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

Breakthrough Bleeding Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00394771
• Other study ID #: DR-ASC-201
• Status: Completed
• Phase: Phase 2
• First received: October 30, 2006
• Last updated: July 12, 2013
• Start date: October 2006
• Est. completion date: March 2008

Study information

• Verified date: July 2013
• Source: Teva Pharmaceutical Industries
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

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 information / eligibility

• Status: Completed
• Enrollment: 567
• Est. completion date: March 2008
• Est. primary completion date: March 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Breakthrough Bleeding
• Hemorrhage
• Metrorrhagia

Intervention

Drug:
• DR-1031
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.
• Seasonale®
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.
• Portia®
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.

Locations

Country	Name	City	State
United States	Duramed Investigational Site	Alpharetta	Georgia
United States	Duramed Investigational Site	Austin	Texas
United States	Duramed Investigational Site	Baton Rouge	Louisiana
United States	Duramed Investigational Site	Boise	Idaho
United States	Duramed Investigational Site	Cary	North Carolina
United States	Duramed Investigational Site	Charleston	South Carolina
United States	Duramed Investigational Site	Cleveland	Ohio
United States	Duramed Investigational Site	Columbia	South Carolina
United States	Duramed Investigational Site	Dallas	Texas
United States	Duramed Investigational Site	Deland	Florida
United States	Duramed Investigational Site	Douglasville	Georgia
United States	Duramed Investigational Site	Eugene	Oregon
United States	Duramed Investigational Site	Fort Wayne	Indiana
United States	Duramed Investigational Site	Hilton Head Island	South Carolina
United States	Duramed Investigational Site	Houston	Texas
United States	Duramed Investigational Site	Huntsville	Alabama
United States	Duramed Investigational Site	Jackson	Tennessee
United States	Duramed Investigational Site	Jacksonville	Florida
United States	Duramed Investigational Site	Kansas City	Missouri
United States	Duramed Investigational Site	Las Vegas	Nevada
United States	Duramed Investigational Site	Las Vegas	Nevada
United States	Duramed Investigational Site	Lebanon	New Hampshire
United States	Duramed Investigational Site	Little Rock	Arkansas
United States	Duramed Investigational Site	Mayfield Heights	Ohio
United States	Duramed Investigational Site	Medford	Oregon
United States	Duramed Investigational Site	Melbourne	Florida
United States	Duramed Investigational Site	Meridian	Idaho
United States	Duramed Investigational Site	Metairie	Louisiana
United States	Duramed Investigational Site	Miami	Florida
United States	Duramed Investigational Site	N. Las Vegas	Nevada
United States	Duramed Investigational Site	New Bern	North Carolina
United States	Duramed Investigational Site	Pittsburgh	Pennsylvania
United States	Duramed Investigational Site	Pueblo	Colorado
United States	Duramed Investigational Site	Riverdale	Maryland
United States	Duramed Investigational Site	Salt Lake City	Utah
United States	Duramed Investigational Site	San Antonio	Texas
United States	Duramed Investigational Site	San Diego	California
United States	Duramed Investigational Site	San Francisco	California
United States	Duramed Investigational Site	Santa Ana	California
United States	Duramed Investigational Site	Savannah	Georgia
United States	Duramed Investigational Site	Shreveport	Louisiana
United States	Duramed Investigational Site	Stratford	Connecticut
United States	Duramed Investigational Site	Tampa	Florida
United States	Duramed Investigational Site	Tucson	Arizona
United States	Duramed Investigational Site	Vista	California
United States	Duramed Investigational Site	West Palm Beach	Florida
United States	Duramed Investigational Site	West Palm Beach	Florida
United States	Duramed Investigational Site	Wichita	Kansas
United States	Duramed Investigational Site	Williston	Vermont
United States	Duramed Investigational Site	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duramed Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	No
Other	Number of Moderate to Heavy Bleeding Days During Active Cycle 2 (Day 92-176)	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 92-176	No
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.	Day 1-84	No
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.	Day 92-176	No
Secondary	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	No
Secondary	Days With Bleeding During Active Cycle 2 (Day 92-176)	Bleeding is defined as a flow heavy enough to require sanitary protection.	Day 92-176	No
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.	Day 1-84	No
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.	Day 1-84	No
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.	Day 85-91	No
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.	Day 177-183	No
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.	Day 1-84	Yes
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.	Day 92-176	Yes
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.	Day 85-91	Yes
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.	Day 177-183	Yes