We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Study of Safety and Efficacy of an Oral Contraceptive

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00932321
First Posted: July 3, 2009
Last Update Posted: April 22, 2013
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.
Information provided by (Responsible Party):
Warner Chilcott
  Purpose
This is a comparative study. The primary objective of the study is to assess the efficacy of a low dose oral contraceptive in the prevention of pregnancy. The secondary objectives are to assess the incidence of intracyclic bleeding of norethindrone acetate/ethinyl estradiol (NETA/EE) administered for 24 days and NETA/EE administered for 21 days; and to assess the safety and tolerability of the product.

Condition Intervention Phase
Prevention of Pregnancy Drug: Norethindrone Acetate/Ethinyl Estradiol 24 Days Drug: Norethindrone Acetate /Ethinyl Estradiol 21 Days Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Open Label, Randomized, Comparator-Controlled Study of the Contraceptive Efficacy of Norethindrone Acetate (NA) and Ethinyl Estradiol (EE)

Resource links provided by NLM:


Further study details as provided by Warner Chilcott:

Primary Outcome Measures:
  • Pregnancy Rate (Expressed as Pearl Index) for Women 18 to 45 Years Old, MITT Population [ Time Frame: 5.6 months (6 - 28 day cycles) ]
    Pearl Index = 1300 * number of pregnancies/number of women-cycles of treatment


Secondary Outcome Measures:
  • Mean Number of Intracyclic Bleeding (IB)/Spotting Days in Cycles 2-6, MITT Population [ Time Frame: 5.6 months (6 - 28 day cycles) ]
    Self-reported via patient completed diary (none - no vaginal bleeding, light - less than normal menstruation, normal - like normal menstruation, heavy - more than normal menstruation) along with daily use of sanitary protection (other than panty liners). Light bleeding requiring no more than single pad or tampon will be spotting.


Enrollment: 938
Study Start Date: January 2004
Study Completion Date: November 2004
Primary Completion Date: November 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 24 Day NA/EE
Norethindrone acetate 1 mg /ethinyl estradiol 20 mcg for 24 days of each 28 day cycle
Drug: Norethindrone Acetate/Ethinyl Estradiol 24 Days
One tablet per day for 24 days of each 28 day cycle followed by 4 placebo tablets
Active Comparator: 21 Day NA/EE
Norethindrone acetate 1 mg/ethinyl estradiol 20 mcg for 21 days of each 28 day cycle
Drug: Norethindrone Acetate /Ethinyl Estradiol 21 Days
One tablet per day for 21 days of each 28 day cycle followed by 7 placebo tablets
Other Name: 21 Day NA/EE

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

Inclusion Criteria:

  • Healthy Women
  • Age 18-45
  • At risk for pregnancy
  • History of regular cycles

Exclusion Criteria:

  • Contraindications for use of hormonal contraception
  • Conditions which affect the absorption or metabolism of steroid hormones
  • BMI > 35
  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): NCT00932321


  Show 34 Study Locations
Sponsors and Collaborators
Warner Chilcott
Investigators
Study Director: Herman Ellman, MD Sponsor GmbH
  More Information

Responsible Party: Warner Chilcott
ClinicalTrials.gov Identifier: NCT00932321     History of Changes
Other Study ID Numbers: PR-03903
First Submitted: June 30, 2009
First Posted: July 3, 2009
Results First Submitted: February 22, 2011
Results First Posted: March 22, 2011
Last Update Posted: April 22, 2013
Last Verified: April 2013

Keywords provided by Warner Chilcott:
Contraception

Additional relevant MeSH terms:
Estradiol
Polyestradiol phosphate
Ethinyl Estradiol
Estradiol 3-benzoate
Estradiol 17 beta-cypionate
Estradiol valerate
Contraceptive Agents
Norethindrone
Norethindrone acetate
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Reproductive Control Agents
Contraceptive Agents, Female
Contraceptives, Oral, Synthetic
Contraceptives, Oral