days 2, 4 and 6.
Serum Follicle Stimulating Hormone (FSH) Levels by Cycle Day
Levels of follicle stimulating hormone were measured throughout the study from blood samples.
Time frame: Cycle 2, Day 2 (Baseline), and Days 4, 6, 19-20, 23, 24, 25, 27, 28, Cycle 3, Days 2, 4 and 6.
Serum Inhibin-B Levels by Cycle Day
Levels of inhibin-B were measured throughout the study from blood samples.
Time frame: Cycle 2, Day 2 (Baseline), and Days 4, 6, 19-20, 23, 24, 25, 27, 28, Cycle 3, Days 2, 4 and 6.
Percentage of Follicles Greater Than 5 mm in Diameter
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).
Time frame: Cycle 1, Days 11, 19-20, 23, 25, 27, Cycle 2, Days 4, 11, 19-20, 23, 25, 27, Cycle 3, Day 4.
Change From Cycle 2 Days 1 - 20 to Cycle 2 Days 21 - 28 in Maximum Follicle Size
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.
Time frame: Cycle 2, Days 1-20 and Cycle 2, Days 21-28
Number of Days of Bleeding or Spotting During Unscheduled and Scheduled Study Periods
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.
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Time frame: Cycle 2, Days 1-21, Cycle 2, Days 22-28 and Cycle 3, Days 1-21
Percentage of Participants With Bleeding or Spotting During Unscheduled and Scheduled Study Periods
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.
Time frame: Cycle 2, Days 1-21, Cycle 2, Days 22-28 and Cycle 3, Days 1-21
Number of Days of Bleeding During Unscheduled and Scheduled Study Periods
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.
Time frame: Cycle 2, Days 1-21, Cycle 2, Days 22-28 and Cycle 3, Days 1-21
Percentage of Participants With Bleeding During Unscheduled and Scheduled Study Periods
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.
Time frame: Cycle 2, Days 1-21, Cycle 2, Days 22-28 and Cycle 3, Days 1-21