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

• Sponsor: Oregon Health and Science University (Other)
• Overall Status: Completed
• CT.gov ID: NCT00120913
• Collaborator: (none)
• Enrollment: 160
• Location: 1

Study Details

Study Description

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	N/A

Study Design

• Study Type: Interventional
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: Double
• Primary Purpose: Prevention
• Study Completion Date: Aug 1, 2004

Outcome Measures

Primary Outcome Measures

1. Bleeding patterns []

Secondary Outcome Measures

1. Satisfaction, menstrual-associated symptoms []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 49 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00120913
• Other Study ID Numbers: OHSU IRB 7198
• First Posted: Jul 19, 2005
• Last Update Posted: Jul 19, 2005
• Last Verified: Jul 1, 2005

• Keywords provided by , ,: Breakthrough bleeding while taking continuously dosed oral contraceptives
• Additional relevant MeSH terms: Metrorrhagia; Hemorrhage; Contraceptives, Oral; Contraceptives, Oral, Combined

Study Results

No Results Posted as of Jul 19, 2005