Open-Label Study of the Safety and Efficacy of a Low Dose Oral Contraceptive Containing Norethindrone Acetate and Ethinyl Estradiol

Warner Chilcott1 site in 1 country1,683 target enrollmentNovember 2006

ConditionsContraception

InterventionsNorethindrone acetate/ethinyl estradiol

DrugsNorethindrone acetate/ethinyl estradiol

Overview

Phase: Phase 3
Intervention: Norethindrone acetate/ethinyl estradiol
Conditions: Contraception
Sponsor: Warner Chilcott
Enrollment: 1683
Locations: 1
Primary Endpoint: Pregnancy Rate (Expressed as Pearl Index) in Women Aged 18 to 35, MITT Population,
Status: Completed
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

November 2006

End Date

September 2008

Last Updated

13 years ago

Study Type

Interventional

Study Design

Single Group

Sex

Female

Investigators

Sponsor

Warner Chilcott

Responsible Party

Sponsor

Eligibility Criteria

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

Arms & Interventions

study drug

Norethindrone/Ethinyl Estradiol

Intervention: Norethindrone acetate/ethinyl estradiol

Outcomes

Primary Outcomes

Pregnancy Rate (Expressed as Pearl Index) in Women Aged 18 to 35, MITT Population,

Time Frame: 13 cycles, 28 days each (1 year)

Pregnancy Rate (Expressed as Pearl Index) in Women Aged 18-45, MITT Population

Time Frame: 13 Cycles, 28 days each (1 year)

Secondary Outcomes

Number of Intracyclic Bleeding (IB)/Spotting Days Cycle 6, MITT Population(6 cycles, 28 days each (168 days))
Number of Intracyclic Bleeding (IB)/Spotting Days Cycle 13, MITT Population(13 cycles, 28 days each (1 year))
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))
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))