Breakthrough Bleeding
Conditions
Keywords
Breakthrough bleeding while taking continuously dosed oral contraceptives
Brief summary
While there may be a decrease in the total number of bleeding days women experience with continuous-dosed COCs (no menstrual withdrawal week), these regimens frequently result in an increased number of breakthrough or non-scheduled bleeding days. Breakthrough bleeding is among the main reasons cited for discontinuation of combined COCs dosed traditionally (3 weeks of active pill, 1 week of placebo) or continuously, and may offset the perceived benefit of fewer withdrawal bleeding events for many women taking continuous-dosed COCs. The exact mechanisms responsible for breakthrough bleeding patterns during hormonal contraception are unknown and may be related to the pill formulation. This study is to determine whether progestin type or estrogen dose influences bleeding patterns, side effects, or satisfaction with combined oral contraceptives (COC) dosed continuously.
Interventions
DRUGBirth control pills
Sponsors
Oregon Health and Science University
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
DOUBLE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 49 Years
Healthy volunteers
Yes
Inclusion criteria
* Age \> 18 to 49 years old * Good general health * No medical contraindications to combined COC therapy. * In addition, all participants were required to have taken cyclic COCs for at least three months at the time of enrollment, in order to avoid common transition bleeding with the initiation of COCs.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Bleeding patterns | — |
Secondary
| Measure | Time frame |
|---|---|
| Satisfaction, menstrual-associated symptoms | — |
Countries
United States
Outcome results
None listed