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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:
NCT00391807
First received: October 20, 2006
Last updated: April 15, 2013
Last verified: April 2013

October 20, 2006
April 15, 2013
November 2006
August 2008   (final data collection date for primary outcome measure)
  • Pregnancy Rate (Expressed as Pearl Index) in Women Aged 18 to 35, MITT Population, [ Time Frame: 13 cycles, 28 days each (1 year) ] [ Designated as safety issue: No ]
  • Pregnancy Rate (Expressed as Pearl Index) in Women Aged 18-45, MITT Population [ Time Frame: 13 Cycles, 28 days each (1 year) ] [ Designated as safety issue: No ]
  • 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.
Complete list of historical versions of study NCT00391807 on ClinicalTrials.gov Archive Site
  • Number of Intracyclic Bleeding (IB)/Spotting Days Cycle 2, MITT Population [ Time Frame: 2 Cycles, 28 days each (56 days) ] [ Designated as safety issue: Yes ]
    MITT Population
  • Number of Intracyclic Bleeding (IB)/Spotting Days Cycle 6, MITT Population [ Time Frame: 6 cycles, 28 days each (168 days) ] [ Designated as safety issue: Yes ]
    MITT Population
  • Number of Intracyclic Bleeding (IB)/Spotting Days Cycle 13, MITT Population [ Time Frame: 13 cycles, 28 days each (1 year) ] [ Designated as safety issue: Yes ]
    MITT Population
  • Percentage of Subjects With Withdrawal Bleeding (%), Cycle 2, MITT Population [ Time Frame: 2 cycles, 28 days each (56 days) ] [ Designated as safety issue: No ]
  • Percentage of Subjects With Withdrawal Bleeding (%), Cycle 6, MITT Population [ Time Frame: 6 cycles, 28 days each (168 days) ] [ Designated as safety issue: No ]
  • Percentage of Subjects With Withdrawal Bleeding (%), Cycle 13, MITT Population [ Time Frame: 13 cycles, 28 days each (1 year) ] [ Designated as safety issue: No ]
  • Median Duration of Withdrawal Bleeding, Cycle 2, MITT Population [ Time Frame: 2 cycles, 28 days each (56 days) ] [ Designated as safety issue: No ]
  • Median Duration of Withdrawal Bleeding, Cycle 6, MITT Population [ Time Frame: 6 cycles, 28 days each (168 days) ] [ Designated as safety issue: No ]
  • Median Duration of Withdrawal Bleeding, Cycle 12, MITT Population [ Time Frame: 12 cycles, 28 days each (336 days) ] [ Designated as safety issue: No ]
  • Total Number of Bleeding Days Per Cycle, Cycle 2, MITT Population [ Time Frame: 2 cycles, 28 days each (56 days) ] [ Designated as safety issue: No ]
  • Total Number of Bleeding Days Per Cycle, Cycle 6, MITT Population [ Time Frame: 6 cycles, 28 days each (168 days) ] [ Designated as safety issue: No ]
  • Total Number of Bleeding Days Per Cycle, Cycle 13, MITT Population [ Time Frame: 13 cycles, 28 days each (1 year) ] [ Designated as safety issue: No ]
  • Percentage of Subjects With Amenorrhea, Cycle 2, MITT Population [ Time Frame: 2 cycles, 28 days each (56 days) ] [ Designated as safety issue: No ]
  • Percentage of Subjects With Amenorrhea, Cycle 6, MITT Population [ Time Frame: 6 cycles, 28 days each (168 days) ] [ Designated as safety issue: No ]
  • Percentage of Subjects With Amenorrhea, Cycle 13, MITT Population [ Time Frame: 13 cycles, 28 days each (1 year) ] [ Designated as safety issue: No ]
Descriptive parameters of bleeding/spotting, safety and tolerability.
Not Provided
Not Provided
 
Study of Safety and Efficacy of an Oral Contraceptive
Open-Label Study of the Safety and Efficacy of a Low Dose Oral Contraceptive Containing Norethindrone Acetate and Ethinyl Estradiol

This is a non-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; and to assess the safety and tolerability of the product.

Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Contraception
Drug: Norethindrone acetate/ethinyl estradiol
one tablet per day
Experimental: study drug
Norethindrone/Ethinyl Estradiol
Intervention: Drug: Norethindrone acetate/ethinyl estradiol
Archer DF, Nakajima ST, Sawyer AT, Wentworth J, Trupin S, Koltun WD, Gilbert RD, Ellman H. Norethindrone acetate 1.0 milligram and ethinyl estradiol 10 micrograms as an ultra low-dose oral contraceptive. Obstet Gynecol. 2013 Sep;122(3):601-7. doi: 10.1097/AOG.0b013e3182a1741c.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1683
September 2008
August 2008   (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
 
NCT00391807
PR-05806
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