Trial Outcomes & Findings for A Study to Evaluate Hormone Patterns and Ovarian Follicular Activity With DR-1021 (NCT NCT00544882)
NCT ID: NCT00544882
Last Updated: 2021-11-18
Results Overview
Levels of estradiol were measured throughout the study from blood samples.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
61 participants
Primary outcome timeframe
Cycle 2, Day 2 (Baseline), and Days 4, 6, 19-20, 23, 24, 25, 27, 28, Cycle 3, Days 2, 4 and 6.
Results posted on
2021-11-18
Participant Flow
Female 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.
67 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.
Participant milestones
| Measure |
Run-In Cycle - All Enrolled
After 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.
|
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).
|
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).
|
|---|---|---|---|
|
Cycle 1: Run-in Cycle
STARTED
|
61
|
0
|
0
|
|
Cycle 1: Run-in Cycle
COMPLETED
|
58
|
0
|
0
|
|
Cycle 1: Run-in Cycle
NOT COMPLETED
|
3
|
0
|
0
|
|
Cycle 2: Randomized Treatment Cycle
STARTED
|
0
|
29
|
29
|
|
Cycle 2: Randomized Treatment Cycle
Treated
|
0
|
28
|
28
|
|
Cycle 2: Randomized Treatment Cycle
COMPLETED
|
0
|
28
|
28
|
|
Cycle 2: Randomized Treatment Cycle
NOT COMPLETED
|
0
|
1
|
1
|
|
Cycle 3: Follow-up
STARTED
|
0
|
28
|
28
|
|
Cycle 3: Follow-up
COMPLETED
|
0
|
26
|
28
|
|
Cycle 3: Follow-up
NOT COMPLETED
|
0
|
2
|
0
|
Reasons for withdrawal
| Measure |
Run-In Cycle - All Enrolled
After 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.
|
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).
|
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).
|
|---|---|---|---|
|
Cycle 1: Run-in Cycle
Withdrawal by Subject
|
2
|
0
|
0
|
|
Cycle 1: Run-in Cycle
Adverse Event
|
1
|
0
|
0
|
|
Cycle 2: Randomized Treatment Cycle
Withdrawal by Subject
|
0
|
1
|
0
|
|
Cycle 2: Randomized Treatment Cycle
Noncompliance
|
0
|
0
|
1
|
|
Cycle 3: Follow-up
Noncompliance
|
0
|
1
|
0
|
|
Cycle 3: Follow-up
Pregnancy
|
0
|
1
|
0
|
Baseline Characteristics
A Study to Evaluate Hormone Patterns and Ovarian Follicular Activity With DR-1021
Baseline characteristics by cohort
| Measure |
DR-1021
n=28 Participants
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).
|
Mircette
n=28 Participants
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
n=56 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
27.3 years
STANDARD_DEVIATION 4.68 • n=5 Participants
|
28.0 years
STANDARD_DEVIATION 4.38 • n=7 Participants
|
27.7 years
STANDARD_DEVIATION 4.51 • n=5 Participants
|
|
Sex: Female, Male
Female
|
28 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
56 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
|
4 participants
n=5 Participants
|
6 participants
n=7 Participants
|
10 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
2 participants
n=5 Participants
|
0 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
20 participants
n=5 Participants
|
20 participants
n=7 Participants
|
40 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
28 participants
n=5 Participants
|
28 participants
n=7 Participants
|
56 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Cycle 2, Day 2 (Baseline), and Days 4, 6, 19-20, 23, 24, 25, 27, 28, Cycle 3, Days 2, 4 and 6.Population: Intent-to-treat population with available data at each time point (as indicated by n).
Levels of estradiol were measured throughout the study from blood samples.
Outcome measures
| Measure |
DR-1021
n=28 Participants
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).
|
Mircette
n=28 Participants
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).
|
|---|---|---|
|
Serum Estradiol Levels by Cycle Day
Cycle 2 - Day 2 (n=28, 28)
|
47.00 pg/mL
Interval 15.0 to 361.0
|
51.50 pg/mL
Interval 6.0 to 322.0
|
|
Serum Estradiol Levels by Cycle Day
Cycle 2 - Day 4 (n=28, 28)
|
62.50 pg/mL
Interval 1.0 to 613.0
|
34.50 pg/mL
Interval 1.0 to 423.0
|
|
Serum Estradiol Levels by Cycle Day
Cycle 2 - Day 6 (n=27, 27)
|
43.00 pg/mL
Interval 1.0 to 579.0
|
29.00 pg/mL
Interval 1.0 to 274.0
|
|
Serum Estradiol Levels by Cycle Day
Cycle 2 - Days 19-20 (n=26, 28)
|
19.00 pg/mL
Interval 1.0 to 152.0
|
20.50 pg/mL
Interval 1.0 to 327.0
|
|
Serum Estradiol Levels by Cycle Day
Cycle 2 - Day 23 (n=27, 28)
|
24.00 pg/mL
Interval 1.0 to 204.0
|
19.00 pg/mL
Interval 1.0 to 159.0
|
|
Serum Estradiol Levels by Cycle Day
Cycle 2 - Day 24 (n=25, 28)
|
25.00 pg/mL
Interval 1.0 to 289.0
|
26.50 pg/mL
Interval 1.0 to 169.0
|
|
Serum Estradiol Levels by Cycle Day
Cycle 2 - Day 25 (n=27, 28)
|
24.00 pg/mL
Interval 1.0 to 169.0
|
26.00 pg/mL
Interval 1.0 to 225.0
|
|
Serum Estradiol Levels by Cycle Day
Cycle 2 - Day 27 (n=25, 28)
|
30.00 pg/mL
Interval 1.0 to 233.0
|
20.00 pg/mL
Interval 1.0 to 213.0
|
|
Serum Estradiol Levels by Cycle Day
Cycle 2 - Day 28 (n=26, 28)
|
36.00 pg/mL
Interval 1.0 to 284.0
|
27.50 pg/mL
Interval 1.0 to 332.0
|
|
Serum Estradiol Levels by Cycle Day
Cycle 3 - Day 2 (n=27, 28)
|
34.00 pg/mL
Interval 1.0 to 425.0
|
43.00 pg/mL
Interval 3.0 to 217.0
|
|
Serum Estradiol Levels by Cycle Day
Cycle 3 - Day 4 (n=27, 27)
|
66.00 pg/mL
Interval 1.0 to 440.0
|
27.00 pg/mL
Interval 1.0 to 295.0
|
|
Serum Estradiol Levels by Cycle Day
Cycle 3 - Day 6 (n=24, 26)
|
28.50 pg/mL
Interval 1.0 to 277.0
|
32.00 pg/mL
Interval 3.0 to 197.0
|
PRIMARY outcome
Timeframe: Cycle 2, Day 2 (Baseline), and Days 4, 6, 19-20, 23, 24, 25, 27, 28, Cycle 3, Days 2, 4 and 6.Population: Intent-to-treat population with available data at each time point (as indicated by n).
Levels of follicle stimulating hormone were measured throughout the study from blood samples.
Outcome measures
| Measure |
DR-1021
n=28 Participants
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).
|
Mircette
n=28 Participants
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).
|
|---|---|---|
|
Serum Follicle Stimulating Hormone (FSH) Levels by Cycle Day
Cycle 2 - Day 2 (n=28, 28)
|
4.00 mIU/mL
Interval 2.3 to 9.7
|
4.00 mIU/mL
Interval 1.2 to 7.1
|
|
Serum Follicle Stimulating Hormone (FSH) Levels by Cycle Day
Cycle 2 - Day 4 (n=28, 28)
|
3.55 mIU/mL
Interval 1.2 to 9.5
|
3.70 mIU/mL
Interval 0.9 to 28.8
|
|
Serum Follicle Stimulating Hormone (FSH) Levels by Cycle Day
Cycle 2 - Day 6 (n=28, 27)
|
3.70 mIU/mL
Interval 0.4 to 8.5
|
3.50 mIU/mL
Interval 0.2 to 14.9
|
|
Serum Follicle Stimulating Hormone (FSH) Levels by Cycle Day
Cycle 2 - Days 19-20 (n=26, 28)
|
1.45 mIU/mL
Interval 0.2 to 5.7
|
1.55 mIU/mL
Interval 0.2 to 8.1
|
|
Serum Follicle Stimulating Hormone (FSH) Levels by Cycle Day
Cycle 2 - Day 23 (n=27, 28)
|
2.70 mIU/mL
Interval 0.2 to 6.3
|
2.35 mIU/mL
Interval 0.2 to 6.3
|
|
Serum Follicle Stimulating Hormone (FSH) Levels by Cycle Day
Cycle 2 - Day 24 (n=25, 28)
|
2.80 mIU/mL
Interval 0.2 to 8.0
|
3.70 mIU/mL
Interval 0.2 to 8.4
|
|
Serum Follicle Stimulating Hormone (FSH) Levels by Cycle Day
Cycle 2 - Day 25 (n=27, 28)
|
2.90 mIU/mL
Interval 0.2 to 8.0
|
3.90 mIU/mL
Interval 0.2 to 11.3
|
|
Serum Follicle Stimulating Hormone (FSH) Levels by Cycle Day
Cycle 2 - Day 27 (n=25, 28)
|
3.70 mIU/mL
Interval 0.2 to 9.6
|
3.90 mIU/mL
Interval 0.3 to 8.3
|
|
Serum Follicle Stimulating Hormone (FSH) Levels by Cycle Day
Cycle 2 - Day 28 (n=26, 28)
|
5.05 mIU/mL
Interval 0.2 to 11.0
|
4.70 mIU/mL
Interval 0.4 to 25.8
|
|
Serum Follicle Stimulating Hormone (FSH) Levels by Cycle Day
Cycle 3 - Day 2 (n=27, 28)
|
4.90 mIU/mL
Interval 0.2 to 9.8
|
4.05 mIU/mL
Interval 0.2 to 10.2
|
|
Serum Follicle Stimulating Hormone (FSH) Levels by Cycle Day
Cycle 3 - Day 4 (n=27, 28)
|
3.70 mIU/mL
Interval 0.2 to 8.0
|
3.60 mIU/mL
Interval 0.2 to 8.1
|
|
Serum Follicle Stimulating Hormone (FSH) Levels by Cycle Day
Cycle 3 - Day 6 (n=24, 26)
|
2.50 mIU/mL
Interval 0.6 to 7.1
|
2.50 mIU/mL
Interval 0.2 to 8.8
|
PRIMARY outcome
Timeframe: Cycle 2, Day 2 (Baseline), and Days 4, 6, 19-20, 23, 24, 25, 27, 28, Cycle 3, Days 2, 4 and 6.Population: Intent-to-treat population with available data at each time point (as indicated by n).
Levels of inhibin-B were measured throughout the study from blood samples.
Outcome measures
| Measure |
DR-1021
n=28 Participants
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).
|
Mircette
n=28 Participants
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).
|
|---|---|---|
|
Serum Inhibin-B Levels by Cycle Day
Cycle 2 - Day 2 (n=28, 28)
|
92.30 pg/mL
Interval 3.5 to 157.9
|
99.00 pg/mL
Interval 37.0 to 460.7
|
|
Serum Inhibin-B Levels by Cycle Day
Cycle 2 - Day 4 (n=28, 28)
|
42.80 pg/mL
Interval 13.3 to 128.9
|
64.45 pg/mL
Interval 15.9 to 197.0
|
|
Serum Inhibin-B Levels by Cycle Day
Cycle 2 - Day 6 (n=28, 27)
|
46.35 pg/mL
Interval 3.5 to 186.9
|
41.20 pg/mL
Interval 12.7 to 207.5
|
|
Serum Inhibin-B Levels by Cycle Day
Cycle 2 - Days 19-20 (n=26, 28)
|
23.15 pg/mL
Interval 3.5 to 203.4
|
28.85 pg/mL
Interval 3.5 to 159.3
|
|
Serum Inhibin-B Levels by Cycle Day
Cycle 2 - Day 23 (n=27, 28)
|
28.10 pg/mL
Interval 3.5 to 159.3
|
32.15 pg/mL
Interval 3.5 to 170.8
|
|
Serum Inhibin-B Levels by Cycle Day
Cycle 2 - Day 24 (n=25, 28)
|
36.80 pg/mL
Interval 3.5 to 142.8
|
55.00 pg/mL
Interval 3.5 to 200.0
|
|
Serum Inhibin-B Levels by Cycle Day
Cycle 2 - Day 25 (n=27, 28)
|
35.20 pg/mL
Interval 3.5 to 148.5
|
62.30 pg/mL
Interval 3.5 to 156.7
|
|
Serum Inhibin-B Levels by Cycle Day
Cycle 2 - Day 27 (n=25, 28)
|
39.60 pg/mL
Interval 3.5 to 152.6
|
49.20 pg/mL
Interval 3.5 to 127.6
|
|
Serum Inhibin-B Levels by Cycle Day
Cycle 2 - Day 28 (n=26, 28)
|
41.95 pg/mL
Interval 3.5 to 149.8
|
55.05 pg/mL
Interval 3.5 to 160.2
|
|
Serum Inhibin-B Levels by Cycle Day
Cycle 3 - Day 2 (n=27, 28)
|
54.70 pg/mL
Interval 3.5 to 136.5
|
57.95 pg/mL
Interval 3.5 to 162.3
|
|
Serum Inhibin-B Levels by Cycle Day
Cycle 3 - Day 4 (n=27, 28)
|
51.10 pg/mL
Interval 3.5 to 122.1
|
52.25 pg/mL
Interval 3.5 to 183.6
|
|
Serum Inhibin-B Levels by Cycle Day
Cycle 3 - Day 6 (n=24, 26)
|
36.15 pg/mL
Interval 3.5 to 211.7
|
29.55 pg/mL
Interval 3.5 to 141.4
|
SECONDARY outcome
Timeframe: Cycle 1, Days 11, 19-20, 23, 25, 27, Cycle 2, Days 4, 11, 19-20, 23, 25, 27, Cycle 3, Day 4.Population: Intent-to-treat
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).
Outcome measures
| Measure |
DR-1021
n=28 Participants
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).
|
Mircette
n=28 Participants
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).
|
|---|---|---|
|
Percentage of Follicles Greater Than 5 mm in Diameter
Cycle 1 - Day 11 (n=63, 48)
|
30.2 percentage of follicles
|
29.2 percentage of follicles
|
|
Percentage of Follicles Greater Than 5 mm in Diameter
Cycle 1 - Day 19-20 (n= 47, 94)
|
29.8 percentage of follicles
|
27.7 percentage of follicles
|
|
Percentage of Follicles Greater Than 5 mm in Diameter
Cycle 1 - Day 23 (n= 30, 76)
|
50.0 percentage of follicles
|
26.3 percentage of follicles
|
|
Percentage of Follicles Greater Than 5 mm in Diameter
Cycle 1 - Day 25 (n= 85, 106)
|
32.9 percentage of follicles
|
31.1 percentage of follicles
|
|
Percentage of Follicles Greater Than 5 mm in Diameter
Cycle 1 - Day 27 (n=135, 145)
|
29.6 percentage of follicles
|
35.2 percentage of follicles
|
|
Percentage of Follicles Greater Than 5 mm in Diameter
Cycle 2 - Day 4 (n=154, 156)
|
35.1 percentage of follicles
|
31.4 percentage of follicles
|
|
Percentage of Follicles Greater Than 5 mm in Diameter
Cycle 2 - Day 11 (n=76, 54)
|
27.6 percentage of follicles
|
31.5 percentage of follicles
|
|
Percentage of Follicles Greater Than 5 mm in Diameter
Cycle 2 - Days 19-20 (n=143, 148)
|
17.5 percentage of follicles
|
18.9 percentage of follicles
|
|
Percentage of Follicles Greater Than 5 mm in Diameter
Cycle 2 - Day 23 (n=91, 62)
|
24.2 percentage of follicles
|
24.2 percentage of follicles
|
|
Percentage of Follicles Greater Than 5 mm in Diameter
Cycle 2 - Day 25 (n=69, 80)
|
30.4 percentage of follicles
|
18.8 percentage of follicles
|
|
Percentage of Follicles Greater Than 5 mm in Diameter
Cycle 2 - Day 27 (n=94, 132)
|
23.4 percentage of follicles
|
20.5 percentage of follicles
|
|
Percentage of Follicles Greater Than 5 mm in Diameter
Cycle 3 - Day 4 (n=138, 117)
|
25.4 percentage of follicles
|
27.4 percentage of follicles
|
SECONDARY outcome
Timeframe: Cycle 2, Days 1-20 and Cycle 2, Days 21-28Population: Intent-to-treat population with available data.
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.
Outcome measures
| Measure |
DR-1021
n=18 Participants
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).
|
Mircette
n=18 Participants
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).
|
|---|---|---|
|
Change From Cycle 2 Days 1 - 20 to Cycle 2 Days 21 - 28 in Maximum Follicle Size
|
-2.02 mm
Standard Deviation 6.076
|
-1.79 mm
Standard Deviation 3.081
|
SECONDARY outcome
Timeframe: Cycle 2, Days 1-21, Cycle 2, Days 22-28 and Cycle 3, Days 1-21Population: Intent-to-treat
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.
Outcome measures
| Measure |
DR-1021
n=28 Participants
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).
|
Mircette
n=28 Participants
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).
|
|---|---|---|
|
Number of Days of Bleeding or Spotting During Unscheduled and Scheduled Study Periods
Cycle 2 - Unscheduled (Day 1-21)
|
2.19 days
Standard Deviation 3.732
|
1.41 days
Standard Deviation 1.551
|
|
Number of Days of Bleeding or Spotting During Unscheduled and Scheduled Study Periods
Cycle 2 - Scheduled (Day 22-28)
|
3.19 days
Standard Deviation 2.167
|
3.67 days
Standard Deviation 1.754
|
|
Number of Days of Bleeding or Spotting During Unscheduled and Scheduled Study Periods
Cycle 3 - Unscheduled (Day 1-21)
|
1.96 days
Standard Deviation 2.808
|
1.64 days
Standard Deviation 2.614
|
SECONDARY outcome
Timeframe: Cycle 2, Days 1-21, Cycle 2, Days 22-28 and Cycle 3, Days 1-21Population: Intent-to-treat
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.
Outcome measures
| Measure |
DR-1021
n=28 Participants
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).
|
Mircette
n=28 Participants
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).
|
|---|---|---|
|
Percentage of Participants With Bleeding or Spotting During Unscheduled and Scheduled Study Periods
Cycle 2 - Unscheduled (Day 1-21)
|
48.1 percentage of participants
|
59.3 percentage of participants
|
|
Percentage of Participants With Bleeding or Spotting During Unscheduled and Scheduled Study Periods
Cycle 2 - Scheduled (Day 22-28)
|
77.8 percentage of participants
|
92.6 percentage of participants
|
|
Percentage of Participants With Bleeding or Spotting During Unscheduled and Scheduled Study Periods
Cycle 3 - Unscheduled (Day 1-21)
|
55.6 percentage of participants
|
53.6 percentage of participants
|
SECONDARY outcome
Timeframe: Cycle 2, Days 1-21, Cycle 2, Days 22-28 and Cycle 3, Days 1-21Population: Intent-to-treat
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.
Outcome measures
| Measure |
DR-1021
n=28 Participants
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).
|
Mircette
n=28 Participants
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).
|
|---|---|---|
|
Number of Days of Bleeding During Unscheduled and Scheduled Study Periods
Cycle 2 - Unscheduled (Day 1-21)
|
0.70 days
Standard Deviation 2.127
|
0.52 days
Standard Deviation 0.935
|
|
Number of Days of Bleeding During Unscheduled and Scheduled Study Periods
Cycle 2 - Scheduled (Day 22-28)
|
2.30 days
Standard Deviation 1.793
|
2.63 days
Standard Deviation 1.843
|
|
Number of Days of Bleeding During Unscheduled and Scheduled Study Periods
Cycle 3 - Unscheduled (Day 1-21)
|
0.70 days
Standard Deviation 1.436
|
0.71 days
Standard Deviation 1.607
|
SECONDARY outcome
Timeframe: Cycle 2, Days 1-21, Cycle 2, Days 22-28 and Cycle 3, Days 1-21Population: Intent-to-treat
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.
Outcome measures
| Measure |
DR-1021
n=28 Participants
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).
|
Mircette
n=28 Participants
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).
|
|---|---|---|
|
Percentage of Participants With Bleeding During Unscheduled and Scheduled Study Periods
Cycle 2 - Unscheduled (Day 1-21)
|
18.5 percentage of participants
|
33.3 percentage of participants
|
|
Percentage of Participants With Bleeding During Unscheduled and Scheduled Study Periods
Cycle 2 - Scheduled (Day 22-28)
|
77.8 percentage of participants
|
77.8 percentage of participants
|
|
Percentage of Participants With Bleeding During Unscheduled and Scheduled Study Periods
Cycle 3 - Unscheduled (Day 1-21)
|
29.6 percentage of participants
|
25.0 percentage of participants
|
Adverse Events
DR-1021
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Mircette
Serious events: 1 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
DR-1021
n=28 participants at risk
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).
|
Mircette
n=28 participants at risk
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).
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/28 • From the date of the first randomized dose through 14 days after the last randomized dose, up to 42 days.
|
3.6%
1/28 • Number of events 1 • From the date of the first randomized dose through 14 days after the last randomized dose, up to 42 days.
|
Other adverse events
| Measure |
DR-1021
n=28 participants at risk
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).
|
Mircette
n=28 participants at risk
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).
|
|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/28 • From the date of the first randomized dose through 14 days after the last randomized dose, up to 42 days.
|
7.1%
2/28 • Number of events 2 • From the date of the first randomized dose through 14 days after the last randomized dose, up to 42 days.
|
|
Infections and infestations
Upper respiratory tract infection
|
3.6%
1/28 • Number of events 1 • From the date of the first randomized dose through 14 days after the last randomized dose, up to 42 days.
|
14.3%
4/28 • Number of events 4 • From the date of the first randomized dose through 14 days after the last randomized dose, up to 42 days.
|
|
Infections and infestations
Urinary tract infection
|
7.1%
2/28 • Number of events 2 • From the date of the first randomized dose through 14 days after the last randomized dose, up to 42 days.
|
0.00%
0/28 • From the date of the first randomized dose through 14 days after the last randomized dose, up to 42 days.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
7.1%
2/28 • Number of events 2 • From the date of the first randomized dose through 14 days after the last randomized dose, up to 42 days.
|
0.00%
0/28 • From the date of the first randomized dose through 14 days after the last randomized dose, up to 42 days.
|
|
Nervous system disorders
Headache
|
0.00%
0/28 • From the date of the first randomized dose through 14 days after the last randomized dose, up to 42 days.
|
7.1%
2/28 • Number of events 2 • From the date of the first randomized dose through 14 days after the last randomized dose, up to 42 days.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
7.1%
2/28 • Number of events 2 • From the date of the first randomized dose through 14 days after the last randomized dose, up to 42 days.
|
3.6%
1/28 • Number of events 1 • From the date of the first randomized dose through 14 days after the last randomized dose, up to 42 days.
|
Additional Information
Director of Clinical Research
Teva Branded Pharmaceutical Products R&D
Phone: 610-786-7047
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER