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

This study has been completed.

Sponsor:

ClinicalTrials.gov Identifier:

NCT00120913

First Posted: July 19, 2005

Last Update Posted: December 9, 2005

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Information provided by:

Oregon Health and Science University

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


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Single Group Assignment Masking: Double Primary Purpose: Prevention

Resource links provided by NLM:

MedlinePlus related topics: Bleeding

U.S. FDA Resources

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:	18 Years to 49 Years (Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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


ClinicalTrials.gov Identifier:	NCT00120913 History of Changes
Other Study ID Numbers:	OHSU IRB 7198
First Submitted:	July 12, 2005
First Posted:	July 19, 2005
Last Update Posted:	December 9, 2005
Last Verified:	July 2005

Keywords provided by Oregon Health and Science University:


Breakthrough bleeding while taking continuously dosed oral contraceptives

Additional relevant MeSH terms:


Hemorrhage Metrorrhagia Pathologic Processes Uterine Hemorrhage Uterine Diseases Genital Diseases, Female	Contraceptive Agents Contraceptives, Oral Contraceptives, Oral, Combined Reproductive Control Agents Physiological Effects of Drugs Contraceptive Agents, Female

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