Text Size

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

This study has been completed.
Sponsor:
Information provided by:
Duramed Research
ClinicalTrials.gov Identifier:
NCT00394771
First received: October 30, 2006
Last updated: June 8, 2011
Last verified: June 2011
History of Changes
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
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
Study Completion Date: March 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: DR-1031a
1 tablet daily
Experimental: 2 Drug: DR-1031b
1 tablet daily
Experimental: 3 Drug: DR-1031c
1 tablet daily
Active Comparator: 4 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
Sponsors and Collaborators
Duramed Research
Investigators
Principal Investigator: Duramed Medical Monitor Duramed Research
  More Information

No publications provided

Responsible Party: Duramed Research, Duramed Research, Inc
ClinicalTrials.gov Identifier: NCT00394771     History of Changes
Other Study ID Numbers: DR-ASC-201
Study First Received: October 30, 2006
Last Updated: June 8, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Duramed Research:
oral contraceptives
breakthrough bleeding
spotting

Additional relevant MeSH terms:
Hemorrhage
Metrorrhagia
Pathologic Processes
Uterine Hemorrhage
Uterine Diseases
Genital Diseases, Female
Contraceptive Agents
Ethinyl estradiol, levonorgestrel drug combination
 Contraceptives, Oral
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Contraceptive Agents, Female
Contraceptives, Oral, Combined

ClinicalTrials.gov processed this record on June 17, 2013