A Study to Evaluate Bleeding Patterns With Three Different Doses of DR-1031 Compared to Seasonale

Phase 2

Completed

Conditions: Breakthrough Bleeding

Interventions: Drug: Seasonale®
Drug: DR-1031
Drug: Portia®

Registration Number: NCT00394771

Lead Sponsor: Duramed Research

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 567

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Midrange Dose DR-1031	Portia®	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.
High Dose DR-1031	Portia®	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.
Seasonale	Seasonale®	84 days of combination active tablets, each containing 30 mcg EE and 150 mcg LNG, followed by 7 days of placebo tablets.
Seasonale	Portia®	84 days of combination active tablets, each containing 30 mcg EE and 150 mcg LNG, followed by 7 days of placebo tablets.
Low Dose DR-1031	Portia®	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.
Low Dose DR-1031	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.
Midrange Dose DR-1031	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.
High Dose DR-1031	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.

Primary Outcome Measures

Name	Time	Method
Days With Bleeding and/or Spotting During Active Cycle 1 (Day 1-84)	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)	Day 92-176	Bleeding is defined as a flow heavy enough to require sanitary protection. Spotting does not require sanitary protection.

Secondary Outcome Measures

Name	Time	Method
Days With Bleeding During Active Cycle 1 (Day 1-84)	Day 1-84	Bleeding is defined as a flow heavy enough to require sanitary protection.
Days With Bleeding During Active Cycle 2 (Day 92-176)	Day 92-176	Bleeding is defined as a flow heavy enough to require sanitary protection.
Time to First Bleeding Day	Day 1-84	Time to first bleeding day was defined as the time between the start of intervention until the first day when bleeding was heavy enough to require the use of sanitary protection. Data are not summarized due to limitations in the diary data and an inability to accurately determine a participant's first day of bleeding.
Maximum Bleeding Severity During Active Cycle 1 (Day 1-84)	Day 1-84	Bleeding is defined as a flow heavy enough to require sanitary protection. Participants recorded in the diary days when they had bleeding, and whether they considered the bleeding to be light, moderate or heavy. Data was not summarized due to limitations in the diary data, and an inability to accurately determine the maximum bleeding severity. See pre-specified analyses for Number of Moderate to Heavy Bleeding Days.
Participants With Bleeding and/or Spotting Days During the 7-day Withdrawal During Cycle 1 (Day 85-91)	Day 85-91	Participants are categorized by the duration of bleeding that occurred during the scheduled 7-day withdrawal period for Cycle 1.
Participants With Bleeding and/or Spotting Days During the 7-day Withdrawal During Cycle 2 (Day 177-183)	Day 177-183	Participants are categorized by the duration of bleeding that occurred during the scheduled 7-day withdrawal period for Cycle 2.
Participants Reporting Hormone-Related Symptoms During Active Cycle 1 (Day 1-84)	Day 1-84	Hormone-related symptoms include breast tenderness/pain, headache, bloating, pelvic pain, anxiety, depression, and irritability.
Participants Reporting Hormone-Related Symptoms During Active Cycle 2 (Day 92-176)	Day 92-176	Hormone-related symptoms include breast tenderness/pain, headache, bloating, pelvic pain, anxiety, depression, and irritability.
Participants Reporting Hormone-Related Symptoms During the 7-day Withdrawal Cycle 1 (Day 85-91)	Day 85-91	Hormone-related symptoms include breast tenderness/pain, headache, bloating, pelvic pain, anxiety, depression, and irritability.
Participants Reporting Hormone-Related Symptoms During the 7-day Withdrawal Cycle 2 (Day 177-183)	Day 177-183	Hormone-related symptoms include breast tenderness/pain, headache, bloating, pelvic pain, anxiety, depression, and irritability.