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Study of Safety and Efficacy of an Oral Contraceptive

NCT00932321 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 938

Last updated 2013-04-22

Study results available
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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.

Conditions

  • Prevention of Pregnancy

Interventions

DRUG

Norethindrone Acetate/Ethinyl Estradiol 24 Days

One tablet per day for 24 days of each 28 day cycle followed by 4 placebo tablets

DRUG

Norethindrone Acetate /Ethinyl Estradiol 21 Days

One tablet per day for 21 days of each 28 day cycle followed by 7 placebo tablets

Sponsors & Collaborators

  • Warner Chilcott

    lead INDUSTRY

Principal Investigators

  • Herman Ellman, MD · Sponsor GmbH

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2004-01-31
Primary Completion
2004-11-30
Completion
2004-11-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00932321 on ClinicalTrials.gov