A Study to Evaluate Bleeding Patterns With Three Differen... | NCT00394771

NCT00394771

Status Module

Sponsor/Collaborators Module

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Low Dose DR-1031	Experimental	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.	Drug: DR-1031 Drug: Portia®
Midrange Dose DR-1031	Experimental	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.	Drug: DR-1031 Drug: Portia®
High Dose DR-1031	Experimental	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.	Drug: DR-1031 Drug: Portia®
Seasonale	Active Comparator	84 days of combination active tablets, each containing 30 mcg EE and 150 mcg LNG, followed by 7 days of placebo tablets.	Drug: Seasonale® Drug: Portia®

Interventions

Name	Type	Description	Arm Group Labels	Other Names
DR-1031	Drug	Active therapy cycle of 84 days taking combination tablets containing ascending doses of ethinyl estradiol (EE) and 150 mcg levonorgestrel (LNG), followed by a 7-day withdrawal cycle of 10 mcg EE. The total extended cycle was 91 days and participants were to complete two extended cycles. Active therapy dosage of EE varied by treatment arm.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Days With Bleeding and/or Spotting During Active Cycle 1 (Day 1-84)	Bleeding is defined as a flow heavy enough to require sanitary protection. Spotting does not require sanitary protection.	Day 1-84
Days With Bleeding and/or Spotting During Active Cycle 2 (Day 92-176)	Bleeding is defined as a flow heavy enough to require sanitary protection. Spotting does not require sanitary protection.	Day 92-176

Secondary Outcomes

Measure	Description	Time Frame
Days With Bleeding During Active Cycle 1 (Day 1-84)	Bleeding is defined as a flow heavy enough to require sanitary protection.	Day 1-84
Days With Bleeding During Active Cycle 2 (Day 92-176)

Other Outcomes

Measure	Description	Time Frame
Number of Moderate to Heavy Bleeding Days During Active Cycle 1 (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.	Day 1-84
Number of Moderate to Heavy Bleeding Days During Active Cycle 2 (Day 92-176)

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Duramed Medical Monitor	Duramed Research	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Duramed Investigational Site		Huntsville	Alabama	35801	United States
Duramed Investigational Site

References Module

No data available

No data is available for this block.

IPD Sharing Statement Module

No data available

No data is available for this block.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	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.
FG001	Midrange Dose DR-1031

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

Masking Info

Bleeding is defined as a flow heavy enough to require sanitary protection.

FG000140 subjectsSafety population of treated participants

FG001136 subjectsSafety population of treated participants

FG002143 subjectsSafety population of treated participants

FG003148 subjectsSafety population of treated participants

Arm/Group Information

ID	Title	Description
BG000	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.
BG001	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.
BG002	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.
BG003	Seasonale	84 days of combination active tablets, each containing 30 mcg EE and 150 mcg LNG, followed by 7 days of placebo tablets.
BG004	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00030.1± 6.88 BG00130.5± 7.02 BG00230.7± 7.61 BG003

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG000110 BG001110 BG002

Race/Ethnicity, Customized

Number

participants

Title

Denominators

Categories

African-American

Title	Measurements
	BG00021 BG00120 BG002

Weight

Mean

Standard Deviation

lbs

Title

Denominators

Categories

Title	Measurements
	BG000156.6± 28.84 BG001153.6± 27.18 BG002

Body Mass Index

Mean

Standard Deviation

kg/m^2

Title

Denominators

Categories

Title	Measurements
	BG00026.6± 4.13 BG00125.7± 4.24 BG002

Systolic Blood Pressure

Mean

Standard Deviation

mmHg

Title

Denominators

Categories

Title	Measurements
	BG000114.2± 10.74 BG001114.4± 10.34 BG002

Diastolic Blood Pressure

Mean

Standard Deviation

mmHg

Title

Denominators

Categories

Title	Measurements
	BG00072.3± 8.85 BG00172.9± 7.46 BG002

Heart Rate

Mean

Standard Deviation

beats/minute

Title

Denominators

Categories

Title	Measurements
	BG00073.9± 9.85 BG00173.7± 8.90 BG002

Smoking Status

Number

participants

Title

Denominators

Categories

Current Smoker

Title	Measurements
	BG00013 BG00116 BG002

Oral Contraceptive Use History

Number

participants

Title

Denominators

Categories

Missing

Title	Measurements
	BG0001 BG0010 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Days With Bleeding and/or Spotting During Active Cycle 1 (Day 1-84)

Bleeding is defined as a flow heavy enough to require sanitary protection. Spotting does not require sanitary protection.

Intent to treat (ITT) population of participants who completed the relevant pages in the patient diary.

Posted

Median

Full Range

days

Day 1-84

ID	Title	Description
OG000	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.
OG001	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.
OG002	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.
OG003	Seasonale	84 days of combination active tablets, each containing 30 mcg EE and 150 mcg LNG, followed by 7 days of placebo tablets.

Units	Counts
Participants	OG000110 OG001110 OG002108 OG003

Title

Denominators

Categories

Title	Measurements
	OG00013(0 to 67) OG00113.5(0 to 65) OG00215(0 to 69) OG003

Secondary

Days With Bleeding During Active Cycle 1 (Day 1-84)

Bleeding is defined as a flow heavy enough to require sanitary protection.

Intent to treat (ITT) population of participants who completed the relevant pages in the patient diary.

Posted

Median

Full Range

days

Day 1-84

ID	Title	Description
OG000	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.
OG001	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.
OG002	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.

Secondary

Days With Bleeding During Active Cycle 2 (Day 92-176)

Bleeding is defined as a flow heavy enough to require sanitary protection.

Intent to treat (ITT) population of participants who were still active in the study and who completed the relevant pages in the patient diary.

Posted

Median

Full Range

days

Day 92-176

ID	Title	Description
OG000	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.
OG001	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.
OG002	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.

Secondary

Time to First Bleeding Day

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.

ITT population. However this data was not summarized due to limitations in the diary data.

Posted

Day 1-84

ID	Title	Description
OG000	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.
OG001	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.
OG002	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.

Secondary

Maximum Bleeding Severity During Active Cycle 1 (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.

ITT population. However data was not summarized due to limitations in the diary data.

Posted

Day 1-84

ID	Title	Description
OG000	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.
OG001	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.
OG002	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.

Primary

Days With Bleeding and/or Spotting During Active Cycle 2 (Day 92-176)

Bleeding is defined as a flow heavy enough to require sanitary protection. Spotting does not require sanitary protection.

Intent to treat (ITT) population of participants who were still active in the study and who completed the relevant pages in the patient diary.

Posted

Median

Full Range

days

Day 92-176

ID	Title	Description
OG000	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.
OG001	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.
OG002	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.

Secondary

Participants With Bleeding and/or Spotting Days During the 7-day Withdrawal During Cycle 1 (Day 85-91)

Participants are categorized by the duration of bleeding that occurred during the scheduled 7-day withdrawal period for Cycle 1.

Intent to treat (ITT) population of participants who completed the relevant pages in the patient diary.

Posted

Number

participants

Day 85-91

ID	Title	Description
OG000	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.
OG001	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.
OG002	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.

Secondary

Participants With Bleeding and/or Spotting Days During the 7-day Withdrawal During Cycle 2 (Day 177-183)

Participants are categorized by the duration of bleeding that occurred during the scheduled 7-day withdrawal period for Cycle 2.

Intent to treat (ITT) population of participants who were still active in the study and who completed the relevant pages in the patient diary.

Posted

Number

participants

Day 177-183

ID	Title	Description
OG000	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.
OG001	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.
OG002	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.

Secondary

Participants Reporting Hormone-Related Symptoms During Active Cycle 1 (Day 1-84)

Hormone-related symptoms include breast tenderness/pain, headache, bloating, pelvic pain, anxiety, depression, and irritability.

Intent to treat (ITT) population of participants who completed the relevant pages in the patient diary.

Posted

Number

participants

Day 1-84

ID	Title	Description
OG000	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.
OG001	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.
OG002	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.

Secondary

Participants Reporting Hormone-Related Symptoms During Active Cycle 2 (Day 92-176)

Hormone-related symptoms include breast tenderness/pain, headache, bloating, pelvic pain, anxiety, depression, and irritability.

Intent to treat (ITT) population of participants who were still active in the study and who completed the relevant pages in the patient diary.

Posted

Number

participants

Day 92-176

ID	Title	Description
OG000	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.
OG001	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.
OG002	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.

Secondary

Participants Reporting Hormone-Related Symptoms During the 7-day Withdrawal Cycle 1 (Day 85-91)

Hormone-related symptoms include breast tenderness/pain, headache, bloating, pelvic pain, anxiety, depression, and irritability.

Intent to treat (ITT) population of participants who completed the relevant pages in the patient diary.

Posted

Number

participants

Day 85-91

ID	Title	Description
OG000	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.
OG001	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.
OG002	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.

Secondary

Participants Reporting Hormone-Related Symptoms During the 7-day Withdrawal Cycle 2 (Day 177-183)

Hormone-related symptoms include breast tenderness/pain, headache, bloating, pelvic pain, anxiety, depression, and irritability.

Intent to treat (ITT) population of participants who were still active in the study and who completed the relevant pages in the patient diary.

Posted

Number

participants

Day 177-183

ID	Title	Description
OG000	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.
OG001	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.
OG002	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.

Other Pre-specified

Number of Moderate to Heavy Bleeding Days During Active Cycle 1 (Day 1-84)

Intent to treat (ITT) population of participants who completed the relevant pages in the patient diary.

Posted

Median

Full Range

days

Day 1-84

ID	Title	Description
OG000	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.
OG001	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.
OG002	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.

Other Pre-specified

Number of Moderate to Heavy Bleeding Days During Active Cycle 2 (Day 92-176)

Intent to treat (ITT) population of participants who were still active in the study and who completed the relevant pages in the patient diary.

Posted

Median

Full Range

days

Day 92-176

ID	Title	Description
OG000	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.
OG001	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.
OG002	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.

Arm/Groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	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.	1	140	61	140
EG001	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.	2	136	44	136
EG002	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.	3	143	49	143
EG003	Seasonale	84 days of combination active tablets, each containing 30 mcg EE and 150 mcg LNG, followed by 7 days of placebo tablets.	5	148	53	148

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Small intestinal obstruction	Gastrointestinal disorders	MedDRA 9.0	Systematic Assessment	EG0000 affected140 at risk EG0010 affected136 at risk EG0020 affected143 at risk EG0031 affected148 at risk
Vomiting	Gastrointestinal disorders	MedDRA 9.0	Systematic Assessment	EG0000 affected140 at risk EG0010 affected136 at risk EG0020 affected143 at risk EG003
Cholecystitis	Hepatobiliary disorders	MedDRA 9.0	Systematic Assessment	EG0000 affected140 at risk EG0011 affected136 at risk EG0020 affected143 at risk EG003
Pyelonephritis	Infections and infestations	MedDRA 9.0	Systematic Assessment	EG0000 affected140 at risk EG0011 affected136 at risk EG0020 affected143 at risk EG003
Road traffic accident	Injury, poisoning and procedural complications	MedDRA 9.0	Systematic Assessment	EG0000 affected140 at risk EG0010 affected136 at risk EG0020 affected143 at risk EG003
Multiple fractures	Injury, poisoning and procedural complications	MedDRA 9.0	Systematic Assessment	EG0000 affected140 at risk EG0010 affected136 at risk EG0020 affected143 at risk EG003
Polytraumatism	Injury, poisoning and procedural complications	MedDRA 9.0	Systematic Assessment	EG0000 affected140 at risk EG0010 affected136 at risk EG0020 affected143 at risk EG003
Post procedural bile leak	Injury, poisoning and procedural complications	MedDRA 9.0	Systematic Assessment	EG0000 affected140 at risk EG0011 affected136 at risk EG0020 affected143 at risk EG003
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA 9.0	Systematic Assessment	EG0000 affected140 at risk EG0010 affected136 at risk EG0021 affected143 at risk EG003
Hemiparesis	Nervous system disorders	MedDRA 9.0	Systematic Assessment	EG0001 affected140 at risk EG0010 affected136 at risk EG0020 affected143 at risk EG003
Hypoaesthesia	Nervous system disorders	MedDRA 9.0	Systematic Assessment	EG0001 affected140 at risk EG0010 affected136 at risk EG0020 affected143 at risk EG003
Ectopic pregnancy	Pregnancy, puerperium and perinatal conditions	MedDRA 9.0	Systematic Assessment	EG0000 affected140 at risk EG0010 affected136 at risk EG0020 affected143 at risk EG003
Abortion spontaneous	Pregnancy, puerperium and perinatal conditions	MedDRA 9.0	Systematic Assessment	EG0000 affected140 at risk EG0010 affected136 at risk EG0022 affected143 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Headache	Nervous system disorders	MedDRA 9.0	Systematic Assessment	EG00019 affected140 at risk EG00119 affected136 at risk EG00223 affected143 at risk EG00319 affected148 at risk
Migraine	Nervous system disorders	MedDRA 9.0	Systematic Assessment	EG0002 affected140 at risk EG0017 affected136 at risk EG0021 affected143 at risk EG003
Nasopharyngitis	Infections and infestations	MedDRA 9.0	Systematic Assessment	EG00015 affected140 at risk EG0017 affected136 at risk EG0028 affected143 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA 9.0	Systematic Assessment	EG0009 affected140 at risk EG0017 affected136 at risk EG0025 affected143 at risk EG003
Sinusitis	Infections and infestations	MedDRA 9.0	Systematic Assessment	EG00010 affected140 at risk EG0016 affected136 at risk EG0022 affected143 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA 9.0	Systematic Assessment	EG0008 affected140 at risk EG0011 affected136 at risk EG0025 affected143 at risk EG003
Dysmenorrhoea	Reproductive system and breast disorders	MedDRA 9.0	Systematic Assessment	EG00013 affected140 at risk EG0016 affected136 at risk EG0025 affected143 at risk EG003
Weight increased	Investigations	MedDRA 9.0	Systematic Assessment	EG0006 affected140 at risk EG0014 affected136 at risk EG0029 affected143 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 9.0	Systematic Assessment	EG0007 affected140 at risk EG0017 affected136 at risk EG0025 affected143 at risk EG003

ID	Term
D008796	Metrorrhagia

Ancestor Terms

ID	Term
D014592	Uterine Hemorrhage
D014591	Uterine Diseases
D005831	Genital Diseases, Female
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases
D000091662	Genital Diseases
D006470	Hemorrhage
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
D019304	Ethinyl Estradiol-Norgestrel Combination
C482584	Seasonale

Ancestor Terms

ID	Term
D004997	Ethinyl Estradiol
D009651	Norpregnatrienes
D009650	Norpregnanes
D009654	Norsteroids
D013256	Steroids
D000072473	Fused-Ring Compounds
D011083	Polycyclic Compounds
D009644	Norgestrel
D009652	Norpregnenes
D042782	Estrogenic Steroids, Alkylated
D045166	Estradiol Congeners
D012739	Gonadal Steroid Hormones
D042341	Gonadal Hormones
D006728	Hormones
D006730	Hormones, Hormone Substitutes, and Hormone Antagonists