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

Teva Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Healthy

Treatments: Drug: Mircette®; Drug: Kariva®; Drug: DR-1021

Study type: Interventional

Funder types: Industry

Identifiers

NCT00544882

DR-DSG-302

Details and patient eligibility

About

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

Full description

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.

Enrollment: 61 patients

Sex: Female

Ages: 18 to 35 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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61 participants in 2 patient groups

DR-1021

Experimental group

Description:

After randomization, participants received DR-1021 consisting of 150 μg desogestrel (DSG)/20 μg ethinyl estradiol (EE) administered orally as a combination tablet once daily for 21 days followed by EE 10 μg tablet once daily for 7 days (Cycle 2). Participants who completed Cycle 2 then received Kariva, consisting of 150 μg DSG/20 μg EE administered orally as a combination tablet taken once daily for 21 days followed by placebo tablet once daily for 2 days followed by 10 μg EE taken once daily for 5 days (Cycle 3).

Treatment:

Drug: DR-1021

Drug: Kariva®

Mircette

Active Comparator group

Description:

After randomization, participants received Mircette consisting of 150 μg desogestrel (DSG)/20 μg ethinyl estradiol (EE) administered orally as a combination tablet once daily for 21 days followed by placebo tablet once daily for 2 days followed by 10 μg EE tablet once daily for 5 days (Cycle 2). Participants who completed Cycle 2 then received Kariva, consisting of 150 μg DSG/20 μg EE administered orally as a combination tablet taken once daily for 21 days followed by placebo tablet once daily for 2 days followed by 10 μg EE taken once daily for 5 days (Cycle 3).

Treatment:

Drug: Kariva®

Drug: Mircette®