drugset / Trial / NCT00344383
An Open-Label Study Evaluating Breakthrough Bleeding and Spotting With Norgestimate/Ethinyl Estradiol Tablets Administered as an Extended Regimen
Phase 2
Completed
61 enrolled
McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.
Non-randomizedSingle-groupOpen-labelTreatment
Summary
The purpose of this study is to evaluate the bleeding profile of norgestimate/ethinyl estradiol, an oral contraceptive tablet, given in an extended regimen
Timeline
- Start
- 2003-11
- Primary completion
- —
- Completion
- 2004-07
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Norgestimate | Small molecule | 180 ug | Oral |
| Subject | Norgestimate | Small molecule | 215 ug | Oral |
| Subject | Norgestimate | Small molecule | 250 ug | Oral |
| Subject | ethinyl estradiol | Small molecule | 25 ug | Oral |