Study of Safety and Efficacy of an Oral Contraceptive

Phase 3

Completed

• Conditions: Contraception
• Interventions: Drug: Norethindrone/ethinyl estradiol

• Registration Number: NCT00477633
• Lead Sponsor: Warner Chilcott

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2007-05-22
• Study First Submitted QC: 2007-05-23
• Study First Posted: 2007-05-24
• Study Start: 2007-06
• Primary Completion: 2009-01
• Study Completion: 2009-02
• Results First Submitted: 2010-10-13
• Results First Submitted QC: 2010-12-22
• Results First Posted: 2011-01-24
• Status Verified: 2013-04
• Last Update Submitted: 2013-04-15
• Last Update Posted: 2013-04-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 1700

Inclusion Criteria

• Healthy Women
• Age 18-45
• At risk for pregnancy
• History of regular cycles

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Norethindrone/ethinyl estradiol	Norethindrone/ethinyl estradiol	1 tablet per day

Primary Outcome Measures

Name	Time	Method
Pearl Index, 18-35 Years, MITT Population	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 Outcome Measures

Name	Time	Method
Mean Number of Days of Intracyclic Bleeding & Spotting, Cycles 2-13, MITT Population	12 cycles (28 days each), approximately 336 days
Mean Median Duration (Days) of Intracyclic Bleeding & Spotting, Cycles 2-13, MITT Population	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.

Trial Locations

Locations (1)

Warner Chilcott Investigational Site; 🇺🇸 Virginia Beach, Virginia, United States