Study of Safety and Efficacy of an Oral Contraceptive

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00477633
• Date of registration: 22/05/2007
• Primary sponsor: Warner Chilcott
• Public title: Study of Safety and Efficacy of an Oral Contraceptive
• Scientific title: An Open Label Study of the Contraceptive Efficacy of Norethindrone and Ethinyl Estradiol.
• Date of first enrolment: June 2007
• Target sample size: 1700
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00477633
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Countries of recruitment

United States

Contacts

• Name: Herman Ellman
• Affiliation: Sponsor GmbH

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 45 Years
Gender: Female

Health Condition(s) or Problem(s) studied

Contraception

Intervention(s)

Drug: Norethindrone/ethinyl estradiol

Primary Outcome(s)

Pearl Index, 18-35 Years, MITT Population [Time Frame: 13 cycles (28 days each), approximately 364 days]

Secondary Outcome(s)

Mean Median Duration (Days) of Intracyclic Bleeding & Spotting, Cycles 2-13, MITT Population [Time Frame: 12 cycles (28 days each), approximately 336 days]

Mean Number of Days of Intracyclic Bleeding & Spotting, Cycles 2-13, MITT Population [Time Frame: 12 cycles (28 days each), approximately 336 days]

Secondary ID(s)

PR-00207

Source(s) of Monetary Support

Please refer to primary and secondary sponsors