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

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

July 12, 2005

Last Updated Date

July 18, 2005

Start Date ^†

Current Primary Outcome Measures ^†

Bleeding patterns

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00120913 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

Satisfaction, menstrual-associated symptoms

Original Secondary Outcome Measures ^†

Same as current

Descriptive Information

Brief Title ^†

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

Official Title ^†

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.

Detailed Description

Study Phase

Study Type ^†

Interventional

Study Design ^†

Prevention, Randomized, Double-Blind, Active Control, Single Group Assignment

Condition ^†

Breakthrough Bleeding

Intervention ^†

Drug: Birth control pills

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Completed

Enrollment ^†

160

Completion Date

August 2004

Primary Completion Date

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.

Gender

Female

Ages

18 Years to 49 Years

Accepts Healthy Volunteers

Yes

Contacts ^††

Location Countries ^†

United States

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00120913

Responsible Party

Secondary IDs ^††

Study Sponsor ^†

Oregon Health and Science University

Collaborators ^††

Investigators ^†

Principal Investigator:

Alison B Edelman, MD, MPH

Oregon Health and Science University

Information Provided By

Oregon Health and Science University

Verification Date

July 2005

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.