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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01140217
Recruitment Status : Completed
First Posted : June 9, 2010
Last Update Posted : September 19, 2013
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Contraceptive Usage Drug: Norethindrone Acetate Phase 3

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

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1659 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: An Open Label Study to Evaluate the Contraceptive Efficacy and Safety of Norethindrone Acetate Transdermal Delivery System
Study Start Date : May 2010
Primary Completion Date : March 2012
Study Completion Date : March 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Birth Control
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Active treatment
Norethindrone Acetate Transdermal Delivery System
Drug: Norethindrone Acetate
Norethindrone Acetate Transdermal Delivery System
Other Name: NEA TDS


Outcome Measures

Primary Outcome Measures :
  1. 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.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01140217


  Show 53 Study Locations
Sponsors and Collaborators
Watson Pharmaceuticals
Investigators
Study Director: Kim E Caramelli, MS Watson Pharmaceuticals, Inc.
More Information

Responsible Party: Watson Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01140217     History of Changes
Other Study ID Numbers: NE0906
First Posted: June 9, 2010    Key Record Dates
Last Update Posted: September 19, 2013
Last Verified: September 2013

Keywords provided by Watson Pharmaceuticals:
contraception
pregnancy

Additional relevant MeSH terms:
Norethindrone
Norethindrone acetate
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs