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

• Evaluation of ovarian follicular development by the Hoogland and Skouby grading scale from baseline to week 16. [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
• Change in serum Estradiol level from baseline to week 16. [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
• Change in serum Follicle Stimulating Hormone (FSH) and Luteinizing Hormone (LH) levels from baseline to week 16. [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
• Change in serum Progesterone level from baseline to week 20. [ Time Frame: 20 weeks ] [ Designated as safety issue: No ]

• Change from baseline to week 15 in Prothrombin fragment 1 + 2 levels. [ Time Frame: 15 weeks ] [ Designated as safety issue: No ]
• Change from baseline to week 15 in D-dimer. [ Time Frame: 15 weeks ] [ Designated as safety issue: No ]
• Change from baseline to end of week 15 in Plasmin-Antiplasmin complex [ Time Frame: 15 weeks ] [ Designated as safety issue: No ]
• Change from baseline to week 15 in APTT and ETP based activated protein-C resistance (APC). [ Time Frame: 15 weeks ] [ Designated as safety issue: No ]
• Change from baseline to week 15 in Fibrinogen. [ Time Frame: 15 weeks ] [ Designated as safety issue: No ]
• Change from baseline to week 15 in Plasminogen, Factor II, Factor VII, Factor VIII, Protein C, and Free and Total Protein S. [ Time Frame: 15 weeks ] [ Designated as safety issue: No ]
• Change from baseline to week 15 in Tissue Plasminogen Activator (t-PA). [ Time Frame: 15 weeks ] [ Designated as safety issue: No ]
• Change from baseline to week 15 in Antithrombin. [ Time Frame: 15 weeks ] [ Designated as safety issue: No ]
• Change from baseline to week 15 in Tissue Factor Pathway Inhibitor (TFPI). [ Time Frame: 15 weeks ] [ Designated as safety issue: No ]
• Change from baseline to week 15 in Total Cortisol and Corticosteroid Binding Globulin (CBG). [ Time Frame: 15 weeks ] [ Designated as safety issue: No ]
• Change from baseline to week 15 in Thyroid Stimulating Hormone (TSH). [ Time Frame: 15 weeks ] [ Designated as safety issue: No ]
• Change from baseline to week 15 in Sex Hormone Binding Globulin (SHBG). [ Time Frame: 15 weeks ] [ Designated as safety issue: No ]
• Return to ovulation rate at week 20. [ Time Frame: Week 20 ] [ Designated as safety issue: No ]

• Change from baseline to week 15 in Prothrombin fragment 1 + 2 levels. [ Time Frame: 15 weeks ] [ Designated as safety issue: No ]
• Change from baseline to week 15 in D-dimer. [ Time Frame: 15 weeks ] [ Designated as safety issue: No ]
• Change from baseline to end of week 15 in Plamin-Antiplasmin complex [ Time Frame: 15 weeks ] [ Designated as safety issue: No ]
• Change from baseline to week 15 in APTT and ETP based activated protein-C resistance (APC). [ Time Frame: 15 weeks ] [ Designated as safety issue: No ]
• Change from baseline to week 15 in Fibrinogen. [ Time Frame: 15 weeks ] [ Designated as safety issue: No ]
• Change from baseline to week 15 in Plasminogen, Factor II, Factor VII, Factor VIII, Protein C, and Free and Total Protein S. [ Time Frame: 15 weeks ] [ Designated as safety issue: No ]
• Change from baseline to week 15 in Tissue Plasminogen Activator (t-PA). [ Time Frame: 15 weeks ] [ Designated as safety issue: No ]
• Change from baseline to week 15 in Antithrombin. [ Time Frame: 15 weeks ] [ Designated as safety issue: No ]
• Change from baseline to week 15 in Tissue Factor Pathway Inhibitor (TFPI). [ Time Frame: 15 weeks ] [ Designated as safety issue: No ]
• Change from baseline to week 15 in Total Cortisol and Corticosteroid Binding Globulin (CBG). [ Time Frame: 15 weeks ] [ Designated as safety issue: No ]
• Change from baseline to week 15 in Thyroid Stimulating Hormone (TSH). [ Time Frame: 15 weeks ] [ Designated as safety issue: No ]
• Change from baseline to week 15 in Sex Hormone Binding Globulin (SHBG). [ Time Frame: 15 weeks ] [ Designated as safety issue: No ]
• Return to ovulation rate at week 20. [ Time Frame: Week 20 ] [ Designated as safety issue: No ]

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.

• Follicle Development
• Ovarian Follicle
• Follicle Count
• Follicle Size
• Oral Contraceptive

• Drug: Desogestrel/ethinyl estradiol and ethinyl estradiol
  Desogestrel/ethinyl estradiol 0.15/0.02 mg and ethinyl estradiol 0.01 mg tablet
• Drug: 28-day drospirenone oral contraceptive
  Drospirenone/ethinyl estradiol 0.3/0.02 mg
• Drug: 28-day levonorgestrel oral contraceptive
  Levonorgestrel/ethinyl estradiol 0.1/0.02 mg

• Experimental: 28-day Desogestrel Oral Contraceptive
  Intervention: Drug: Desogestrel/ethinyl estradiol and ethinyl estradiol
• Active Comparator: 28-day Drospirenone Oral Contraceptive
  Intervention: Drug: 28-day drospirenone oral contraceptive
• Active Comparator: 28-day Levonorgestrel Oral Contraceptive
  Intervention: Drug: 28-day levonorgestrel oral contraceptive

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