Study of Safety and Efficacy of an Oral Contraceptive

Warner Chilcott1,683 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

1,683

Conditions

Contraception

Interventions

Norethindrone acetate/ethinyl estradiolDRUG

one tablet per day

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (66)

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 2, MITT Population

MITT Population

Time frame: 2 Cycles, 28 days each (56 days)

Number of Intracyclic Bleeding (IB)/Spotting Days Cycle 6, MITT Population

MITT Population

Time frame: 6 cycles, 28 days each (168 days)

Number of Intracyclic Bleeding (IB)/Spotting Days Cycle 13, MITT Population

MITT Population

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

Percentage of Subjects With Withdrawal Bleeding (%), Cycle 2, MITT Population

Time frame: 2 cycles, 28 days each (56 days)

Percentage of Subjects With Withdrawal Bleeding (%), Cycle 6, MITT Population

Time frame: 6 cycles, 28 days each (168 days)

Percentage of Subjects With Withdrawal Bleeding (%), Cycle 13, MITT Population

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

Median Duration of Withdrawal Bleeding, Cycle 2, MITT Population

Time frame: 2 cycles, 28 days each (56 days)

Data from ClinicalTrials.gov

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