A Study to Evaluate Ovarian Follicular Activity and Hormone Levels for DR-102 Compared to Two 28-Day Oral Contraceptives

Study Overview
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Brief Summary
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This study is being conducted to evaluate the impact of a 28-day oral contraceptive compared to two 28-day oral contraceptive regimens containing different synthetic progestins on ovarian follicular activity and hormone levels in healthy women.

Official Title
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A Multicenter, Open-Label Study to Evaluate Ovarian Follicular Activity and Hormone Levels With the Oral Contraceptive Regimen DR-102 Compared to Two 28-day Oral Contraceptive Regimens Containing Different Synthetic Progestins

Conditions
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Ovarian Follicle, Follicle Count, Follicle Size, Oral Contraceptive, Follicle Development

Intervention / Treatment
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* Drug: Desogestrel/ethinyl estradiol and ethinyl estradiol
* Drug: 28-day drospirenone oral contraceptive
* Drug: 28-day levonorgestrel oral contraceptive


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Premenopausal, non-pregnant, non-lactating women age 18-35 years old Body Mass Index (BMI) ≥18 kg/m² and <30 kg/m² Regular spontaneous menstrual cycle Others as dictated by Food and Drug Administration (FDA)-approved protocol Exclusion Criteria: Any condition which contraindicates the use of combination oral contraceptives Known thrombophlebitis or thromboembolic disorders; known or suspected clotting disorders; thrombogenic valvulopathies or rhythm disorders Migraine headaches with focal, neurological symptoms Others as dictated by FDA-approved 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: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 28-day Desogestrel Oral Contraceptive<br> | Drug: Desogestrel/ethinyl estradiol and ethinyl estradiol<br>* Desogestrel/ethinyl estradiol 0.15/0.02 mg and ethinyl estradiol 0.01 mg tablet<br>|
| Active Comparator: 28-day Drospirenone Oral Contraceptive<br> | Drug: 28-day drospirenone oral contraceptive<br>* Drospirenone/ethinyl estradiol 0.3/0.02 mg<br>|
| Active Comparator: 28-day Levonorgestrel Oral Contraceptive<br> | Drug: 28-day levonorgestrel oral contraceptive<br>* Levonorgestrel/ethinyl estradiol 0.1/0.02 mg<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of ovarian follicular development by the Hoogland and Skouby grading scale from baseline to week 16. |  | 16 weeks | 
| Change in serum Estradiol level from baseline to week 16. |  | 16 weeks | 
| Change in serum Follicle Stimulating Hormone (FSH) and Luteinizing Hormone (LH) levels from baseline to week 16. |  | 16 weeks | 
| Change in serum Progesterone level from baseline to week 20. |  | 20 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline to week 15 in Prothrombin fragment 1 + 2 levels. |  | 15 weeks | 
| Change from baseline to week 15 in D-dimer. |  | 15 weeks | 
| Change from baseline to end of week 15 in Plasmin-Antiplasmin complex |  | 15 weeks | 
| Change from baseline to week 15 in APTT and ETP based activated protein-C resistance (APC). |  | 15 weeks | 
| Change from baseline to week 15 in Fibrinogen. |  | 15 weeks | 
| Change from baseline to week 15 in Plasminogen, Factor II, Factor VII, Factor VIII, Protein C, and Free and Total Protein S. |  | 15 weeks | 
| Change from baseline to week 15 in Tissue Plasminogen Activator (t-PA). |  | 15 weeks | 
| Change from baseline to week 15 in Antithrombin. |  | 15 weeks | 
| Change from baseline to week 15 in Tissue Factor Pathway Inhibitor (TFPI). |  | 15 weeks | 
| Change from baseline to week 15 in Total Cortisol and Corticosteroid Binding Globulin (CBG). |  | 15 weeks | 
| Change from baseline to week 15 in Thyroid Stimulating Hormone (TSH). |  | 15 weeks | 
| Change from baseline to week 15 in Sex Hormone Binding Globulin (SHBG). |  | 15 weeks | 
| Return to ovulation rate at week 20. |  | Week 20 |