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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

June 30, 2009
April 15, 2013
January 2004
November 2004   (final data collection date for primary outcome measure)
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
Pregnancy rate among women 18 to 35 years old, expressed in terms of the Pearl Index defined as the number of pregnancies per 100 women-years of treatment. [ Time Frame: 6 Cycles (5.5 months) ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00932321 on ClinicalTrials.gov Archive Site
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.
Descriptive parameters of bleeding/spotting, safety and tolerability. [ Time Frame: 6 Cycles (5.5 months) ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Study of Safety and Efficacy of an Oral Contraceptive
Open Label, Randomized, Comparator-Controlled Study of the Contraceptive Efficacy of Norethindrone Acetate (NA) and Ethinyl Estradiol (EE)

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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Prevention of Pregnancy
  • Drug: Norethindrone Acetate/Ethinyl Estradiol 24 Days
    One tablet per day for 24 days of each 28 day cycle followed by 4 placebo tablets
  • 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
  • Experimental: 24 Day NA/EE
    Norethindrone acetate 1 mg /ethinyl estradiol 20 mcg for 24 days of each 28 day cycle
    Intervention: Drug: Norethindrone Acetate/Ethinyl Estradiol 24 Days
  • Active Comparator: 21 Day NA/EE
    Norethindrone acetate 1 mg/ethinyl estradiol 20 mcg for 21 days of each 28 day cycle
    Intervention: Drug: Norethindrone Acetate /Ethinyl Estradiol 21 Days
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
938
November 2004
November 2004   (final data collection date for primary outcome measure)

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
Female
18 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00932321
PR-03903
No
Warner Chilcott
Warner Chilcott
Not Provided
Study Director: Herman Ellman, MD Sponsor GmbH
Warner Chilcott
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP