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Completed

NCT Number: NCT00932321

Study of Safety and Efficacy of an Oral Contraceptive

This is a comparative study. The primary objective of the study is to assess the efficacy of a low dose oral contraceptive in the prevention of pregnancy. The secondary objectives are to assess the incidence of intracyclic bleeding of norethindrone acetate/ethinyl estradiol (NETA/EE) administered for 24 days and NETA/EE administered for 21 days; and to assess the safety and tolerability of the product.

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Key information

Conditions

Prevention of Pregnancy

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Warner Chilcott Investigational Site, Birmingham, Alabama, 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 18-45
  • At risk for pregnancy
  • History of regular cycles

Exclusion criteria

  • Contraindications for use of hormonal contraception
  • Conditions which affect the absorption or metabolism of steroid hormones
  • BMI > 35

Treatment and study plan

Norethindrone Acetate/Ethinyl Estradiol 24 Days

Drug

One tablet per day for 24 days of each 28 day cycle followed by 4 placebo tablets

Norethindrone Acetate /Ethinyl Estradiol 21 Days

Drug

One tablet per day for 21 days of each 28 day cycle followed by 7 placebo tablets

Other names: 21 Day NA/EE

Primary outcomes

  1. Pregnancy Rate (Expressed as Pearl Index) for Women 18 to 45 Years Old, MITT Population

    Time frame: 5.6 months (6 - 28 day cycles)

    Pearl Index = 1300 * number of pregnancies/number of women-cycles of treatment

Secondary outcomes

  1. Mean Number of Intracyclic Bleeding (IB)/Spotting Days in Cycles 2-6, MITT Population

    Time frame: 5.6 months (6 - 28 day cycles)

    Self-reported via patient completed diary (none - no vaginal bleeding, light - less than normal menstruation, normal - like normal menstruation, heavy - more than normal menstruation) along with daily use of sanitary protection (other than panty liners). Light bleeding requiring no more than single pad or tampon will be spotting.

Sponsors and collaborators

Lead sponsor

Warner Chilcott

Industry

Registry information

Official study title

Open Label, Randomized, Comparator-Controlled Study of the Contraceptive Efficacy of Norethindrone Acetate (NA) and Ethinyl Estradiol (EE)

Important dates

Study start
2004
Primary completion
2004
Study completion
2004
First posted
Jul 3, 2009
Registry last updated
Apr 22, 2013

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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