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

Phase 3

Completed

Conditions: Healthy

Interventions: Drug: DR-1021
Drug: Mircette®
Drug: Kariva®

Registration Number: NCT00544882

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

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 61

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 & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DR-1021	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).
Mircette	Kariva®	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).
DR-1021	Kariva®	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).
Mircette	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).

Primary Outcome Measures

Name	Time	Method
Serum Estradiol Levels by Cycle Day	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	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	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 Outcome Measures

Name	Time	Method
Percentage of Follicles Greater Than 5 mm in Diameter	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	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 During Unscheduled and Scheduled Study Periods	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.
Number of Days of Bleeding or Spotting During Unscheduled and Scheduled Study Periods	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	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.
Percentage of Participants With Bleeding During Unscheduled and Scheduled Study Periods	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.