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

Sponsored by:	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

MedlinePlus related topics: Birth Control

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

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	Open-Label Study of the Safety and Efficacy of a Low Dose Oral Contraceptive Containing Norethindrone Acetate and Ethinyl Estradiol

Further study details as provided by Warner Chilcott:

Primary Outcome Measures:

Pregnancy rate among women 18 to 35 years old, expressed in terms of the [ Time Frame: 13 cycles ] [ Designated as safety issue: No ]
Pearl Index defined as the number of pregnancies per 100 women-years of treatment. [ Time Frame: 13 cycles ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Descriptive parameters of bleeding/spotting, safety and tolerability. [ Time Frame: 13 cycles ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	1600
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
study drug: Experimental 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 61 Study Locations

Sponsors and Collaborators

Warner Chilcott

Investigators

Study Director:

Herman Ellman, MD

Sponsor GmbH

More Information

Responsible Party:	Warner Chilcott ( Dr. Herman Ellman )
Study ID Numbers:	PR-05806
Study First Received:	October 20, 2006
Last Updated:	October 21, 2008
ClinicalTrials.gov Identifier:	NCT00391807
Health Authority:	United States: Food and Drug Administration

Keywords provided by Warner Chilcott:

Contraception

Study placed in the following topic categories:

Norethindrone
Estradiol 3-benzoate
Estradiol valerate
Ethinyl Estradiol

Estradiol 17 beta-cypionate
Polyestradiol phosphate
Estradiol
Norethindrone acetate

Additional relevant MeSH terms:

Estrogens
Contraceptive Agents
Therapeutic Uses
Contraceptives, Oral
Physiological Effects of Drugs
Contraceptive Agents, Female

Hormones, Hormone Substitutes, and Hormone Antagonists
Contraceptives, Oral, Synthetic
Reproductive Control Agents
Hormones
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009