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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01140217

Acronym

Simplify

Enrollment

1659

Registered

2010-06-09

Start date

2010-05-31

Completion date

2012-03-31

Last updated

2013-09-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Contraceptive Usage

Keywords

contraception, pregnancy

Brief summary

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.

Detailed description

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

Interventions

DRUGNorethindrone Acetate

Norethindrone Acetate Transdermal Delivery System

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 45 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Pregnancy Rate	1 year	The pregnancy rate will be calculated using the Pearl Index that defined as 1300\*Number of pregnancies/Number of cycles of treatment.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026