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Completed

NCT Number: NCT00477633

Study of Safety and Efficacy of an Oral Contraceptive

This is a non-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; and to assess the safety and tolerability of the product.

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Key information

Conditions

Contraception

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Warner Chilcott Investigational Site, Chandler, 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 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/Ethinyl Estradiol

Drug

1 tablet per day

Primary outcomes

  1. Pearl Index, 18-35 Years, MITT Population

    Time frame: 13 cycles (28 days each), approximately 364 days

    Pregnancy rate in women 18-35 years old, Pearl Index - number of pregnancies per 100 women-years of treatment

Secondary outcomes

  1. Mean Number of Days of Intracyclic Bleeding & Spotting, Cycles 2-13, MITT Population

    Time frame: 12 cycles (28 days each), approximately 336 days

  2. Mean Median Duration (Days) of Intracyclic Bleeding & Spotting, Cycles 2-13, MITT Population

    Time frame: 12 cycles (28 days each), approximately 336 days

    Each IB episode has a unique duration, with 0, 1, 2, 3 or more episodes per cycle. To obtain "mean median duration" of episodes during a cycle, take the median duration of all episodes in each cycle. If there are no episodes in the cycle, then median duration is undefined/missing for that cycle. 1 episode - median duration = duration of that episode, 2 episodes - median duration = average of 2 durations, more than 2 episodes, calculated in usual way for median of an ordered set of numbers. Once median determined for each cycle/subject, the mean & SD of those quantities calculated.

Sponsors and collaborators

Lead sponsor

Warner Chilcott

Industry

Registry information

Official study title

An Open Label Study of the Contraceptive Efficacy of Norethindrone and Ethinyl Estradiol.

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
May 24, 2007
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.

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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