A Study to Evaluate Hormone Patterns and Ovarian Follicular Activity With DR-1021

A Prospective, Multicenter, Randomized, Double-Blind Study to Evaluate Hormone Patterns and Ovarian Follicular Activity With the Oral Contraceptive Regimen DR-1021

This is a multi-center study to evaluate hormone levels with the oral contraceptive regimen DR-1021.

Female volunteers, aged 18-35 years old who met all Inclusion and no Exclusion Criteria, were enrolled in this study. All participants were current users of a standard 21/7 oral contraceptive regimen (21 days of combination progestin/estrogen followed by 7 days placebo) and had completed at least one 28-day cycle prior to beginning the Cycle 1 baseline cycle. After completing screening, all enrolled participants continued to receive the same regimen of 150 μg DSG /20 μg EE combination pills once daily for 21 days followed by placebo once daily for 7 days during Cycle 1 (the Run-In phase). Following completion of Cycle 1, participants were randomly assigned to receive either DR-1021 or Mircette during Cycle 2. All participants who completed Cycle 2 were to receive Kariva during Cycle 3; however, participants were only followed for the first 21 days of this 28-day regimen, after which they were considered study completers.

Inclusion Criteria:

• Premenopausal
• Weight <200 lbs
• Currently taking or willing to be treated with an oral contraceptive with a standard 21/7 regimen for one cycle prior to starting Study Cycle 1
• Others as dictated by protocol

Exclusion Criteria:

• Any contraindication to the use of oral contraceptives
• Breast feeding
• Smoking > 10 cigarettes per day
• Use of drugs that require simultaneous use of contraceptives (e.g., isotretinoin [Accutane])
• Others as dictated by protocol