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

Sponsored by:	Oregon Health and Science University
Information provided by:	Oregon Health and Science University
ClinicalTrials.gov Identifier:	NCT00120913

Purpose

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.

Condition	Intervention
Breakthrough Bleeding	Drug: Birth control pills

MedlinePlus related topics: Birth Control

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double-Blind, Active Control, Single Group Assignment

Further study details as provided by Oregon Health and Science University:

Primary Outcome Measures:

Bleeding patterns

Secondary Outcome Measures:

Satisfaction, menstrual-associated symptoms

Estimated Enrollment:	160
Estimated Study Completion Date:	August 2004

Eligibility

Ages Eligible for Study:	18 Years to 49 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00120913

Locations

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

Sponsors and Collaborators

Oregon Health and Science University

Investigators

Principal Investigator:

Alison B Edelman, MD, MPH

Oregon Health and Science University

More Information

Study ID Numbers:	OHSU IRB 7198
Study First Received:	July 12, 2005
Last Updated:	July 18, 2005
ClinicalTrials.gov Identifier:	NCT00120913
Health Authority:	United States: Institutional Review Board

Keywords provided by Oregon Health and Science University:

Breakthrough bleeding while taking continuously dosed oral contraceptives

Study placed in the following topic categories:

Genital Diseases, Female
Uterine Hemorrhage
Metrorrhagia
Uterine Diseases
Hemorrhage

Additional relevant MeSH terms:

Pathologic Processes

ClinicalTrials.gov processed this record on January 15, 2009