NCT00120913

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
160

participants targeted

Target at P75+ for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Completion

Last participant's last visit for all outcomes

August 1, 2004

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

July 12, 2005

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 19, 2005

Completed
Last Updated

July 19, 2005

Status Verified

July 1, 2005

First QC Date

July 12, 2005

Last Update Submit

July 18, 2005

Conditions

Breakthrough Bleeding

Keywords

Breakthrough bleeding while taking continuously dosed oral contraceptives

Outcome Measures

Primary Outcomes (1)

  • Bleeding patterns

Secondary Outcomes (1)

  • Satisfaction, menstrual-associated symptoms

Interventions

Birth control pillsDRUG

Eligibility Criteria

Age18 Years - 49 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

OHSU

Portland, Oregon, 97239, United States

Location

MeSH Terms

Conditions

Metrorrhagia

Interventions

Contraceptives, Oral

Condition Hierarchy (Ancestors)

Uterine HemorrhageUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Contraceptive Agents, FemaleContraceptive AgentsReproductive Control AgentsPhysiological Effects of DrugsPharmacologic ActionsChemical Actions and UsesTherapeutic Uses

Study Officials

  • Alison B Edelman, MD, MPH

    Oregon Health and Science University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 12, 2005

First Posted

July 19, 2005

Study Completion

August 1, 2004

Last Updated

July 19, 2005

Record last verified: 2005-07

Locations

US(1)