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

Sponsor:	Duramed Research
Information provided by:	Duramed Research
ClinicalTrials.gov Identifier:	NCT00362479

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 III

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 Prospective, Multicenter, Open-Label Study to Evaluate the Safety and Efficacy of the 28-Day Oral Contraceptive DR-1021

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:

Evaluation of pregnancy rates [ Time Frame: Duration of study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Adverse events reported by patients and investigators [ Time Frame: Duration of study ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:	18 Years to 45 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: NCT00362479

Show 85 Study Locations

Sponsors and Collaborators

Duramed Research

Investigators

Principal Investigator:

Duramed Medical Monitor

Duramed Research

More Information

No publications provided

Responsible Party:	Duramed Protocol Chair, Duramed Research, Inc.
ClinicalTrials.gov Identifier:	NCT00362479 History of Changes
Other Study ID Numbers:	DR-DSG-301
Study First Received:	August 9, 2006
Last Updated:	January 8, 2010
Health Authority:	United States: Food and Drug Administration

Keywords provided by Duramed Research:

pregnancy prevention
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 February 09, 2012