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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: DR-1021; Drug: Kariva®; Drug: Mircette®

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.

• Study Type: Interventional
• Enrollment (Actual): 61
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Lawrenceville, New Jersey, United States, 08648
      • Duramed Investigational Site
  • Ohio
    • Columbus, Ohio, United States, 43213
      • Duramed Investigational Site
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19114
      • Duramed Investigational Site
  • Washington
    • Seattle, Washington, United States, 98105
      • Duramed Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 31 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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).	Drug: DR-1021; Twenty-one 150 μg desogestrel/20 μg ethinyl estradiol (EE) combination tablets plus seven 10 μg EE tablets.; Other Names: desogestrel/ethinyl estradiol; Drug: Kariva®; Twenty-one 150 μg desogestrel/20 μg ethinyl estradiol (EE) combination tablets plus two placebo tablets plus five 10 μg EE tablets.; Other Names: desogestrel/ethinyl estradiol
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).	Drug: Kariva®; Twenty-one 150 μg desogestrel/20 μg ethinyl estradiol (EE) combination tablets plus two placebo tablets plus five 10 μg EE tablets.; Other Names: desogestrel/ethinyl estradiol; Drug: Mircette®; Twenty-one 150 μg desogestrel/20 μg ethinyl estradiol (EE) combination tablets plus two placebo tablets plus five 10 μg EE tablets.; Other Names: desogestrel/ethinyl estradiol

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Follicles Greater Than 5 mm in Diameter	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).	Cycle 1, Days 11, 19-20, 23, 25, 27, Cycle 2, Days 4, 11, 19-20, 23, 25, 27, Cycle 3, Day 4.
Change From Cycle 2 Days 1 - 20 to Cycle 2 Days 21 - 28 in Maximum Follicle Size	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.	Cycle 2, Days 1-20 and Cycle 2, Days 21-28
Number of Days of Bleeding or Spotting During Unscheduled and Scheduled Study Periods	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.	Cycle 2, Days 1-21, Cycle 2, Days 22-28 and Cycle 3, Days 1-21
Percentage of Participants With Bleeding or Spotting During Unscheduled and Scheduled Study Periods	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.	Cycle 2, Days 1-21, Cycle 2, Days 22-28 and Cycle 3, Days 1-21
Number of Days of Bleeding During Unscheduled and Scheduled Study Periods	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.	Cycle 2, Days 1-21, Cycle 2, Days 22-28 and Cycle 3, Days 1-21
Percentage of Participants With Bleeding During Unscheduled and Scheduled Study Periods	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.	Cycle 2, Days 1-21, Cycle 2, Days 22-28 and Cycle 3, Days 1-21

Collaborators and Investigators

• Sponsor: Teva Branded Pharmaceutical Products R&D, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): October 31, 2007
• Primary Completion (Actual): March 31, 2008
• Study Completion (Actual): March 31, 2008

Study Registration Dates

• First Submitted: October 12, 2007
• First Submitted That Met QC Criteria: October 12, 2007
• First Posted (Estimate): October 16, 2007

Study Record Updates

• Last Update Posted (Actual): November 18, 2021
• Last Update Submitted That Met QC Criteria: November 16, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Estrogens; Contraceptive Agents, Hormonal; Contraceptive Agents; Reproductive Control Agents; Contraceptives, Oral, Combined; Contraceptives, Oral; Contraceptive Agents, Female; Contraceptives, Oral, Synthetic; Contraceptives, Oral, Hormonal; Progestins; Estradiol; Ethinyl Estradiol; Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Polyestradiol phosphate; Desogestrel; Oviol
• Other Study ID Numbers: DR-DSG-302