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Open-Label Study to Evaluate the Efficacy and Safety of an Extended-Cycle, Low Dose Combination Oral Contraceptive

This study has been completed.

Sponsored by: Duramed Research
Information provided by: Duramed Research
ClinicalTrials.gov Identifier: NCT00196326
  Purpose

This is an open-label, single treatment study. All subjects will receive one year of oral contraceptive therapy with DR-1011. 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
Contraception
Drug: DR-1011
Phase III

MedlinePlus related topics:   Birth Control   

ChemIDplus related topics:   Depogen    Estradiol    Estradiol 3-benzoate    Estradiol acetate    Estradiol cypionate    Estradiol dipropionate    Estradiol valerate    Polyestradiol phosphate    Ethinyl estradiol   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Prevention, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:   A Multicenter, Open-Label Study to Evaluate the Efficacy and Safety of an Extended-Cycle, Low Dose, Combination Oral Contraceptive, Which Utilizes Ethinyl Estradiol During the Seven Day Interval Between Each 84-Day Cycle

Further study details as provided by Duramed Research:

Primary Outcome Measures:
  • Evaluation of pregnancy rates [ Time Frame: Duration of study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Adverse events reported by patients and investigators [ Time Frame: Duration of study ] [ Designated as safety issue: Yes ]

Estimated Enrollment:   2000
Study Start Date:   June 2005
Study Completion Date:   June 2007
Primary Completion Date:   June 2007 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
1: Experimental Drug: DR-1011
1 tablet daily

  Eligibility
Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

Criteria

Inclusion Criteria:

  • Premenopausal
  • Not pregnant or breastfeeding
  • Sexually active at risk of pregnancy

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: NCT00196326

Show 55 study locations  Show 55 Study Locations

Sponsors and Collaborators
Duramed Research

Investigators
Study Chair:     Duramed Protocol Chair     Duramed Research, Inc.    
  More Information

Responsible Party:   Duramed Research, Inc. ( Druamed Protocol Chair )
Study ID Numbers:   DR-PSE-309
First Received:   September 12, 2005
Last Updated:   February 29, 2008
ClinicalTrials.gov Identifier:   NCT00196326
Health Authority:   United States: Food and Drug Administration

Keywords provided by Duramed Research:
pregnancy prevention  
oral contraceptives  

Study placed in the following topic categories:
Estradiol 3-benzoate
Estradiol valerate
Ethinyl Estradiol
Estradiol 17 beta-cypionate
Polyestradiol phosphate
Estradiol

ClinicalTrials.gov processed this record on September 04, 2008




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