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

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

Detailed Description
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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.

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

Conditions
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Healthy

Intervention / Treatment
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* Drug: DR-1021
* Drug: Mircette®
* Drug: Kariva®


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DR-1021<br>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<br>* Twenty-one 150 μg desogestrel/20 μg ethinyl estradiol (EE) combination tablets plus seven 10 μg EE tablets.<br>* Other names: desogestrel/ethinyl estradiol;Drug: Kariva®<br>* Twenty-one 150 μg desogestrel/20 μg ethinyl estradiol (EE) combination tablets plus two placebo tablets plus five 10 μg EE tablets.<br>* Other names: desogestrel/ethinyl estradiol;|
| Active Comparator: Mircette<br>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: Mircette®<br>* Twenty-one 150 μg desogestrel/20 μg ethinyl estradiol (EE) combination tablets plus two placebo tablets plus five 10 μg EE tablets.<br>* Other names: desogestrel/ethinyl estradiol;Drug: Kariva®<br>* Twenty-one 150 μg desogestrel/20 μg ethinyl estradiol (EE) combination tablets plus two placebo tablets plus five 10 μg EE tablets.<br>* Other names: desogestrel/ethinyl estradiol;|

What is the study measuring?
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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 |