Continuous Oral Contraceptives (COCs): Are Bleeding Patterns Dependent on the Hormones Given?

Breakthrough Bleeding Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00120913
• Other study ID #: OHSU IRB 7198
• Status: Completed
• Phase: N/A
• First received: July 12, 2005
• Last updated: July 18, 2005
• Est. completion date: August 2004

Study information

• Verified date: July 2005
• Source: Oregon Health and Science University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: August 2004
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 49 Years

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Breakthrough Bleeding
• Hemorrhage
• Metrorrhagia

Intervention

Drug:
• Birth control pills

Locations

Country	Name	City	State
United States	OHSU	Portland	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
Oregon Health and Science University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bleeding patterns
Secondary	Satisfaction, menstrual-associated symptoms