drugset / Trial / NCT00754065
To Compare SH T00658ID Over Ortho Tri-Cyclen Lo (US/Canada)
RandomizedParallel-groupDouble-blindTreatment
Summary
The objective of the study is to compare the oral contraceptive (OC) SH T00658ID over Ortho Tri-Cyclen Lo administered for 13 cycles to healthy female volunteers between 18 and 50 years of age who request oral contraceptive protection. Subjects on a levonorgestrel (LNG), norgestimate (NGM), norethindrone or norethindrone acetate containing oral contraceptive in a 21-day regimen suffering from hormone withdrawal-associated symptoms such as pelvic pain or headache or both, and willing to continue OC use but to switch to SH T00658ID or Ortho Tri-Cyclen Lo.
Timeline
- Start
- 2008-09-08
- Primary completion
- 2011-05-10
- Completion
- 2011-05-10
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Dienogest | Small molecule | 3 mg | Oral |
| Comparator | Norgestimate | Small molecule | 0.215 mg | Oral |
| Subject | estradiol valerate | Unknown | 2 mg | Oral |
| Comparator | ethinyl estradiol | Small molecule | 0.025 mg | Oral |
Indications
No indication recorded.