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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
  Purpose
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.

Condition Intervention Phase
Contraception Drug: DR-1021 Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Prospective, Multicenter, Open-Label Study to Evaluate the Safety and Efficacy of the 28-Day Oral Contraceptive DR-1021

Further study details as provided by Teva Pharmaceutical Industries:

Primary Outcome Measures:
  • Evaluation of pregnancy rates [ Time Frame: Duration of study ]

Secondary Outcome Measures:
  • Adverse events reported by patients and investigators [ Time Frame: Duration of study ]

Enrollment: 1347
Study Start Date: August 2006
Study Completion Date: July 2007
Primary Completion Date: July 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: DR-1021
1 tablet daily

Detailed Description:
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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00362479


  Show 85 Study Locations
Sponsors and Collaborators
Duramed Research
Investigators
Principal Investigator: Duramed Medical Monitor Duramed Research
  More Information

Responsible Party: Duramed Protocol Chair, Duramed Research, Inc.
ClinicalTrials.gov Identifier: NCT00362479     History of Changes
Other Study ID Numbers: DR-DSG-301
First Submitted: August 9, 2006
First Posted: August 10, 2006
Last Update Posted: August 21, 2013
Last Verified: August 2013

Keywords provided by Teva Pharmaceutical Industries:
pregnancy prevention
oral contraceptives

Additional relevant MeSH terms:
Contraceptive Agents
Contraceptives, Oral
Reproductive Control Agents
Physiological Effects of Drugs
Contraceptive Agents, Female