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

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ClinicalTrials.gov Identifier: NCT00362479
Recruitment Status : Completed
First Posted : August 10, 2006
Last Update Posted : August 21, 2013
Sponsor:
Information provided by:
Teva Pharmaceutical Industries

Brief Summary:
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 or disease Intervention/treatment Phase
Contraception Drug: DR-1021 Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1347 participants
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
Study Start Date : August 2006
Primary Completion Date : July 2007
Study Completion Date : July 2007

Arm Intervention/treatment
Experimental: 1 Drug: DR-1021
1 tablet daily



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

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


Information from the National Library of Medicine

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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

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

Responsible Party: Duramed Protocol Chair, Duramed Research, Inc.
ClinicalTrials.gov Identifier: NCT00362479     History of Changes
Other Study ID Numbers: DR-DSG-301
First Posted: August 10, 2006    Key Record Dates
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