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A Study to Evaluate the Efficacy and Safety of DR-103 for the Prevention of Pregnancy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Teva Pharmaceutical Industries ( Teva Women's Health )
ClinicalTrials.gov Identifier:
NCT00996580
First received: October 15, 2009
Last updated: June 21, 2012
Last verified: June 2012
History of Changes
  Purpose

This is an open-label, single-treatment study. All subjects will receive 12 months of oral contraceptive therapy with DR-103. 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
Pregnancy Prevention
 Drug: DR-103
 Phase 3

Study Type: Interventional
Study Design: 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 a Combination Oral Contraceptive Regimen (DR-103) for the Prevention of Pregnancy in Women

Resource links provided by NLM:

MedlinePlus related topics: Women's Health
U.S. FDA Resources

Further study details as provided by Teva Pharmaceutical Industries:

Primary Outcome Measures:
  • Pregnancy rate (Pearl Index) from the onset of treatment to within 14 days of last dose of investigational drug treatment [ Time Frame: 13 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Adverse events reported by subjects and investigators over the 13 month study treatment period [ Time Frame: 13 months ] [ Designated as safety issue: Yes ]

Enrollment: 3701
Study Start Date: October 2009
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: DR-103

Levonorgestrel/ethinyl estradiol 0.15/0.02 mg for 42 days then Levonorgestrel/ethinyl estradiol 0.15/0.025 mg for 21 days then Levonorgestrel/ethinyl estradiol 0.15/0.03 mg for 21 days then Ethinyl estradiol 0.01 mg for 7 days

Take 1 tablet daily

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Sexually active at risk for pregnancy
  • Agreement to use study OC therapy as their only method of birth control during the study
  • history of regular spontaneous menstrual cycles or withdrawal bleeding episodes
  • Others as dictated by FDA-approved protocol

Exclusion Criteria:

  • Any contraindication to the use of oral contraceptives
  • Pregnancy or plans to become pregnant in the next 14 months
  • Smoker and age ≥ 35 years
  • Others as dictated by FDA-approved protocol
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00996580

  Show 94 Study Locations
Sponsors and Collaborators
Teva Women's Health
  More Information

No publications provided

Responsible Party: Teva Pharmaceutical Industries ( Teva Women's Health )
ClinicalTrials.gov Identifier: NCT00996580     History of Changes
Other Study ID Numbers: DR-103-301
Study First Received: October 15, 2009
Last Updated: June 21, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Teva Pharmaceutical Industries:
Contraception
Oral contraceptives

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

ClinicalTrials.gov processed this record on May 19, 2013