Study of Safety and Efficacy of an Oral Contraceptive

Phase 3

Completed

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

• Registration Number: NCT00391807
• 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: 2006-10-20
• Study First Submitted QC: 2006-10-20
• Study First Posted: 2006-10-24
• Study Start: 2006-11
• Primary Completion: 2008-08
• Study Completion: 2008-09
• Results First Submitted: 2010-11-23
• Results First Submitted QC: 2010-11-23
• Results First Posted: 2010-12-22
• Status Verified: 2013-04
• Last Update Submitted: 2013-04-15
• Last Update Posted: 2013-04-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 1683

Inclusion Criteria

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

Read More

Exclusion Criteria

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
study drug	Norethindrone acetate/ethinyl estradiol	Norethindrone/Ethinyl Estradiol

Primary Outcome Measures

Name	Time	Method
Pregnancy Rate (Expressed as Pearl Index) in Women Aged 18 to 35, MITT Population,	13 cycles, 28 days each (1 year)
Pregnancy Rate (Expressed as Pearl Index) in Women Aged 18-45, MITT Population	13 Cycles, 28 days each (1 year)

Secondary Outcome Measures

Name	Time	Method
Number of Intracyclic Bleeding (IB)/Spotting Days Cycle 6, MITT Population	6 cycles, 28 days each (168 days)	MITT Population
Number of Intracyclic Bleeding (IB)/Spotting Days Cycle 13, MITT Population	13 cycles, 28 days each (1 year)	MITT Population
Percentage of Subjects With Withdrawal Bleeding (%), Cycle 13, MITT Population	13 cycles, 28 days each (1 year)
Percentage of Subjects With Withdrawal Bleeding (%), Cycle 2, MITT Population	2 cycles, 28 days each (56 days)
Percentage of Subjects With Amenorrhea, Cycle 6, MITT Population	6 cycles, 28 days each (168 days)
Percentage of Subjects With Amenorrhea, Cycle 13, MITT Population	13 cycles, 28 days each (1 year)
Median Duration of Withdrawal Bleeding, Cycle 6, MITT Population	6 cycles, 28 days each (168 days)
Median Duration of Withdrawal Bleeding, Cycle 12, MITT Population	12 cycles, 28 days each (336 days)
Total Number of Bleeding Days Per Cycle, Cycle 6, MITT Population	6 cycles, 28 days each (168 days)
Percentage of Subjects With Amenorrhea, Cycle 2, MITT Population	2 cycles, 28 days each (56 days)
Number of Intracyclic Bleeding (IB)/Spotting Days Cycle 2, MITT Population	2 Cycles, 28 days each (56 days)	MITT Population
Median Duration of Withdrawal Bleeding, Cycle 2, MITT Population	2 cycles, 28 days each (56 days)
Total Number of Bleeding Days Per Cycle, Cycle 13, MITT Population	13 cycles, 28 days each (1 year)
Percentage of Subjects With Withdrawal Bleeding (%), Cycle 6, MITT Population	6 cycles, 28 days each (168 days)
Total Number of Bleeding Days Per Cycle, Cycle 2, MITT Population	2 cycles, 28 days each (56 days)

Trial Locations

Locations (1)

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