NCT01140217

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,659

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started May 2010

Geographic Reach
1 country

53 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2010

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

May 18, 2010

Completed
22 days until next milestone

First Posted

Study publicly available on registry

June 9, 2010

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
Last Updated

September 19, 2013

Status Verified

September 1, 2013

Enrollment Period

1.8 years

First QC Date

May 18, 2010

Last Update Submit

September 13, 2013

Conditions

Contraceptive Usage

Keywords

contraceptionpregnancy

Outcome Measures

Primary Outcomes (1)

  • Pregnancy Rate

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

    1 year

Study Arms (1)

Active treatment

EXPERIMENTAL

Norethindrone Acetate Transdermal Delivery System

Drug: Norethindrone Acetate

Interventions

Norethindrone AcetateDRUG

Norethindrone Acetate Transdermal Delivery System

Also known as: NEA TDS
Active treatment

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (53)

Watson Investigational Site

Birmingham, Alabama, United States

Location

Watson Investigational Site

Mobile, Alabama, United States

Location

Watson Investigational Site

Montgomery, Alabama, United States

Location

Watson Investigational Site

Chandler, Arizona, United States

Location

Watson Investigational Site

Little Rock, Arkansas, United States

Location

Watson Investigational Site

Garden Grove, California, United States

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Watson Investigational Site

La Mesa, California, United States

Location

Watson Investigational Site

San Diego, California, United States

Location

Watson Investigational Site

Denver, Colorado, United States

Location

Watson Investigational Site

Newark, Delaware, United States

Location

Watson Investigational Site

Washington D.C., District of Columbia, United States

Location

Watson Investigational Site

Aventura, Florida, United States

Location

Watson Investigational Site

Daytona Beach, Florida, United States

Location

Watson Investigational Site

Jacksonville, Florida, United States

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Watson Investigational Site

Lake Worth, Florida, United States

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Watson Investigational Site

Miami, Florida, United States

Location

Watson Investigational Site

North Miami, Florida, United States

Location

Watson Investigational Site

Pinellas Park, Florida, United States

Location

Watson Investigational Site

Sarasota, Florida, United States

Location

Watson Investigational Site

Atlanta, Georgia, United States

Location

Watson Investigational Site

Decatur, Georgia, United States

Location

Watson Investigational Site

Sandy Springs, Georgia, United States

Location

Watson Investigational Site

Savannah, Georgia, United States

Location

Watson Investigational Site

Chicago, Illinois, United States

Location

Watson Investigational Site

Overland Park, Kansas, United States

Location

Watson Investigational Site

Marrero, Louisiana, United States

Location

Watson Investigational Site

New Orleans, Louisiana, United States

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Watson Investigational Site

Haverhill, Massachusetts, United States

Location

Watson Investigational Site

Ann Arbor, Michigan, United States

Location

Watson Investigational Site

Kalamazoo, Michigan, United States

Location

Watson Investigational Site

Edina, Minnesota, United States

Location

Watson Investigational Site

Las Vegas, Nevada, United States

Location

Watson Investigational Site

Lawrenceville, New Jersey, United States

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Watson Investigational Site

Albuquerque, New Mexico, United States

Location

Watson Investigational Site

New York, New York, United States

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Watson Investigational Site

Chapel Hill, North Carolina, United States

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Watson Investigational Site

New Bern, North Carolina, United States

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Watson Investigational Site

Raleigh, North Carolina, United States

Location

Watson Investigational Site

Cleveland, Ohio, United States

Location

Watson Investigational Site

Columbus, Ohio, United States

Location

Watson Investigational Site

Medford, Oregon, United States

Location

Watson Investigational Site

Philadelphia, Pennsylvania, United States

Location

Watson Investigational Site

Columbia, South Carolina, United States

Location

Watson Investigational Site

Greer, South Carolina, United States

Location

Watson Investigational Site

Hilton Head Island, South Carolina, United States

Location

Watson Investigational Site

Nashville, Tennessee, United States

Location

Watson Investigational Site

Austin, Texas, United States

Location

Watson Investigational Site

Dallas, Texas, United States

Location

Watson Investigational Site

Houston, Texas, United States

Location

Watson Investigational Site

San Antonio, Texas, United States

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Watson Investigational Site

Salt Lake City, Utah, United States

Location

Watson Investigational Site

Norfolk, Virginia, United States

Location

Watson Investigational Site

Seattle, Washington, United States

Location

MeSH Terms

Conditions

Contraception Behavior

Interventions

Norethindrone Acetate

Condition Hierarchy (Ancestors)

Reproductive BehaviorBehavior

Intervention Hierarchy (Ancestors)

NorethindroneNorpregnenesNorpregnanesNorsteroidsSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Kim E Caramelli, MS

    Watson Pharmaceuticals, Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 18, 2010

First Posted

June 9, 2010

Study Start

May 1, 2010

Primary Completion

March 1, 2012

Study Completion

March 1, 2012

Last Updated

September 19, 2013

Record last verified: 2013-09

Locations

US(53)