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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:
NCT00477633
First received: May 22, 2007
Last updated: April 15, 2013
Last verified: April 2013
History of Changes
  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/ethinyl estradiol
 Phase 3

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: An Open Label Study of the Contraceptive Efficacy of Norethindrone and Ethinyl Estradiol.

Resource links provided by NLM:

MedlinePlus related topics: Birth Control
U.S. FDA Resources

Further study details as provided by Warner Chilcott:

Primary Outcome Measures:
  • Pearl Index, 18-35 Years, MITT Population [ Time Frame: 13 cycles (28 days each), approximately 364 days ] [ Designated as safety issue: No ]
    Pregnancy rate in women 18-35 years old, Pearl Index - number of pregnancies per 100 women-years of treatment


Secondary Outcome Measures:
  • Mean Number of Days of Intracyclic Bleeding & Spotting, Cycles 2-13, MITT Population [ Time Frame: 12 cycles (28 days each), approximately 336 days ] [ Designated as safety issue: No ]
  • Mean Median Duration (Days) of Intracyclic Bleeding & Spotting, Cycles 2-13, MITT Population [ Time Frame: 12 cycles (28 days each), approximately 336 days ] [ Designated as safety issue: No ]
    Each IB episode has a unique duration, with 0, 1, 2, 3 or more episodes per cycle. To obtain "mean median duration" of episodes during a cycle, take the median duration of all episodes in each cycle. If there are no episodes in the cycle, then median duration is undefined/missing for that cycle. 1 episode - median duration = duration of that episode, 2 episodes - median duration = average of 2 durations, more than 2 episodes, calculated in usual way for median of an ordered set of numbers. Once median determined for each cycle/subject, the mean & SD of those quantities calculated.


Enrollment: 1700
Study Start Date: June 2007
Study Completion Date: February 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Norethindrone/ethinyl estradiol
1 tablet per day
 Drug: Norethindrone/ethinyl estradiol
1 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: NCT00477633

  Show 63 Study Locations
Sponsors and Collaborators
Warner Chilcott
Investigators
Study Director: Herman Ellman Sponsor GmbH
  More Information

No publications provided

Responsible Party: Warner Chilcott
ClinicalTrials.gov Identifier: NCT00477633     History of Changes
Other Study ID Numbers: PR-00207
Study First Received: May 22, 2007
Results First Received: October 13, 2010
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