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An Open-Label Study Evaluating the Bleeding Profile of Ortho Tri-Cyclen Lo (Norgestimate/Ethinyl Estradiol) Administered as an Extended Regimen
The purpose of this study is to evaluate the bleeding profile of norgestimate/ethinyl estradiol, an oral contraceptive tablet, given in an extended regimen
Details
| Lead sponsor | McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc. |
|---|---|
| Phase | Phase 2 |
| Status | COMPLETED |
| Enrolment | 61 |
| Start date | 2003-11 |
| Completion | 2004-07 |
Conditions
- Metrorrhagia
Interventions
- Norgestimate/Ethinyl Estradiol tablet
Primary outcomes
- The primary efficacy variables include the number of breakthrough bleeding and/or spotting days during the extended regimen treatment phase and the number of breakthrough bleeding days during the extended regimen treatment phase.