Phase 3
N=61
A Study to Evaluate Hormone Patterns and Ovarian Follicular Activity With DR-1021
Healthy
Bottom Line
View on ClinicalTrials.gov: NCT00544882 ↗Enrolled (actual)
61
Serious AEs
1.8%
Results posted
Jun 2014
Primary outcome: Primary: Serum Estradiol Levels by Cycle Day — 47.00; 51.50; 62.50; 34.50 pg/mL — p=0.6346
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- DR-1021 (Drug); Mircette® (Drug); Kariva® (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
- Primary completion
- Mar 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Serum Estradiol Levels by Cycle Day |
47.00; 51.50; 62.50; 34.50; 43.00; 29.00 | 0.6346 |
| PRIMARY Serum Follicle Stimulating Hormone (FSH) Levels by Cycle Day |
4.00; 4.00; 3.55; 3.70; 3.70; 3.50 | 0.8892 |
| PRIMARY Serum Inhibin-B Levels by Cycle Day |
92.30; 99.00; 42.80; 64.45; 46.35; 41.20 | 0.0979 |
| SECONDARY Percentage of Follicles Greater Than 5 mm in Diameter |
30.2; 29.2; 29.8; 27.7; 50.0; 26.3 | — |
| SECONDARY Change From Cycle 2 Days 1 - 20 to Cycle 2 Days 21 - 28 in Maximum Follicle Size |
-2.02; -1.79 | — |
| SECONDARY Number of Days of Bleeding or Spotting During Unscheduled and Scheduled Study Periods |
2.19; 1.41; 3.19; 3.67; 1.96; 1.64 | — |
| SECONDARY Percentage of Participants With Bleeding or Spotting During Unscheduled and Scheduled Study Periods |
48.1; 59.3; 77.8; 92.6; 55.6; 53.6 | — |
| SECONDARY Number of Days of Bleeding During Unscheduled and Scheduled Study Periods |
0.70; 0.52; 2.30; 2.63; 0.70; 0.71 | — |
| SECONDARY Percentage of Participants With Bleeding During Unscheduled and Scheduled Study Periods |
18.5; 33.3; 77.8; 77.8; 29.6; 25.0 | — |
Summary
This is a multi-center study to evaluate hormone levels with the oral contraceptive regimen DR-1021.
Eligibility Criteria
Inclusion Criteria
- Premenopausal
- Weight 10 cigarettes per day
- Use of drugs that require simultaneous use of contraceptives (e.g., isotretinoin [Accutane])
- Others as dictated by protocol
Data sourced from ClinicalTrials.gov (NCT00544882). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.