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

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.

Study Overview

• Status: Completed
• Conditions: Breakthrough Bleeding
• Intervention / Treatment: Drug: Birth control pills

• Study Type: Interventional
• Enrollment: 160
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Oregon
    • Portland, Oregon, United States, 97239
      • OHSU

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 49 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Bleeding patterns

Secondary Outcome Measures

Outcome Measure
Satisfaction, menstrual-associated symptoms

Collaborators and Investigators

• Sponsor: Oregon Health and Science University
• Investigators: Principal Investigator: Alison B Edelman, MD, MPH, Oregon Health and Science University

Study record dates

Study Major Dates

• Study Start: December 7, 2022
• Primary Completion: December 7, 2022
• Study Completion: August 1, 2004

Study Registration Dates

• First Submitted: July 12, 2005
• First Submitted That Met QC Criteria: July 18, 2005
• First Posted (Estimate): July 19, 2005

Study Record Updates

• Last Update Posted (Estimate): July 19, 2005
• Last Update Submitted That Met QC Criteria: July 18, 2005
• Last Verified: July 1, 2005

More Information

Terms related to this study

• Keywords: Breakthrough bleeding while taking continuously dosed oral contraceptives
• Additional Relevant MeSH Terms: Pathologic Processes; Uterine Diseases; Uterine Hemorrhage; Hemorrhage; Metrorrhagia; Physiological Effects of Drugs; Contraceptive Agents; Reproductive Control Agents; Contraceptive Agents, Female; Contraceptives, Oral; Contraceptives, Oral, Combined
• Other Study ID Numbers: OHSU IRB 7198

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No