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

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

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

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