Clinical trial NCT00394771: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Breakthrough Bleeding
Keywords: oral contraceptives
breakthrough bleeding
spotting
Lead sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Sponsor class: INDUSTRY
First posted: 2006-11-01
Enrollment: 567
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Days With Bleeding and/or Spotting During Active Cycle 1 (Day 1-84)
timeFrame: Day 1-84
measure: Days With Bleeding and/or Spotting During Active Cycle 2 (Day 92-176)
timeFrame: Day 92-176
Secondary outcomes:
measure: Days With Bleeding During Active Cycle 1 (Day 1-84)
timeFrame: Day 1-84
measure: Days With Bleeding During Active Cycle 2 (Day 92-176)
timeFrame: Day 92-176
measure: Time to First Bleeding Day
timeFrame: Day 1-84
measure: Maximum Bleeding Severity During Active Cycle 1 (Day 1-84)
timeFrame: Day 1-84
measure: Participants With Bleeding and/or Spotting Days During the 7-day Withdrawal During Cycle 1 (Day 85-91)
timeFrame: Day 85-91
measure: Participants With Bleeding and/or Spotting Days During the 7-day Withdrawal During Cycle 2 (Day 177-183)
timeFrame: Day 177-183
measure: Participants Reporting Hormone-Related Symptoms During Active Cycle 1 (Day 1-84)
timeFrame: Day 1-84
measure: Participants Reporting Hormone-Related Symptoms During Active Cycle 2 (Day 92-176)
timeFrame: Day 92-176
measure: Participants Reporting Hormone-Related Symptoms During the 7-day Withdrawal Cycle 1 (Day 85-91)
timeFrame: Day 85-91
measure: Participants Reporting Hormone-Related Symptoms During the 7-day Withdrawal Cycle 2 (Day 177-183)
timeFrame: Day 177-183
Other outcomes:
measure: Number of Moderate to Heavy Bleeding Days During Active Cycle 1 (Day 1-84)
timeFrame: Day 1-84
measure: Number of Moderate to Heavy Bleeding Days During Active Cycle 2 (Day 92-176)
timeFrame: Day 92-176
Locations:
city: Huntsville
country: United States
facility: Duramed Investigational Site
state: Alabama
city: Tucson
country: United States
facility: Duramed Investigational Site
state: Arizona
city: Little Rock
country: United States
facility: Duramed Investigational Site
state: Arkansas
city: San Diego
country: United States
facility: Duramed Investigational Site
state: California
city: San Francisco
country: United States
facility: Duramed Investigational Site
state: California
city: Santa Ana
country: United States
facility: Duramed Investigational Site
state: California
city: Vista
country: United States
facility: Duramed Investigational Site
state: California
city: Pueblo
country: United States
facility: Duramed Investigational Site
state: Colorado
city: Stratford
country: United States
facility: Duramed Investigational Site
state: Connecticut
city: Deland
country: United States
facility: Duramed Investigational Site
state: Florida
city: Jacksonville
country: United States
facility: Duramed Investigational Site
state: Florida
city: Melbourne
country: United States
facility: Duramed Investigational Site
state: Florida
city: Miami
country: United States
facility: Duramed Investigational Site
state: Florida
city: Tampa
country: United States
facility: Duramed Investigational Site
state: Florida
city: West Palm Beach
country: United States
facility: Duramed Investigational Site
state: Florida
city: West Palm Beach
country: United States
facility: Duramed Investigational Site
state: Florida
city: Alpharetta
country: United States
facility: Duramed Investigational Site
state: Georgia
city: Douglasville
country: United States
facility: Duramed Investigational Site
state: Georgia
city: Savannah
country: United States
facility: Duramed Investigational Site
state: Georgia
city: Boise
country: United States
facility: Duramed Investigational Site
state: Idaho
city: Meridian
country: United States
facility: Duramed Investigational Site
state: Idaho
city: Fort Wayne
country: United States
facility: Duramed Investigational Site
state: Indiana
city: Wichita
country: United States
facility: Duramed Investigational Site
state: Kansas
city: Baton Rouge
country: United States
facility: Duramed Investigational Site
state: Louisiana
city: Metairie
country: United States
facility: Duramed Investigational Site
state: Louisiana
city: Shreveport
country: United States
facility: Duramed Investigational Site
state: Louisiana
city: Riverdale
country: United States
facility: Duramed Investigational Site
state: Maryland
city: Kansas City
country: United States
facility: Duramed Investigational Site
state: Missouri
city: Las Vegas
country: United States
facility: Duramed Investigational Site
state: Nevada
city: Las Vegas
country: United States
facility: Duramed Investigational Site
state: Nevada
city: N. Las Vegas
country: United States
facility: Duramed Investigational Site
state: Nevada
city: Lebanon
country: United States
facility: Duramed Investigational Site
state: New Hampshire
city: Cary
country: United States
facility: Duramed Investigational Site
state: North Carolina
city: New Bern
country: United States
facility: Duramed Investigational Site
state: North Carolina
city: Winston-Salem
country: United States
facility: Duramed Investigational Site
state: North Carolina
city: Cleveland
country: United States
facility: Duramed Investigational Site
state: Ohio
city: Mayfield Heights
country: United States
facility: Duramed Investigational Site
state: Ohio
city: Eugene
country: United States
facility: Duramed Investigational Site
state: Oregon
city: Medford
country: United States
facility: Duramed Investigational Site
state: Oregon
city: Pittsburgh
country: United States
facility: Duramed Investigational Site
state: Pennsylvania
city: Charleston
country: United States
facility: Duramed Investigational Site
state: South Carolina
city: Columbia
country: United States
facility: Duramed Investigational Site
state: South Carolina
city: Hilton Head Island
country: United States
facility: Duramed Investigational Site
state: South Carolina
city: Jackson
country: United States
facility: Duramed Investigational Site
state: Tennessee
city: Austin
country: United States
facility: Duramed Investigational Site
state: Texas
city: Dallas
country: United States
facility: Duramed Investigational Site
state: Texas
city: Houston
country: United States
facility: Duramed Investigational Site
state: Texas
city: San Antonio
country: United States
facility: Duramed Investigational Site
state: Texas
city: Salt Lake City
country: United States
facility: Duramed Investigational Site
state: Utah
city: Williston
country: United States
facility: Duramed Investigational Site
state: Vermont
Study officials:
affiliation: Duramed Research
name: Duramed Medical Monitor
role: PRINCIPAL_INVESTIGATOR
References: