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

This study has been completed.
Sponsor:
Information provided by:
Teva Pharmaceutical Industries
ClinicalTrials.gov Identifier:
NCT00362479
First received: August 9, 2006
Last updated: August 20, 2013
Last verified: August 2013

August 9, 2006
August 20, 2013
August 2006
July 2007   (final data collection date for primary outcome measure)
Evaluation of pregnancy rates [ Time Frame: Duration of study ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: Yes ]
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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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
Female
18 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00362479
DR-DSG-301
No
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