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

Overview

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

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: March 2008

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.

Interventions

  • Drug: DR-1021
    • Twenty-one 150 μg desogestrel/20 μg ethinyl estradiol (EE) combination tablets plus seven 10 μg EE tablets.
  • Drug: Mircette®
    • Twenty-one 150 μg desogestrel/20 μg ethinyl estradiol (EE) combination tablets plus two placebo tablets plus five 10 μg EE tablets.
  • Drug: Kariva®
    • Twenty-one 150 μg desogestrel/20 μg ethinyl estradiol (EE) combination tablets plus two placebo tablets plus five 10 μg EE tablets.

Arms, Groups and Cohorts

  • Experimental: 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).
  • Active Comparator: 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).

Clinical Trial Outcome Measures

Primary Measures

  • Serum Estradiol Levels by Cycle Day
    • Time Frame: Cycle 2, Day 2 (Baseline), and Days 4, 6, 19-20, 23, 24, 25, 27, 28, Cycle 3, Days 2, 4 and 6.
    • Levels of estradiol were measured throughout the study from blood samples.
  • Serum Follicle Stimulating Hormone (FSH) Levels by Cycle Day
    • Time Frame: Cycle 2, Day 2 (Baseline), and Days 4, 6, 19-20, 23, 24, 25, 27, 28, Cycle 3, Days 2, 4 and 6.
    • Levels of follicle stimulating hormone were measured throughout the study from blood samples.
  • Serum Inhibin-B Levels by Cycle Day
    • Time Frame: Cycle 2, Day 2 (Baseline), and Days 4, 6, 19-20, 23, 24, 25, 27, 28, Cycle 3, Days 2, 4 and 6.
    • Levels of inhibin-B were measured throughout the study from blood samples.

Secondary Measures

  • Percentage of Follicles Greater Than 5 mm in Diameter
    • Time Frame: Cycle 1, Days 11, 19-20, 23, 25, 27, Cycle 2, Days 4, 11, 19-20, 23, 25, 27, Cycle 3, Day 4.
    • Ovarian follicles were measured by trans-vaginal ultrasound. The size of the 3 largest follicles was documented for each participant, and the percentage of follicles greater than 5 mm in diameter was calculated based on the total number follicles present (indicated by n for each time point).
  • Change From Cycle 2 Days 1 – 20 to Cycle 2 Days 21 – 28 in Maximum Follicle Size
    • Time Frame: Cycle 2, Days 1-20 and Cycle 2, Days 21-28
    • The change in the size of the largest documented follicle during combination therapy (Days 1 to 21) and during monotherapy/placebo (Days 21-28) measured by trans-vaginal ultrasound.
  • Number of Days of Bleeding or Spotting During Unscheduled and Scheduled Study Periods
    • Time Frame: Cycle 2, Days 1-21, Cycle 2, Days 22-28 and Cycle 3, Days 1-21
    • The total number of days of unscheduled (Day 1 to Day 21 of each cycle) and scheduled (ie,withdrawal [Day 22 to Day 28 of each cycle]) bleeding or spotting was derived from participant diaries.
  • Percentage of Participants With Bleeding or Spotting During Unscheduled and Scheduled Study Periods
    • Time Frame: Cycle 2, Days 1-21, Cycle 2, Days 22-28 and Cycle 3, Days 1-21
    • The percentage of participants with unscheduled (Day 1 to Day 21 of each cycle) and scheduled (ie,withdrawal [Day 22 to Day 28 of each cycle]) bleeding or spotting was derived from participant diaries.
  • Number of Days of Bleeding During Unscheduled and Scheduled Study Periods
    • Time Frame: Cycle 2, Days 1-21, Cycle 2, Days 22-28 and Cycle 3, Days 1-21
    • The total number of days of unscheduled (Day 1 to Day 21 of each cycle) and scheduled (ie,withdrawal [Day 22 to Day 28 of each cycle]) bleeding (not including spotting) was derived from participant diaries.
  • Percentage of Participants With Bleeding During Unscheduled and Scheduled Study Periods
    • Time Frame: Cycle 2, Days 1-21, Cycle 2, Days 22-28 and Cycle 3, Days 1-21
    • The percentage of participants with unscheduled (Day 1 to Day 21 of each cycle) and scheduled (ie,withdrawal [Day 22 to Day 28 of each cycle]) bleeding (not including spotting) was derived from participant diaries.

Participating in This Clinical Trial

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

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: 35 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Teva Branded Pharmaceutical Products R&D, Inc.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Duramed Protocol Chair, Study Chair, Duramed Research, Inc.

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.