Open-label Study to Evaluate the Efficacy and Safety of an Extended-cycle, Low Dose Combination Oral Contraceptive
This study has been completed.
Sponsor:
Duramed Research
Information provided by:
Duramed Research
ClinicalTrials.gov Identifier:
NCT00196326
First received: September 12, 2005
Last updated: February 4, 2010
Last verified: February 2010
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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
Drug Information available for:
Estradiol
Estradiol cypionate
Levonorgestrel
Estradiol valerate
Estradiol acetate
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
Show 55 Study Locations
Sponsors and Collaborators
Duramed Research
Investigators
Study Chair: | Duramed Protocol Chair | Duramed Research, Inc. |
More Information
Publications:
Keywords provided by Duramed Research:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on October 16, 2012
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 October 16, 2012