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

NCT ID: NCT00544882

Last Updated: 2021-11-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 61 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-10-31
• Study Completion Date: 2008-03-31

Brief Summary

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

Detailed 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.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

DR-1021

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).

Group Type: EXPERIMENTAL

DR-1021

Intervention Type: DRUG

Twenty-one 150 μg desogestrel/20 μg ethinyl estradiol (EE) combination tablets plus seven 10 μg EE tablets.

Kariva®

Intervention Type: DRUG

Twenty-one 150 μg desogestrel/20 μg ethinyl estradiol (EE) combination tablets plus two placebo tablets plus five 10 μg EE tablets.

Mircette

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).

Group Type: ACTIVE_COMPARATOR

Mircette®

Intervention Type: DRUG

Twenty-one 150 μg desogestrel/20 μg ethinyl estradiol (EE) combination tablets plus two placebo tablets plus five 10 μg EE tablets.

Kariva®

Intervention Type: DRUG

Twenty-one 150 μg desogestrel/20 μg ethinyl estradiol (EE) combination tablets plus two placebo tablets plus five 10 μg EE tablets.

Interventions

DR-1021

Twenty-one 150 μg desogestrel/20 μg ethinyl estradiol (EE) combination tablets plus seven 10 μg EE tablets.

Intervention Type: DRUG

Mircette®

Twenty-one 150 μg desogestrel/20 μg ethinyl estradiol (EE) combination tablets plus two placebo tablets plus five 10 μg EE tablets.

Intervention Type: DRUG

Kariva®

Twenty-one 150 μg desogestrel/20 μg ethinyl estradiol (EE) combination tablets plus two placebo tablets plus five 10 μg EE tablets.

Intervention Type: DRUG

Other Intervention Names

desogestrel/ethinyl estradiol; desogestrel/ethinyl estradiol; desogestrel/ethinyl estradiol

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Teva Branded Pharmaceutical Products R&D, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Duramed Protocol Chair

Role: STUDY_CHAIR

Duramed Research, Inc.

Locations

Duramed Investigational Site

Lawrenceville, New Jersey, United States

Duramed Investigational Site

Columbus, Ohio, United States

Duramed Investigational Site

Philadelphia, Pennsylvania, United States

Duramed Investigational Site

Seattle, Washington, United States

Countries

United States

Other Identifiers

DR-DSG-302

Identifier Type: -

Identifier Source: org_study_id