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

Primary Purpose

Breakthrough Bleeding

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
DR-1031
Seasonale®
Portia®
Sponsored by
Duramed Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Breakthrough Bleeding focused on measuring oral contraceptives, breakthrough bleeding, spotting

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

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
  • 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
  • Duramed Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Active Comparator

Arm Label

Low Dose DR-1031

Midrange Dose DR-1031

High Dose DR-1031

Seasonale

Arm Description

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Days With Bleeding During Active Cycle 1 (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)
Bleeding is defined as a flow heavy enough to require sanitary protection.
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.
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.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
October 30, 2006
Last Updated
July 12, 2013
Sponsor
Duramed Research
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1. Study Identification

Unique Protocol Identification Number
NCT00394771
Brief Title
A Study to Evaluate Bleeding Patterns With Three Different Doses of DR-1031 Compared to Seasonale
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2013
Overall Recruitment Status
Completed
Study Start Date
October 2006 (undefined)
Primary Completion Date
March 2008 (Actual)
Study Completion Date
March 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duramed Research

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breakthrough Bleeding
Keywords
oral contraceptives, breakthrough bleeding, spotting

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
567 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Low Dose DR-1031
Arm Type
Experimental
Arm Description
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.
Arm Title
Midrange Dose DR-1031
Arm Type
Experimental
Arm Description
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.
Arm Title
High Dose DR-1031
Arm Type
Experimental
Arm Description
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 Title
Seasonale
Arm Type
Active Comparator
Arm Description
84 days of combination active tablets, each containing 30 mcg EE and 150 mcg LNG, followed by 7 days of placebo tablets.
Intervention Type
Drug
Intervention Name(s)
DR-1031
Other Intervention Name(s)
levonorgestrel/ethinyl estradiol, Quartette®
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Seasonale®
Other Intervention Name(s)
levonorgestrel/ethinyl estradiol
Intervention Description
84 days of combination active tablets, each containing 30 mcg EE and 150 mcg LNG, followed by 7 days of placebo tablets for two consecutive 91-day cycles.
Intervention Type
Drug
Intervention Name(s)
Portia®
Other Intervention Name(s)
levonorgestrel/ethinyl estradiol
Intervention Description
Portia® 28 consists of 21 pink active tablets, each containing 0.15 mg of levonorgestrel and 0.03 mg of ethinyl estradiol, and seven white inert tablets. Portia was taken as a pre-study run-in medication.
Primary Outcome Measure Information:
Title
Days With Bleeding and/or Spotting During Active Cycle 1 (Day 1-84)
Description
Bleeding is defined as a flow heavy enough to require sanitary protection. Spotting does not require sanitary protection.
Time Frame
Day 1-84
Title
Days With Bleeding and/or Spotting During Active Cycle 2 (Day 92-176)
Description
Bleeding is defined as a flow heavy enough to require sanitary protection. Spotting does not require sanitary protection.
Time Frame
Day 92-176
Secondary Outcome Measure Information:
Title
Days With Bleeding During Active Cycle 1 (Day 1-84)
Description
Bleeding is defined as a flow heavy enough to require sanitary protection.
Time Frame
Day 1-84
Title
Days With Bleeding During Active Cycle 2 (Day 92-176)
Description
Bleeding is defined as a flow heavy enough to require sanitary protection.
Time Frame
Day 92-176
Title
Time to First Bleeding Day
Description
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.
Time Frame
Day 1-84
Title
Maximum Bleeding Severity During Active Cycle 1 (Day 1-84)
Description
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.
Time Frame
Day 1-84
Title
Participants With Bleeding and/or Spotting Days During the 7-day Withdrawal During Cycle 1 (Day 85-91)
Description
Participants are categorized by the duration of bleeding that occurred during the scheduled 7-day withdrawal period for Cycle 1.
Time Frame
Day 85-91
Title
Participants With Bleeding and/or Spotting Days During the 7-day Withdrawal During Cycle 2 (Day 177-183)
Description
Participants are categorized by the duration of bleeding that occurred during the scheduled 7-day withdrawal period for Cycle 2.
Time Frame
Day 177-183
Title
Participants Reporting Hormone-Related Symptoms During Active Cycle 1 (Day 1-84)
Description
Hormone-related symptoms include breast tenderness/pain, headache, bloating, pelvic pain, anxiety, depression, and irritability.
Time Frame
Day 1-84
Title
Participants Reporting Hormone-Related Symptoms During Active Cycle 2 (Day 92-176)
Description
Hormone-related symptoms include breast tenderness/pain, headache, bloating, pelvic pain, anxiety, depression, and irritability.
Time Frame
Day 92-176
Title
Participants Reporting Hormone-Related Symptoms During the 7-day Withdrawal Cycle 1 (Day 85-91)
Description
Hormone-related symptoms include breast tenderness/pain, headache, bloating, pelvic pain, anxiety, depression, and irritability.
Time Frame
Day 85-91
Title
Participants Reporting Hormone-Related Symptoms During the 7-day Withdrawal Cycle 2 (Day 177-183)
Description
Hormone-related symptoms include breast tenderness/pain, headache, bloating, pelvic pain, anxiety, depression, and irritability.
Time Frame
Day 177-183
Other Pre-specified Outcome Measures:
Title
Number of Moderate to Heavy Bleeding Days During Active Cycle 1 (Day 1-84)
Description
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.
Time Frame
Day 1-84
Title
Number of Moderate to Heavy Bleeding Days During Active Cycle 2 (Day 92-176)
Description
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.
Time Frame
Day 92-176

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Duramed Medical Monitor
Organizational Affiliation
Duramed Research
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duramed Investigational Site
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35801
Country
United States
Facility Name
Duramed Investigational Site
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85741
Country
United States
Facility Name
Duramed Investigational Site
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Duramed Investigational Site
City
San Diego
State/Province
California
ZIP/Postal Code
92108
Country
United States
Facility Name
Duramed Investigational Site
City
San Francisco
State/Province
California
ZIP/Postal Code
94102
Country
United States
Facility Name
Duramed Investigational Site
City
Santa Ana
State/Province
California
ZIP/Postal Code
92705
Country
United States
Facility Name
Duramed Investigational Site
City
Vista
State/Province
California
ZIP/Postal Code
92083
Country
United States
Facility Name
Duramed Investigational Site
City
Pueblo
State/Province
Colorado
ZIP/Postal Code
81001
Country
United States
Facility Name
Duramed Investigational Site
City
Stratford
State/Province
Connecticut
ZIP/Postal Code
06615
Country
United States
Facility Name
Duramed Investigational Site
City
Deland
State/Province
Florida
ZIP/Postal Code
32720
Country
United States
Facility Name
Duramed Investigational Site
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32207
Country
United States
Facility Name
Duramed Investigational Site
City
Melbourne
State/Province
Florida
ZIP/Postal Code
32935
Country
United States
Facility Name
Duramed Investigational Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33186
Country
United States
Facility Name
Duramed Investigational Site
City
Tampa
State/Province
Florida
ZIP/Postal Code
33607
Country
United States
Facility Name
Duramed Investigational Site
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33401
Country
United States
Facility Name
Duramed Investigational Site
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33407
Country
United States
Facility Name
Duramed Investigational Site
City
Alpharetta
State/Province
Georgia
ZIP/Postal Code
30005
Country
United States
Facility Name
Duramed Investigational Site
City
Douglasville
State/Province
Georgia
ZIP/Postal Code
30134
Country
United States
Facility Name
Duramed Investigational Site
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31406
Country
United States
Facility Name
Duramed Investigational Site
City
Boise
State/Province
Idaho
ZIP/Postal Code
83712
Country
United States
Facility Name
Duramed Investigational Site
City
Meridian
State/Province
Idaho
ZIP/Postal Code
83642
Country
United States
Facility Name
Duramed Investigational Site
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46825
Country
United States
Facility Name
Duramed Investigational Site
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67205
Country
United States
Facility Name
Duramed Investigational Site
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70808
Country
United States
Facility Name
Duramed Investigational Site
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70006
Country
United States
Facility Name
Duramed Investigational Site
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71106
Country
United States
Facility Name
Duramed Investigational Site
City
Riverdale
State/Province
Maryland
ZIP/Postal Code
20737
Country
United States
Facility Name
Duramed Investigational Site
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64114
Country
United States
Facility Name
Duramed Investigational Site
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89109
Country
United States
Facility Name
Duramed Investigational Site
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89128
Country
United States
Facility Name
Duramed Investigational Site
City
N. Las Vegas
State/Province
Nevada
ZIP/Postal Code
89030
Country
United States
Facility Name
Duramed Investigational Site
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
Facility Name
Duramed Investigational Site
City
Cary
State/Province
North Carolina
ZIP/Postal Code
27511
Country
United States
Facility Name
Duramed Investigational Site
City
New Bern
State/Province
North Carolina
ZIP/Postal Code
28562
Country
United States
Facility Name
Duramed Investigational Site
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Duramed Investigational Site
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44122
Country
United States
Facility Name
Duramed Investigational Site
City
Mayfield Heights
State/Province
Ohio
ZIP/Postal Code
44124
Country
United States
Facility Name
Duramed Investigational Site
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97401
Country
United States
Facility Name
Duramed Investigational Site
City
Medford
State/Province
Oregon
ZIP/Postal Code
97504
Country
United States
Facility Name
Duramed Investigational Site
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15206
Country
United States
Facility Name
Duramed Investigational Site
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Duramed Investigational Site
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29201
Country
United States
Facility Name
Duramed Investigational Site
City
Hilton Head Island
State/Province
South Carolina
ZIP/Postal Code
29926
Country
United States
Facility Name
Duramed Investigational Site
City
Jackson
State/Province
Tennessee
ZIP/Postal Code
38305
Country
United States
Facility Name
Duramed Investigational Site
City
Austin
State/Province
Texas
ZIP/Postal Code
78737
Country
United States
Facility Name
Duramed Investigational Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
Duramed Investigational Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77024
Country
United States
Facility Name
Duramed Investigational Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Duramed Investigational Site
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84102
Country
United States
Facility Name
Duramed Investigational Site
City
Williston
State/Province
Vermont
ZIP/Postal Code
05495
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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