A Study to Evaluate Bleeding Patterns With Three Different Doses of DR-1031 Compared to Seasonale
Breakthrough Bleeding
About this trial
This is an interventional prevention trial for Breakthrough Bleeding focused on measuring oral contraceptives, breakthrough bleeding, spotting
Eligibility Criteria
Inclusion Criteria:
- Premenopausal
- Not pregnant or breastfeeding
- Agree to use back-up non-hormonal contraception for study period
Exclusion Criteria:
- Any contraindication to the use of oral contraceptives
- Pregnancy within the last 3 months
- Smoking >10 cigarettes per day
Sites / Locations
- Duramed Investigational Site
- Duramed Investigational Site
- Duramed Investigational Site
- Duramed Investigational Site
- Duramed Investigational Site
- Duramed Investigational Site
- Duramed Investigational Site
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- Duramed Investigational Site
- Duramed Investigational Site
- Duramed Investigational Site
- Duramed Investigational Site
- Duramed Investigational Site
- Duramed Investigational Site
- Duramed Investigational Site
- Duramed Investigational Site
- Duramed Investigational Site
- Duramed Investigational Site
- Duramed Investigational Site
- Duramed Investigational Site
- Duramed Investigational Site
- Duramed Investigational Site
- Duramed Investigational Site
- Duramed Investigational Site
- Duramed Investigational Site
- Duramed Investigational Site
- Duramed Investigational Site
- Duramed Investigational Site
- Duramed Investigational Site
- Duramed Investigational Site
- Duramed Investigational Site
- Duramed Investigational Site
- Duramed Investigational Site
- Duramed Investigational Site
- Duramed Investigational Site
- Duramed Investigational Site
- Duramed Investigational Site
- Duramed Investigational Site
- Duramed Investigational Site
- Duramed Investigational Site
- Duramed Investigational Site
- Duramed Investigational Site
- Duramed Investigational Site
- Duramed Investigational Site
- Duramed Investigational Site
- Duramed Investigational Site
- Duramed Investigational Site
- Duramed Investigational Site
- Duramed Investigational Site
- Duramed Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Experimental
Experimental
Active Comparator
Low Dose DR-1031
Midrange Dose DR-1031
High Dose DR-1031
Seasonale
42 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 21 days combination active tablets (25 mcg EE/150 mcg LNG) followed by 21 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
21 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 42 days combination active tablets (25 mcg EE/ 150 mcg LNG) followed by 21 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
21 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 21 days combination active tablets (25 mcg EE/150 mcg LNG) followed by 42 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
84 days of combination active tablets, each containing 30 mcg EE and 150 mcg LNG, followed by 7 days of placebo tablets.