Continuous Oral Contraceptives (COCs): Are Bleeding Patterns Dependent on the Hormones Given?
Primary Purpose
Breakthrough Bleeding
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Birth control pills
Sponsored by
About this trial
This is an interventional prevention trial for Breakthrough Bleeding focused on measuring Breakthrough bleeding while taking continuously dosed oral contraceptives
Eligibility Criteria
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.
Sites / Locations
- OHSU
Outcomes
Primary Outcome Measures
Bleeding patterns
Secondary Outcome Measures
Satisfaction, menstrual-associated symptoms
Full Information
NCT ID
NCT00120913
First Posted
July 12, 2005
Last Updated
July 18, 2005
Sponsor
Oregon Health and Science University
1. Study Identification
Unique Protocol Identification Number
NCT00120913
Brief Title
Continuous Oral Contraceptives (COCs): Are Bleeding Patterns Dependent on the Hormones Given?
Study Type
Interventional
2. Study Status
Record Verification Date
July 2005
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2004 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Oregon Health and Science University
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breakthrough Bleeding
Keywords
Breakthrough bleeding while taking continuously dosed oral contraceptives
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Double
Allocation
Randomized
Enrollment
160 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Birth control pills
Primary Outcome Measure Information:
Title
Bleeding patterns
Secondary Outcome Measure Information:
Title
Satisfaction, menstrual-associated symptoms
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
49 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alison B Edelman, MD, MPH
Organizational Affiliation
Oregon Health and Science University
Official's Role
Principal Investigator
Facility Information:
Facility Name
OHSU
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Continuous Oral Contraceptives (COCs): Are Bleeding Patterns Dependent on the Hormones Given?
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