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OpenTrials
Completed

NCT Number: NCT00120913

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

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.

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Key information

Conditions

Breakthrough Bleeding Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Hemorrhage Metrorrhagia Pathologic Processes Pathological Conditions, Signs and Symptoms Urogenital Diseases Uterine Diseases Uterine Hemorrhage

Age range

18 year–49 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

OHSU

Portland, Oregon, 97239, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Birth control pills

Drug

Primary outcomes

  1. Bleeding patterns

Secondary outcomes

  1. Satisfaction, menstrual-associated symptoms

Sponsors and collaborators

Lead sponsor

Oregon Health and Science University

Other

Registry information

Important dates

Study completion
2004
First posted
Jul 19, 2005
Registry last updated
Jul 19, 2005

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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