Study of Bleeding With Extended Administration of an Oral Contraceptive

This is an non-comparative study. There is no statistical hypothesis. The effects of extension of treatment on bleeding will be recorded and described.

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Key information

Conditions

Contraception

Age range

25 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Warner Chilcott Investigational Site, Phoenix, Arizona, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

Healthy women
Age 25-40
History of regular cycles

Exclusion criteria

Current or recent (within 2 months) users of hormonal contraceptives
Contraindications for use of hormonal contraception
Conditions which affect the absorption or metabolism of steroid hormones
BMI > 35

Treatment and study plan

Norethindrone 1 mg / ethinyl estradiol 20 mcg

Drug

Primary outcomes

Number of bleeding/spotting days/episodes per treatment cycle

Secondary outcomes

Satisfaction

Sponsors and collaborators

Lead sponsor

Warner Chilcott

Industry

Registry information

Official study title

Open-Label Study of Cycle Control With Extended Administration of Norethindrone Acetate 1 mg / Ethinyl Estradiol 20 Mcg Oral Tablets

Important dates

Study start: 2006
Primary completion: 2007
Study completion: 2007
First posted: Jun 20, 2006
Registry last updated: May 8, 2008

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

View the official ClinicalTrials.gov record (opens in a new tab)

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.

Published trials that share one or more normalized conditions with this study.

Completed