A Prospective, Multicenter, Double-Blinded, Randomized Study to Evaluate Bleeding Patterns in Women Using One of Three Different Doses of DR-1031 Oral Contraceptive Compared to Seasonale Oral Contraceptive Regimen
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Duramed Research
- Enrollment
- 567
- Locations
- 1
- Primary Endpoint
- Days With Bleeding and/or Spotting During Active Cycle 1 (Day 1-84)
Study Overview
Brief Summary
This is a 4-arm study to evaluate and compare bleeding patterns between three different doses of DR-1031 oral contraceptive with Seasonale oral contraceptive. Study participants will receive physical and gynecological exams, including Pap smear. During the study, all participants will be required to complete a diary
Detailed Description
This Phase 2, prospective, multicenter, double-blinded, randomized study is designed to evaluate and compare bleeding patterns in women using one of three different doses of DR-1031 oral contraceptive with Seasonale oral contraceptive.
Patients who meet all study entrance criteria will be randomly assigned to one of four treatment groups,
The overall study duration will be approximately 9 months; this will include a screening period of approximately 4 weeks, a run-in period of 4 weeks, a treatment period of approximately 6 months (two,91-day cycles) and a final study visit occurring 14-21 days after completion of study drug.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
Low Dose DR-1031
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.
Intervention: DR-1031 (Drug)
Low Dose DR-1031
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.
Intervention: Portia® (Drug)
Midrange Dose DR-1031
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.
Intervention: DR-1031 (Drug)
Midrange Dose DR-1031
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.
Intervention: Portia® (Drug)
High Dose DR-1031
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.
Intervention: DR-1031 (Drug)
High Dose DR-1031
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.
Intervention: Portia® (Drug)
Seasonale
84 days of combination active tablets, each containing 30 mcg EE and 150 mcg LNG, followed by 7 days of placebo tablets.
Intervention: Seasonale® (Drug)
Seasonale
84 days of combination active tablets, each containing 30 mcg EE and 150 mcg LNG, followed by 7 days of placebo tablets.
Intervention: Portia® (Drug)
Outcomes
Primary Outcomes
Days With Bleeding and/or Spotting During Active Cycle 1 (Day 1-84)
Time Frame: Day 1-84
Bleeding is defined as a flow heavy enough to require sanitary protection. Spotting does not require sanitary protection.
Days With Bleeding and/or Spotting During Active Cycle 2 (Day 92-176)
Time Frame: Day 92-176
Bleeding is defined as a flow heavy enough to require sanitary protection. Spotting does not require sanitary protection.
Secondary Outcomes
- Days With Bleeding During Active Cycle 1 (Day 1-84)(Day 1-84)
- Days With Bleeding During Active Cycle 2 (Day 92-176)(Day 92-176)
- Time to First Bleeding Day(Day 1-84)
- Maximum Bleeding Severity During Active Cycle 1 (Day 1-84)(Day 1-84)
- Participants With Bleeding and/or Spotting Days During the 7-day Withdrawal During Cycle 1 (Day 85-91)(Day 85-91)
- Participants With Bleeding and/or Spotting Days During the 7-day Withdrawal During Cycle 2 (Day 177-183)(Day 177-183)
- Participants Reporting Hormone-Related Symptoms During Active Cycle 1 (Day 1-84)(Day 1-84)
- Participants Reporting Hormone-Related Symptoms During Active Cycle 2 (Day 92-176)(Day 92-176)
- Participants Reporting Hormone-Related Symptoms During the 7-day Withdrawal Cycle 1 (Day 85-91)(Day 85-91)
- Participants Reporting Hormone-Related Symptoms During the 7-day Withdrawal Cycle 2 (Day 177-183)(Day 177-183)