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
4
2
5
15.3
3.1
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 Disease | Intervention/Treatment | Phase |
|---|---|---|
| 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
| Arm | Intervention/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:
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:
|
| 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:
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:
|
Outcome Measures
Primary Outcome Measures
- 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.
- 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.
- 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
- 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).
- 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.
- 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.
- 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.
- 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.
- 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
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Duramed Investigational Site | Lawrenceville | New Jersey | United States | 08648 |
| 2 | Duramed Investigational Site | Columbus | Ohio | United States | 43213 |
| 3 | Duramed Investigational Site | Philadelphia | Pennsylvania | United States | 19114 |
| 4 | Duramed Investigational Site | Seattle | Washington | United States | 98105 |
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
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | 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. |
|---|---|
| Pre-assignment Detail | 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. |
| Arm/Group Title | Run-In Cycle - All Enrolled | DR-1021 | Mircette |
|---|---|---|---|
| Arm/Group Description | 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. | 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 | |||
| STARTED | 61 | 0 | 0 |
| COMPLETED | 58 | 0 | 0 |
| NOT COMPLETED | 3 | 0 | 0 |
| Period Title: Cycle 1: Run-in Cycle | |||
| STARTED | 0 | 29 | 29 |
| Treated | 0 | 28 | 28 |
| COMPLETED | 0 | 28 | 28 |
| NOT COMPLETED | 0 | 1 | 1 |
| Period Title: Cycle 1: Run-in Cycle | |||
| STARTED | 0 | 28 | 28 |
| COMPLETED | 0 | 26 | 28 |
| NOT COMPLETED | 0 | 2 | 0 |
Baseline Characteristics
| Arm/Group Title | DR-1021 | Mircette | Total |
|---|---|---|---|
| Arm/Group Description | 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). | Total of all reporting groups |
| Overall Participants | 28 | 28 | 56 |
| 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
| Title | Serum Estradiol Levels by Cycle Day |
|---|---|
| Description | 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. |
Outcome Measure Data
| Analysis Population Description |
|---|
| Intent-to-treat population with available data at each time point (as indicated by n). |
| Arm/Group Title | DR-1021 | Mircette |
|---|---|---|
| Arm/Group Description | 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). |
| Measure Participants | 28 | 28 |
| 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 Hypothesis | p-Value | 0.6346 |
| Comments | ||
| Method | Wilcoxon (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 Hypothesis | p-Value | 0.2757 |
| Comments | ||
| Method | Wilcoxon (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 Hypothesis | p-Value | 0.1321 |
| Comments | ||
| Method | Wilcoxon (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 Hypothesis | p-Value | 0.5543 |
| Comments | ||
| Method | Wilcoxon (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 Hypothesis | p-Value | 0.3940 |
| Comments | ||
| Method | Wilcoxon (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 Hypothesis | p-Value | 0.7891 |
| Comments | ||
| Method | Wilcoxon (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 Hypothesis | p-Value | 0.4829 |
| Comments | ||
| Method | Wilcoxon (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 Hypothesis | p-Value | 0.4526 |
| Comments | ||
| Method | Wilcoxon (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 Hypothesis | p-Value | 0.2485 |
| Comments | ||
| Method | Wilcoxon (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 Hypothesis | p-Value | 0.6252 |
| Comments | ||
| Method | Wilcoxon (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 Hypothesis | p-Value | 0.4003 |
| Comments | ||
| Method | Wilcoxon (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 Hypothesis | p-Value | 0.8841 |
| Comments | ||
| Method | Wilcoxon (Mann-Whitney) | |
| Comments | ||
| Title | Percentage of Follicles Greater Than 5 mm in Diameter |
|---|---|
| Description | 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. |
Outcome Measure Data
| Analysis Population Description |
|---|
| Intent-to-treat |
| Arm/Group Title | DR-1021 | Mircette |
|---|---|---|
| Arm/Group Description | 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). |
| Measure Participants | 28 | 28 |
| 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
|
| Title | Serum Follicle Stimulating Hormone (FSH) Levels by Cycle Day |
|---|---|
| Description | 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. |
Outcome Measure Data
| Analysis Population Description |
|---|
| Intent-to-treat population with available data at each time point (as indicated by n). |
| Arm/Group Title | DR-1021 | Mircette |
|---|---|---|
| Arm/Group Description | 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). |
| Measure Participants | 28 | 28 |
| 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 Hypothesis | p-Value | 0.8892 |
| Comments | ||
| Method | Wilcoxon (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 Hypothesis | p-Value | 0.7678 |
| Comments | ||
| Method | Wilcoxon (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 Hypothesis | p-Value | 0.5782 |
| Comments | ||
| Method | Wilcoxon (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 Hypothesis | p-Value | 0.8083 |
| Comments | ||
| Method | Wilcoxon (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 Hypothesis | p-Value | 1.0000 |
| Comments | ||
| Method | Wilcoxon (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 Hypothesis | p-Value | 0.4122 |
| Comments | ||
| Method | Wilcoxon (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 Hypothesis | p-Value | 0.6675 |
| Comments | ||
| Method | Wilcoxon (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 Hypothesis | p-Value | 0.8445 |
| Comments | ||
| Method | Wilcoxon (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 Hypothesis | p-Value | 0.3772 |
| Comments | ||
| Method | Wilcoxon (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 Hypothesis | p-Value | 0.1918 |
| Comments | ||
| Method | Wilcoxon (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 Hypothesis | p-Value | 0.6675 |
| Comments | ||
| Method | Wilcoxon (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 Hypothesis | p-Value | 0.9226 |
| Comments | ||
| Method | Wilcoxon (Mann-Whitney) | |
| Comments | ||
| Title | Serum Inhibin-B Levels by Cycle Day |
|---|---|
| Description | 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. |
Outcome Measure Data
| Analysis Population Description |
|---|
| Intent-to-treat population with available data at each time point (as indicated by n). |
| Arm/Group Title | DR-1021 | Mircette |
|---|---|---|
| Arm/Group Description | 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). |
| Measure Participants | 28 | 28 |
| 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 Hypothesis | p-Value | 0.0979 |
| Comments | ||
| Method | Wilcoxon (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 Hypothesis | p-Value | 0.0629 |
| Comments | ||
| Method | Wilcoxon (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 Hypothesis | p-Value | 0.8464 |
| Comments | ||
| Method | Wilcoxon (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 Hypothesis | p-Value | 0.6316 |
| Comments | ||
| Method | Wilcoxon (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 Hypothesis | p-Value | 0.3000 |
| Comments | ||
| Method | Wilcoxon (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 Hypothesis | p-Value | 0.0955 |
| Comments | ||
| Method | Wilcoxon (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 Hypothesis | p-Value | 0.1523 |
| Comments | ||
| Method | Wilcoxon (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 Hypothesis | p-Value | 0.2809 |
| Comments | ||
| Method | Wilcoxon (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 Hypothesis | p-Value | 0.8829 |
| Comments | ||
| Method | Wilcoxon (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 Hypothesis | p-Value | 0.9262 |
| Comments | ||
| Method | Wilcoxon (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 Hypothesis | p-Value | 0.7811 |
| Comments | ||
| Method | Wilcoxon (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 Hypothesis | p-Value | 0.3703 |
| Comments | ||
| Method | Wilcoxon (Mann-Whitney) | |
| Comments | ||
| Title | Change From Cycle 2 Days 1 - 20 to Cycle 2 Days 21 - 28 in Maximum Follicle Size |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Intent-to-treat population with available data. |
| Arm/Group Title | DR-1021 | Mircette |
|---|---|---|
| Arm/Group Description | 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). |
| Measure Participants | 18 | 18 |
| Mean (Standard Deviation) [mm] |
-2.02
(6.076)
|
-1.79
(3.081)
|
| Title | Number of Days of Bleeding or Spotting During Unscheduled and Scheduled Study Periods |
|---|---|
| Description | 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. |
| Time Frame | Cycle 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 Title | DR-1021 | Mircette |
|---|---|---|
| Arm/Group Description | 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). |
| Measure Participants | 28 | 28 |
| 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)
|
| Title | Percentage of Participants With Bleeding or Spotting During Unscheduled and Scheduled Study Periods |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Intent-to-treat |
| Arm/Group Title | DR-1021 | Mircette |
|---|---|---|
| Arm/Group Description | 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). |
| Measure Participants | 28 | 28 |
| 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%
|
| Title | Number of Days of Bleeding During Unscheduled and Scheduled Study Periods |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Intent-to-treat |
| Arm/Group Title | DR-1021 | Mircette |
|---|---|---|
| Arm/Group Description | 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). |
| Measure Participants | 28 | 28 |
| 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)
|
| Title | Percentage of Participants With Bleeding During Unscheduled and Scheduled Study Periods |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Intent-to-treat |
| Arm/Group Title | DR-1021 | Mircette |
|---|---|---|
| Arm/Group Description | 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). |
| Measure Participants | 28 | 28 |
| 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 Frame | From 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 Title | DR-1021 | Mircette | ||
| Arm/Group Description | 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). | ||
All Cause Mortality |
||||
| DR-1021 | Mircette | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
| DR-1021 | Mircette | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/28 (0%) | 1/28 (3.6%) | ||
| Respiratory, thoracic and mediastinal disorders | ||||
| Asthma | 0/28 (0%) | 0 | 1/28 (3.6%) | 1 |
Other (Not Including Serious) Adverse Events |
||||
| DR-1021 | Mircette | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 7/28 (25%) | 7/28 (25%) | ||
| Infections and infestations | ||||
| Nasopharyngitis | 0/28 (0%) | 0 | 2/28 (7.1%) | 2 |
| Upper respiratory tract infection | 1/28 (3.6%) | 1 | 4/28 (14.3%) | 4 |
| Urinary tract infection | 2/28 (7.1%) | 2 | 0/28 (0%) | 0 |
| Musculoskeletal and connective tissue disorders | ||||
| Back pain | 2/28 (7.1%) | 2 | 0/28 (0%) | 0 |
| Nervous system disorders | ||||
| Headache | 0/28 (0%) | 0 | 2/28 (7.1%) | 2 |
| Respiratory, thoracic and mediastinal disorders | ||||
| Nasal congestion | 2/28 (7.1%) | 2 | 1/28 (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/Title | Director of Clinical Research |
|---|---|
| Organization | Teva Branded Pharmaceutical Products R&D |
| Phone | 610-786-7047 |
| clinicaltrialsdisclosure@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