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

This study is ongoing, but not recruiting participants.

Sponsored by: Duramed Research
Information provided by: Duramed Research
ClinicalTrials.gov Identifier: NCT00394771
  Purpose

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


Condition Intervention Phase
Breakthrough Bleeding
Drug: DR-1031a
Drug: DR-1031b
Drug: DR-1031c
Drug: Seasonale
Phase II

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Prevention, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by Duramed Research:

Primary Outcome Measures:
  • Total number of bleeding and/or spotting days during active treatment period. [ Time Frame: Each cycle ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Total number of bleeding days during active treatment period [ Time Frame: Each cycle ] [ Designated as safety issue: Yes ]
  • Timing and severity of bleeding [ Time Frame: Each cycle ] [ Designated as safety issue: Yes ]
  • Onset,duration,severity of scheduled withdrawal bleeding [ Time Frame: Each cycle ] [ Designated as safety issue: Yes ]
  • Number of subjects reporting hormone-related symptoms [ Time Frame: Each cycle ] [ Designated as safety issue: Yes ]
  • Adverse events reported by subjects and investigators [ Time Frame: Active treatment period ] [ Designated as safety issue: Yes ]

Estimated Enrollment:   400
Study Start Date:   October 2006
Estimated Study Completion Date:   February 2008
Estimated Primary Completion Date:   February 2008 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
1: Experimental Drug: DR-1031a
1 tablet daily
2: Experimental Drug: DR-1031b
1 tablet daily
3: Experimental Drug: DR-1031c
1 tablet daily
4: Active Comparator Drug: Seasonale
1 tablet daily

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
Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00394771

Show 50 study locations  Show 50 Study Locations

Sponsors and Collaborators
Duramed Research

Investigators
Principal Investigator:     Duramed Medical Monitor     Duramed Research    
  More Information

Responsible Party:   Duramed Research, Inc ( Duramed Research )
Study ID Numbers:   DR-ASC-201
First Received:   October 30, 2006
Last Updated:   February 18, 2008
ClinicalTrials.gov Identifier:   NCT00394771
Health Authority:   United States: Food and Drug Administration

Keywords provided by Duramed Research:
oral contraceptives  
breakthrough bleeding  
spotting  

Study placed in the following topic categories:
Genital Diseases, Female
Uterine Hemorrhage
Metrorrhagia
Uterine Diseases
Hemorrhage

Additional relevant MeSH terms:
Pathologic Processes

ClinicalTrials.gov processed this record on September 05, 2008




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