Study of Bleeding With Extended Administration of an Oral Contraceptive

Warner Chilcott

Status and phase: Completed; Phase 2

Conditions: Contraception

Treatments: Drug: Norethindrone 1 mg / ethinyl estradiol 20 mcg

Study type: Interventional

Funder types: Industry

Identifiers

NCT00338052

PR-02306

Details and patient eligibility

About

This is an non-comparative study. There is no statistical hypothesis. The effects of extension of treatment on bleeding will be recorded and described.

Enrollment: 207 patients

Sex: Female

Ages: 25 to 40 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy women
• Age 25-40
• History of regular cycles

Exclusion criteria

• Current or recent (within 2 months) users of hormonal contraceptives
• Contraindications for use of hormonal contraception
• Conditions which affect the absorption or metabolism of steroid hormones
• BMI > 35

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)