A Phase 3 interventional study of DR-1021 and Mircette® in Healthy, sponsored by Teva Branded Pharmaceutical Products R&D, Inc.. Completed at 4 sites in United States. Open to female participants aged 18 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-11-18.
Sponsored by Teva Branded Pharmaceutical Products R&D, Inc. · Phase 3, Interventional, and Treatment
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.
Teva Branded Pharmaceutical Products R&D, Inc. is the lead sponsor of 205 studies on the registry; none are open to participants now.
Of its 49 completed or terminated interventional studies of FDA-regulated products, 47 (96%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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 · Drug: Kariva®
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® · Drug: Kariva®
Twenty-one 150 μg desogestrel/20 μg ethinyl estradiol (EE) combination tablets plus seven 10 μg EE tablets.
Also known as: desogestrel/ethinyl estradiol
Twenty-one 150 μg desogestrel/20 μg ethinyl estradiol (EE) combination tablets plus two placebo tablets plus five 10 μg EE tablets.
Also known as: desogestrel/ethinyl estradiol
Twenty-one 150 μg desogestrel/20 μg ethinyl estradiol (EE) combination tablets plus two placebo tablets plus five 10 μg EE tablets.
Also known as: desogestrel/ethinyl estradiol
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.
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
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.
| Milestone | Run-In Cycle - All Enrolled | DR-1021 | Mircette |
|---|---|---|---|
| Started | 61 | 0 | 0 |
| Completed | 58 | 0 | 0 |
| Not completed | 3 | 0 | 0 |
| Withdrew: Withdrawal by subject | 2 | 0 | 0 |
| Withdrew: Adverse event | 1 | 0 | 0 |
| Milestone | Run-In Cycle - All Enrolled | DR-1021 | Mircette |
|---|---|---|---|
| Started | 0 | 29 | 29 |
| Treated | 0 | 28 | 28 |
| Completed | 0 | 28 | 28 |
| Not completed | 0 | 1 | 1 |
| Withdrew: Withdrawal by subject | 0 | 1 | 0 |
| Withdrew: Noncompliance | 0 | 0 | 1 |
| Milestone | Run-In Cycle - All Enrolled | DR-1021 | Mircette |
|---|---|---|---|
| Started | 0 | 28 | 28 |
| Completed | 0 | 26 | 28 |
| Not completed | 0 | 2 | 0 |
| Withdrew: Noncompliance | 0 | 1 | 0 |
| Withdrew: Pregnancy | 0 | 1 | 0 |
Levels of estradiol were measured throughout the study from blood samples.
| pg/mL | DR-1021 | Mircette |
|---|---|---|
| Cycle 2 - Day 2 (n=28, 28) | 47.00 (15.0 to 361.0) | 51.50 (6.0 to 322.0) |
| Cycle 2 - Day 4 (n=28, 28) | 62.50 (1.0 to 613.0) | 34.50 (1.0 to 423.0) |
| Cycle 2 - Day 6 (n=27, 27) | 43.00 (1.0 to 579.0) | 29.00 (1.0 to 274.0) |
| Cycle 2 - Days 19-20 (n=26, 28) | 19.00 (1.0 to 152.0) | 20.50 (1.0 to 327.0) |
| Cycle 2 - Day 23 (n=27, 28) | 24.00 (1.0 to 204.0) | 19.00 (1.0 to 159.0) |
| Cycle 2 - Day 24 (n=25, 28) | 25.00 (1.0 to 289.0) | 26.50 (1.0 to 169.0) |
| Cycle 2 - Day 25 (n=27, 28) | 24.00 (1.0 to 169.0) | 26.00 (1.0 to 225.0) |
| Cycle 2 - Day 27 (n=25, 28) | 30.00 (1.0 to 233.0) | 20.00 (1.0 to 213.0) |
| Cycle 2 - Day 28 (n=26, 28) | 36.00 (1.0 to 284.0) | 27.50 (1.0 to 332.0) |
| Cycle 3 - Day 2 (n=27, 28) | 34.00 (1.0 to 425.0) | 43.00 (3.0 to 217.0) |
| Cycle 3 - Day 4 (n=27, 27) | 66.00 (1.0 to 440.0) | 27.00 (1.0 to 295.0) |
| Cycle 3 - Day 6 (n=24, 26) | 28.50 (1.0 to 277.0) | 32.00 (3.0 to 197.0) |
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).
| percentage of follicles | DR-1021 | Mircette |
|---|---|---|
| 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 |
Levels of follicle stimulating hormone were measured throughout the study from blood samples.
| mIU/mL | DR-1021 | Mircette |
|---|---|---|
| Cycle 2 - Day 2 (n=28, 28) | 4.00 (2.3 to 9.7) | 4.00 (1.2 to 7.1) |
| Cycle 2 - Day 4 (n=28, 28) | 3.55 (1.2 to 9.5) | 3.70 (0.9 to 28.8) |
| Cycle 2 - Day 6 (n=28, 27) | 3.70 (0.4 to 8.5) | 3.50 (0.2 to 14.9) |
| Cycle 2 - Days 19-20 (n=26, 28) | 1.45 (0.2 to 5.7) | 1.55 (0.2 to 8.1) |
| Cycle 2 - Day 23 (n=27, 28) | 2.70 (0.2 to 6.3) | 2.35 (0.2 to 6.3) |
| Cycle 2 - Day 24 (n=25, 28) | 2.80 (0.2 to 8.0) | 3.70 (0.2 to 8.4) |
| Cycle 2 - Day 25 (n=27, 28) | 2.90 (0.2 to 8.0) | 3.90 (0.2 to 11.3) |
| Cycle 2 - Day 27 (n=25, 28) | 3.70 (0.2 to 9.6) | 3.90 (0.3 to 8.3) |
| Cycle 2 - Day 28 (n=26, 28) | 5.05 (0.2 to 11.0) | 4.70 (0.4 to 25.8) |
| Cycle 3 - Day 2 (n=27, 28) | 4.90 (0.2 to 9.8) | 4.05 (0.2 to 10.2) |
| Cycle 3 - Day 4 (n=27, 28) | 3.70 (0.2 to 8.0) | 3.60 (0.2 to 8.1) |
| Cycle 3 - Day 6 (n=24, 26) | 2.50 (0.6 to 7.1) | 2.50 (0.2 to 8.8) |
Levels of inhibin-B were measured throughout the study from blood samples.
| pg/mL | DR-1021 | Mircette |
|---|---|---|
| Cycle 2 - Day 2 (n=28, 28) | 92.30 (3.5 to 157.9) | 99.00 (37.0 to 460.7) |
| Cycle 2 - Day 4 (n=28, 28) | 42.80 (13.3 to 128.9) | 64.45 (15.9 to 197.0) |
| Cycle 2 - Day 6 (n=28, 27) | 46.35 (3.5 to 186.9) | 41.20 (12.7 to 207.5) |
| Cycle 2 - Days 19-20 (n=26, 28) | 23.15 (3.5 to 203.4) | 28.85 (3.5 to 159.3) |
| Cycle 2 - Day 23 (n=27, 28) | 28.10 (3.5 to 159.3) | 32.15 (3.5 to 170.8) |
| Cycle 2 - Day 24 (n=25, 28) | 36.80 (3.5 to 142.8) | 55.00 (3.5 to 200.0) |
| Cycle 2 - Day 25 (n=27, 28) | 35.20 (3.5 to 148.5) | 62.30 (3.5 to 156.7) |
| Cycle 2 - Day 27 (n=25, 28) | 39.60 (3.5 to 152.6) | 49.20 (3.5 to 127.6) |
| Cycle 2 - Day 28 (n=26, 28) | 41.95 (3.5 to 149.8) | 55.05 (3.5 to 160.2) |
| Cycle 3 - Day 2 (n=27, 28) | 54.70 (3.5 to 136.5) | 57.95 (3.5 to 162.3) |
| Cycle 3 - Day 4 (n=27, 28) | 51.10 (3.5 to 122.1) | 52.25 (3.5 to 183.6) |
| Cycle 3 - Day 6 (n=24, 26) | 36.15 (3.5 to 211.7) | 29.55 (3.5 to 141.4) |
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.
| mm | DR-1021 | Mircette |
|---|---|---|
| Change From Cycle 2 Days 1 - 20 to Cycle 2 Days 21 - 28 in Maximum Follicle Size | -2.02 ± 6.076 | -1.79 ± 3.081 |
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.
| days | DR-1021 | Mircette |
|---|---|---|
| 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 |
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.
| percentage of participants | DR-1021 | Mircette |
|---|---|---|
| Cycle 2 - Unscheduled (Day 1-21) | 48.1 | 59.3 |
| Cycle 2 - Scheduled (Day 22-28) | 77.8 | 92.6 |
| Cycle 3 - Unscheduled (Day 1-21) | 55.6 | 53.6 |
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.
| days | DR-1021 | Mircette |
|---|---|---|
| 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 |
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.
| percentage of participants | DR-1021 | Mircette |
|---|---|---|
| Cycle 2 - Unscheduled (Day 1-21) | 18.5 | 33.3 |
| Cycle 2 - Scheduled (Day 22-28) | 77.8 | 77.8 |
| Cycle 3 - Unscheduled (Day 1-21) | 29.6 | 25.0 |
Collected over From the date of the first randomized dose through 14 days after the last randomized dose, up to 42 days.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| DR-1021 | — | 0/28 (0%) | 7/28 (25%) |
| Mircette | — | 1/28 (3.6%) | 7/28 (25%) |
| Event | DR-1021 | Mircette |
|---|---|---|
| AsthmaRespiratory, thoracic and mediastinal disorders | 0/28 | 1/28 |
| Event | DR-1021 | Mircette |
|---|---|---|
| Upper respiratory tract infectionInfections and infestations | 1/28 | 4/28 |
| NasopharyngitisInfections and infestations | 0/28 | 2/28 |
| Urinary tract infectionInfections and infestations | 2/28 | 0/28 |
| Back painMusculoskeletal and connective tissue disorders | 2/28 | 0/28 |
| HeadacheNervous system disorders | 0/28 | 2/28 |
| Nasal congestionRespiratory, thoracic and mediastinal disorders | 2/28 | 1/28 |
The Intent-to-treat (ITT) cohort consisted of all randomized participants who took at least one dose of randomized study medication and had at least one post-baseline efficacy measurement for at least one of the primary efficacy endpoints (FSH, inhibin-B, or estradiol).
| Age, Continuous(years) | DR-1021 | Mircette | Total |
|---|---|---|---|
| Mean | 27.3 ± 4.68 | 28.0 ± 4.38 | 27.7 ± 4.51 |
| Sex: Female, Male(Participants) | DR-1021 | Mircette | Total |
|---|---|---|---|
| Female | 28 | 28 | 56 |
| Male | 0 | 0 | 0 |
| Race/Ethnicity, Customized(participants) | DR-1021 | Mircette | Total |
|---|---|---|---|
| African-American | 4 | 6 | 10 |
| Asian | 2 | 0 | 2 |
| Caucasian | 20 | 20 | 40 |
| Hispanic | 1 | 1 | 2 |
| Other | 1 | 1 | 2 |
| Region of Enrollment(participants) | DR-1021 | Mircette | Total |
|---|---|---|---|
| United States | 28 | 28 | 56 |
This study is completed, as verified in Nov 2021. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Teva Branded Pharmaceutical Products R&D, Inc.