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OpenTrials
Completed

NCT Number: NCT00338052

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

Loading trial locations.

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

  1. Number of bleeding/spotting days/episodes per treatment cycle

Secondary outcomes

  1. Satisfaction

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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.

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