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Open-Label Study to Evaluate the Safety and Efficacy of a Low-Dose 28-Day Oral Contraceptive

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00362479
First Posted: August 10, 2006
Last Update Posted: August 21, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Teva Pharmaceutical Industries
August 9, 2006
August 10, 2006
August 21, 2013
August 2006
July 2007   (Final data collection date for primary outcome measure)
Evaluation of pregnancy rates [ Time Frame: Duration of study ]
Evaluation of pregnancy rates
Complete list of historical versions of study NCT00362479 on ClinicalTrials.gov Archive Site
Adverse events reported by patients and investigators [ Time Frame: Duration of study ]
Adverse events reported by patients and investigators
Not Provided
Not Provided
 
Open-Label Study to Evaluate the Safety and Efficacy of a Low-Dose 28-Day Oral Contraceptive
A Prospective, Multicenter, Open-Label Study to Evaluate the Safety and Efficacy of the 28-Day Oral Contraceptive DR-1021
This is an open-label, single treatment study. All subjects will receive 6 months of oral contraceptive therapy with DR-1021. Study participants will receive physical and gynecological exams, including Pap smear. During the study, all participants will be required to complete a diary.
The overall study duration for each patient will be approximately 8 months, which includes a screening period of approximately 4 weeks; a treatment period of approximately six months (six,28-day cycles); and a follow-up visit approximately 4 weeks after completion of study drug.
Interventional
Phase 3
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Contraception
Drug: DR-1021
1 tablet daily
Experimental: 1
Intervention: Drug: DR-1021
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1347
July 2007
July 2007   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Female
18 Years to 45 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00362479
DR-DSG-301
No
Not Provided
Not Provided
Duramed Protocol Chair, Duramed Research, Inc.
Duramed Research
Not Provided
Principal Investigator: Duramed Medical Monitor Duramed Research
Teva Pharmaceutical Industries
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP