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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:


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

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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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