Text Size

Study of Safety and Efficacy of an Oral Contraceptive

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Warner Chilcott
ClinicalTrials.gov Identifier:
NCT00932321
First received: June 30, 2009
Last updated: April 15, 2013
Last verified: April 2013
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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:

U.S. FDA Resources

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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years to 45 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00932321

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

No publications provided

Responsible Party: Warner Chilcott
ClinicalTrials.gov Identifier: NCT00932321     History of Changes
Other Study ID Numbers: PR-03903
Study First Received: June 30, 2009
Results First Received: February 22, 2011
Last Updated: April 15, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Warner Chilcott:
Contraception

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

ClinicalTrials.gov processed this record on May 19, 2013