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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Watson Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01140217
First received: May 18, 2010
Last updated: June 3, 2013
Last verified: June 2013
History of Changes
  Purpose

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 Intervention Phase
Contraceptive Usage
 Drug: Norethindrone Acetate
 Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: An Open Label Study to Evaluate the Contraceptive Efficacy and Safety of Norethindrone Acetate Transdermal Delivery System

Resource links provided by NLM:

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

Further study details as provided by Watson Pharmaceuticals:

Primary Outcome Measures:
  • Pregnancy Rate [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    The pregnancy rate will be calculated using the Pearl Index that defined as 1300*Number of pregnancies/Number of cycles of treatment.


Enrollment: 1659
Study Start Date: May 2010
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Active treatment
Norethindrone Acetate Transdermal Delivery System
 Drug: Norethindrone Acetate
Norethindrone Acetate Transdermal Delivery System
Other Name: NEA TDS

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01140217

  Show 46 Study Locations
Sponsors and Collaborators
Watson Pharmaceuticals
Investigators
Study Director: Kim E Caramelli, MS Watson Pharmaceuticals, Inc.
  More Information

No publications provided

Responsible Party: Watson Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01140217     History of Changes
Other Study ID Numbers: NE0906
Study First Received: May 18, 2010
Last Updated: June 3, 2013
Health Authority: United States: Food and Drug Administration

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
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on June 18, 2013