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

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ClinicalTrials.gov Identifier: NCT00120913
Recruitment Status : Completed
First Posted : July 19, 2005
Last Update Posted : July 19, 2005
Sponsor:
Information provided by:
Oregon Health and Science University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Breakthrough Bleeding Drug: Birth control pills Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Prevention
Study Completion Date : August 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding

Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Bleeding patterns

Secondary Outcome Measures :
  1. Satisfaction, menstrual-associated symptoms

Eligibility Criteria
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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
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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
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United States, Oregon
OHSU
Portland, Oregon, United States, 97239
Sponsors and Collaborators
Oregon Health and Science University
Investigators
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Principal Investigator: Alison B Edelman, MD, MPH Oregon Health and Science University
More Information
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ClinicalTrials.gov Identifier: NCT00120913    
Other Study ID Numbers: OHSU IRB 7198
First Posted: July 19, 2005    Key Record Dates
Last Update Posted: July 19, 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:
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Metrorrhagia
Hemorrhage
Pathologic Processes
Uterine Hemorrhage
Uterine Diseases
Contraceptives, Oral
 Contraceptives, Oral, Combined
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs