Study of Safety and Efficacy of an Oral Contraceptive

Warner Chilcott1,700 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

1,700

Conditions

Contraception

Interventions

Norethindrone/ethinyl estradiolDRUG

1 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 (63)

Outcomes

Primary Outcomes

Pearl Index, 18-35 Years, MITT Population

Pregnancy rate in women 18-35 years old, Pearl Index - number of pregnancies per 100 women-years of treatment

Time frame: 13 cycles (28 days each), approximately 364 days

Secondary Outcomes

Mean Number of Days of Intracyclic Bleeding & Spotting, Cycles 2-13, MITT Population

Time frame: 12 cycles (28 days each), approximately 336 days

Mean Median Duration (Days) of Intracyclic Bleeding & Spotting, Cycles 2-13, MITT Population

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.

Time frame: 12 cycles (28 days each), approximately 336 days

Data from ClinicalTrials.gov

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