Study of Safety and Efficacy of an Oral Contraceptive

Phase 3

Completed

• Conditions: Prevention of Pregnancy
• Interventions: Drug: Norethindrone Acetate/Ethinyl Estradiol 24 Days; Drug: Norethindrone Acetate /Ethinyl Estradiol 21 Days

• Registration Number: NCT00932321
• Lead Sponsor: Warner Chilcott

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-01
• Primary Completion: 2004-11
• Study Completion: 2004-11
• Study First Submitted: 2009-06-30
• Study First Submitted QC: 2009-07-01
• Study First Posted: 2009-07-03
• Results First Submitted: 2011-02-22
• Results First Submitted QC: 2011-02-22
• Results First Posted: 2011-03-22
• Status Verified: 2013-04
• Last Update Submitted: 2013-04-15
• Last Update Posted: 2013-04-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 938

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: PARALLEL

Arm && Interventions

Group	Intervention	Description
24 Day NA/EE	Norethindrone Acetate/Ethinyl Estradiol 24 Days	Norethindrone acetate 1 mg /ethinyl estradiol 20 mcg for 24 days of each 28 day cycle
21 Day NA/EE	Norethindrone Acetate /Ethinyl Estradiol 21 Days	Norethindrone acetate 1 mg/ethinyl estradiol 20 mcg for 21 days of each 28 day cycle

Primary Outcome Measures

Name	Time	Method
Pregnancy Rate (Expressed as Pearl Index) for Women 18 to 45 Years Old, MITT Population	5.6 months (6 - 28 day cycles)	Pearl Index = 1300 \* number of pregnancies/number of women-cycles of treatment

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Warner Chilcott Investigational Site; 🇺🇸 Seattle, Washington, United States