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

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

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

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 3-benzoate Ethinyl estradiol Polyestradiol phosphate Depogen Estradiol dipropionate 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

Sponsors and Collaborators

Duramed Research

Investigators

Study Chair:

Duramed Protocol Chair

Duramed Research, Inc.

More Information

Publications:

Kroll R, Reape KZ, Margolis M. The efficacy and safety of a low-dose, 91-day, extended-regimen oral contraceptive with continuous ethinyl estradiol. Contraception. 2010 Jan;81(1):41-8.

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 February 12, 2012