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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.
Sponsor:
Information provided by:
Duramed Research
ClinicalTrials.gov Identifier:
NCT00196326
First received: September 12, 2005
Last updated: February 4, 2010
Last verified: February 2010
History of Changes
  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 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
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

Resource links provided by NLM:

MedlinePlus related topics: Birth Control
U.S. FDA Resources

Further study details as provided by Duramed Research:

Primary Outcome Measures:
  • Pregnancy Rate (Pearl Index) [ Time Frame: After the onset of treatment and within 14 days after the last combination pill (approx. 1 year of treatment) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Adverse Events Reported by Patients and Investigators [ Time Frame: Up to one year ] [ Designated as safety issue: Yes ]

Enrollment: 2235
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
Experimental: 1
Investigational Drug
 Drug: DR-1011
1 tablet daily
Other Name: levonorgestrel/ethinyl estradiol

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

Publications:

Responsible Party: Druamed Protocol Chair, Duramed Research, Inc.
ClinicalTrials.gov Identifier: NCT00196326     History of Changes
Other Study ID Numbers: DR-PSE-309
Study First Received: September 12, 2005
Results First Received: November 21, 2008
Last Updated: February 4, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Duramed Research:
pregnancy prevention
oral contraceptives

Additional relevant MeSH terms:
Contraceptive Agents
Levonorgestrel
Contraceptives, Oral
Estradiol
Ethinyl Estradiol
Reproductive Control Agents
Physiological Effects of Drugs
 Pharmacologic Actions
Therapeutic Uses
Contraceptive Agents, Female
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Contraceptives, Oral, Synthetic

ClinicalTrials.gov processed this record on May 23, 2013