Study of Safety and Efficacy of an Oral Contraceptive - Full Text View

Sponsor:	Warner Chilcott
Information provided by:	Warner Chilcott
ClinicalTrials.gov Identifier:	NCT00391807

Purpose

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.

Condition	Intervention	Phase
Contraception	Drug: Norethindrone acetate/ethinyl estradiol	Phase III

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Prevention
Official Title:	Open-Label Study of the Safety and Efficacy of a Low Dose Oral Contraceptive Containing Norethindrone Acetate and Ethinyl Estradiol

Resource links provided by NLM:

MedlinePlus related topics: Birth Control

Drug Information available for: Estradiol Estradiol 3-benzoate Norethindrone acetate Ethinyl estradiol Norethindrone Polyestradiol phosphate Depogen Estradiol dipropionate Estradiol cypionate Estradiol valerate Estradiol acetate

U.S. FDA Resources

Further study details as provided by Warner Chilcott:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

Enrollment:	1683
Study Start Date:	November 2006
Study Completion Date:	September 2008
Primary Completion Date:	August 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: study drug Norethindrone/Ethinyl Estradiol	Drug: Norethindrone acetate/ethinyl estradiol one tablet per day

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: NCT00391807

Show 66 Study Locations

Sponsors and Collaborators

Warner Chilcott

Investigators

Study Director:

Herman Ellman, MD

Sponsor GmbH

More Information

No publications provided

Responsible Party:	Dr. Herman Ellman, Warner Chilcott
ClinicalTrials.gov Identifier:	NCT00391807 History of Changes
Other Study ID Numbers:	PR-05806
Study First Received:	October 20, 2006
Results First Received:	November 23, 2010
Last Updated:	February 14, 2011
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 acetate
Norethindrone
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 February 09, 2012