Open-Label Study to Evaluate the Efficacy and Safety of an Extended-Cycle, Low Dose Combination Oral Contraceptive - Full Text View

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 III

MedlinePlus related topics:

Birth Control

ChemIDplus related topics:

Depogen Estradiol Estradiol 3-benzoate Estradiol acetate Estradiol cypionate Estradiol dipropionate Estradiol valerate Polyestradiol phosphate Ethinyl estradiol

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

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

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 ]

Estimated Enrollment:	2000
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
1: Experimental	Drug: DR-1011 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:

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

Responsible Party:	Duramed Research, Inc. ( Druamed Protocol Chair )
Study ID Numbers:	DR-PSE-309
First Received:	September 12, 2005
Last Updated:	February 29, 2008
ClinicalTrials.gov Identifier:	NCT00196326
Health Authority:	United States: Food and Drug Administration

Keywords provided by Duramed Research:

pregnancy prevention

oral contraceptives

Study placed in the following topic categories:

Estradiol 3-benzoate

Estradiol valerate

Ethinyl Estradiol

Estradiol 17 beta-cypionate

Polyestradiol phosphate

Estradiol

ClinicalTrials.gov processed this record on September 04, 2008

Sponsored by:	Duramed Research
Information provided by:	Duramed Research
ClinicalTrials.gov Identifier:	NCT00196326