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An Open Label Study to Evaluate Cycle Control With Ortho Tri-Cyclen Lo (Norgestimate/Ethinyl Estradiol) and Yaz (Drospirenone/Ethinyl Estradiol) in Healthy Sexually Active Females
The purpose of this study in healthy sexually active females is to evaluate the cycle control with norgestimate/ethinyl estradiol versus drospirenone/ethinyl estradiol.
Details
| Lead sponsor | Ortho-McNeil Janssen Scientific Affairs, LLC |
|---|---|
| Phase | Phase 4 |
| Status | COMPLETED |
| Enrolment | 355 |
| Start date | 2008-05 |
| Completion | 2008-10 |
Conditions
- Contraception
Interventions
- Norgestimate/ethinyl estradiol; Drospirenone/ethinyl estradiol
Primary outcomes
- Number of Days of Unscheduled Blood Loss - Cycle 1 — Cycle 1 (Day 8 to 21 for NGM/25mcg EE and day 8 to 24 for DRSP/20mcg EE)
cycle control between treatment groups, cycle 1. Cycle control includes number of days of blood loss, incidence of blood loss, number of blood loss episodes, and blood loss flow intensity. Unscheduled bleeding is any bleeding during active pills except days 1-4 of cycle 2 or 3 if contiguous with withdrawal bleeding and days 1-7 of the first cycle. - Number of Days of Unscheduled Blood Loss - Cycle 2 — Cycle 2 (Day 29 to 49 for NGM/25mcg EE and day 29 to 52 for DRSP/20mcg EE)
cycle control between treatment groups, cycle 2. Cycle control includes number of days of blood loss, incidence of blood loss, number of blood loss episodes, and blood loss flow intensity. Unscheduled bleeding is any bleeding during active pills except days 1-4 of cycle 2 or 3 if contiguous with withdrawal bleeding and days 1-7 of the first cycle. - Number of Days of Unscheduled Blood Loss - Cycle 3 — Cycle 3 (Day 57 to 77 for NGM/25mcg EE and day 57 to 80 for DRSP/20mcg EE)
Number of Days of Unscheduled Blood Loss - Cycle 3. Cycle control includes number of days of blood loss, incidence of blood loss, number of blood loss episodes, and blood loss flow intensity. Unscheduled bleeding is any bleeding during active pills except days 1-4 of cycle 2 or 3 if contiguous with withdrawal bleeding and days 1-7 of the first cycle. - Overall Number of Days of Unscheduled Blood Loss — Cycle 1 to Cycle 3 (Day 8 to Day 80)
cycle control between treatment groups, for three 28-day cycles. Cycle control includes number of days of blood loss, incidence of blood loss, number of blood loss episodes, and blood loss flow intensity. Unscheduled bleeding is any bleeding during active pills except days 1-4 of cycle 2 or 3 if contiguous with withdrawal bleeding and days 1-7 of the first cycle. - Number of Participants With the Indicated Number of Unscheduled Blood Loss Episodes — Cycle 1 to Cycle 3 (Day 8 to Day 80)
Unscheduled blood loss episodes are bounded on both sides by at least 1 non- bleeding day. - Number of Days of Scheduled Blood Loss - Cycle 1 — Cycle 1 (Day 22 to 32 for NGM/25mcg EE and day 25 to 32 for DRSP/20mcg EE)
cycle control between treatment groups, cycle 1. Cycle control includes number of days of blood loss, incidence of blood loss, number of blood loss episodes, and blood loss flow intensity. Scheduled bleeding was defined as any bleeding that occurred while not taking active hormones, regardless of the duration of regimen.