Efficacy and Safety Study of Norethindrone Acetate Transdermal Delivery System in Contraception

The purpose of this study is to determine whether NEA TDS is effective in the prevention of pregnancy. The safety of this product will also be evaluated.

Completed

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Key information

Conditions

Contraceptive Usage Behavior Contraception Behavior Reproductive Behavior

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Watson Investigational Site, Birmingham, Alabama, United States

About this study

An Open Label Study to Evaluate the Contraceptive Efficacy and Safety of Norethindrone Acetate Transdermal Delivery System.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Healthy females
18-45 years
Regular, consistent menstrual cycles between 25 and 35 days
Sexually active and at risk of becoming pregnant

Exclusion criteria

History of infertility
Known contraindications to progestogen administration
Pap smear suggestive of a high-grade precancerous lesion(s)
Clinically significant deviation from normal in any of the screening tests or exams

Treatment and study plan

Norethindrone acetate

Drug

Norethindrone Acetate Transdermal Delivery System

Other names: NEA TDS

Primary outcomes

Pregnancy Rate

Time frame: 1 year

The pregnancy rate will be calculated using the Pearl Index that defined as 1300*Number of pregnancies/Number of cycles of treatment.

Sponsors and collaborators

Lead sponsor

Watson Pharmaceuticals

Industry

Registry information

Official study title

An Open Label Study to Evaluate the Contraceptive Efficacy and Safety of Norethindrone Acetate Transdermal Delivery System

Acronym: Simplify

Important dates

Study start: 2010
Primary completion: 2012
Study completion: 2012
First posted: Jun 9, 2010
Registry last updated: Sep 19, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed