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

A Phase 3 study testing DR-1021 in people with Contraception, run by Duramed Research at 85 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

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. Read more about this study

Who is it for?: Ages 18 to 45 years, women onlyHealthy volunteers can take part
Conditions the study is for: Contraception
What is being tested?: DR-1021
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1,347 participants
Where: 85 sitesUnited States
Study dates: Aug 2006to Jul 2007
Phase: Phase 3
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 45 years
Women only
Healthy volunteers accepted
Adult

Who may be able to join

Premenopausal
Not pregnant or breastfeeding
Sexually active at risk of pregnancy

Who cannot join

Any contraindication to the use of oral contraceptives
Pregnancy within the last 3 months
Smoking > 10 cigarettes per day

Trial locations and contacts

85 sites in 1 country.

City, postcode or hospital

85 sites in 1 country

United States85 sites

Duramed Investigational Site
Albuquerque, New Mexico, 87102
Duramed Investigational Site
Arlington, Virginia, 22203
Duramed Investigational Site
Atlanta, Georgia, 30328
Duramed Investigational Site
Atlanta, Georgia, 30342
Duramed Investigational Site
Austin, Texas, 78759
Duramed Investigational Site
Aventura, Florida, 33180
Duramed Investigational Site
Boise, Idaho, 83704
Duramed Investigational Site
Boynton Beach, Florida, 33437
Duramed Investigational Site
Bristol, Tennessee, 37620
Duramed Investigational Site
Brooksville, Florida, 33613
Duramed Investigational Site
Carmichael, California, 95608
Duramed Investigational Site
Charlotte, North Carolina, 28211
Duramed Investigational Site
Chattanooga, Tennessee, 37404
Duramed Investigational Site
Chicago, Illinois, 60611
Duramed Investigational Site
Chicago, Illinois, 60612
Duramed Investigational Site
Clarksville, Tennessee, 37043
Duramed Investigational Site
Clearwater, Florida, 33761
Duramed Investigational Site
Colorado Springs, Colorado, 80909
Duramed Investigational Site
Columbus, Ohio, 43210
Duramed Investigational Site
Columbus, Ohio, 43213
Duramed Investigational Site
Coral Gables, Florida, 33134
Duramed Investigational Site
Cranston, Rhode Island, 02920
Duramed Investigational Site
Dallas, Texas, 75234
Duramed Investigational Site
Decatur, Georgia, 30034
Duramed Investigational Site
Fort Meyers, Florida, 33918
Duramed Investigational Site
Germantown, Tennessee, 38138
Duramed Investigational Site
Greer, South Carolina, 29651
Duramed Investigational Site
Houston, Texas, 77030
Duramed Investigational Site
Huntsville, Alabama, 35801
Duramed Investigational Site
Irvine, California, 92618
Duramed Investigational Site
Johnson City, New York, 13790
Duramed Investigational Site
Kansas City, Missouri, 64108
Duramed Investigational Site
Knoxville, Tennessee, 37920
Duramed Investigational Site
Lakewood, Colorado, 80228
Duramed Investigational Site
Lakewood, Washington, 98499
Duramed Investigational Site
Las Vegas, Nevada, 89146
Duramed Investigational Site
Leesburg, Florida, 34748
Duramed Investigational Site
Lexington, Kentucky, 40509
Duramed Investigational Site
Lincoln, Nebraska, 68510
Duramed Investigational Site
Longwood, Florida, 32779
Duramed Investigational Site
Louisville, Kentucky, 40291
Duramed Investigational Site
Magna, Utah, 84044
Duramed Investigational Site
Medford, Oregon, 97504
Duramed Investigational Site
Miami, Florida, 33173
Duramed Investigational Site
Mobile, Alabama, 36608
Duramed Investigational Site
Moorestown, New Jersey, 08057
Duramed Investigational Site
Mount Sterling, Kentucky, 40353
Duramed Investigational Site
Mt. Pleasant, South Carolina, 29464
Duramed Investigational Site
Nashville, Tennessee, 37203
Duramed Investigational Site
New Brunswick, New Jersey, 08901
Duramed Investigational Site
Newport News, Virginia, 23602
Duramed Investigational Site
Norfolk, Virginia, 23507
Duramed Investigational Site
Oklahoma City, Oklahoma, 73112
Duramed Investigational Site
Peoria, Illinois, 61602
Duramed Investigational Site
Philadelphia, Pennsylvania, 19114
Duramed Investigational Site
Phoenix, Arizona, 85015
Duramed Investigational Site
Phoenix, Arizona, 85031
Duramed Investigational Site
Pinellas Park, Florida, 33781
Duramed Investigational Site
Pleasant Grove, Utah, 84062
Duramed Investigational Site
Raleigh, North Carolina, 27612
Duramed Investigational Site
Reading, Pennsylvania, 19606
Duramed Investigational Site
Richmond, Virginia, 23233
Duramed Investigational Site
Rochester, New York, 14609
Duramed Investigational Site
Roswell, Georgia, 30075
Duramed Investigational Site
Salt Lake City, Utah, 84124
Duramed Investigational Site
San Antonio, Texas, 78229
Duramed Investigational Site
San Diego, California, 92108
Duramed Investigational Site
San Diego, California, 92123
Duramed Investigational Site
San Ramon, California, 94583
Duramed Investigational Site
Sandy City, Utah, 84070
Duramed Investigational Site
Sarasota, Florida, 34239
Duramed Investigational Site
Seattle, Washington, 98105
Duramed Investigational Site
Shawnee Mission, Kansas, 66216
Duramed Investigational Site
Spokane, Washington, 99207
Duramed Investigational Site
St. Petersburg, Florida, 33702
Duramed Investigational Site
St. Petersburg, Florida, 33709
Duramed Investigational Site
Tacoma, Washington, 98405
Duramed Investigational Site
Tampa, Florida, 33613
Duramed Investigational Site
Topeka, Kansas, 66614
Duramed Investigational Site
Waco, Texas, 76712
Duramed Investigational Site
Washington D.C., District of Columbia, 20006
Duramed Investigational Site
West Palm Beach, Florida, 33409
Duramed Investigational Site
Wilmington, Delaware, 19805
Duramed Investigational Site
Wilmington, North Carolina, 28412
Duramed Investigational Site
Winston-Salem, North Carolina, 27103

Other trials in United States

About this study

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

Read the 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.

Conditions: Contraception
Being tested: DR-1021
Keywords: pregnancy prevention, oral contraceptives

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

DR-1021Drug
1 tablet daily

Study groups in NCT00362479
Study group	Role	What they receive
1	Experimental	Not described Receives: Drug: DR-1021

What is being measured

The primary outcome is the main question the study is designed to answer.

Evaluation of pregnancy rates
Measured: Duration of study

Secondary outcomes (1)

Adverse events reported by patients and investigators
Measured: Duration of study

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2006Jul 2007

First posted10 Aug 2006 (estimated)
Study startAug 2006
Primary completionJul 2007
Study completionJul 2007

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for ContraceptionStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Prevention
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 1,347 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00362479
Sponsor's protocol ID: DR-DSG-301
Status last verified: Aug 2013
First submitted: 9 Aug 2006
Last updated: 21 Aug 2013
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
Impact of Gender-Transformative Interventions on Contraceptive Use and Reproductive Autonomy in Somalia
Contraceptive Behavior, Social Norms
Recruiting
Impact of Self-Care Family Planning Services on Health and Development in South Sudan (Family Planning Impact Lab)
Contraceptive Behavior, Self Administration
Not yet recruitingPhase 3
Evaluation of the Contraceptive Efficacy and Safety of a New Concentration of an Antiandrogenic Progestogen Combined With a Reduced-Dose Estrogen (LUNA)
Contraception
Recruiting
Prospective Multi-Center Trial for FemBloc Permanent Birth Control
Contraception
RecruitingObservational study
Primitive Immunodeficiency, Intrauterine Devices and Menstrual Hygiene Products
Primary Immune Deficiency Diseases

All Contraception trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Prospective, Multicenter, Open-Label Study to Evaluate the Safety and Efficacy of the 28-Day Oral Contraceptive DR-1021
ClinicalTrials.gov ID: NCT00362479
Acronym / sponsor ID: DR-DSG-301
Conditions: Contraception
Keywords: pregnancy prevention, oral contraceptives
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,347 participants (actual)
Lead sponsor: Duramed ResearchIndustry (pharma, biotech, devices)
Study start: Aug 2006
Primary completion: Jul 2007 (actual)
Study completion: Jul 2007 (actual)
First posted: 10 Aug 2006 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
1	Experimental	Drug: DR-1021

Who may qualify

Ages: 18 to 45 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (3 listed)

Premenopausal
Not pregnant or breastfeeding
Sexually active at risk of pregnancy

Key exclusion criteria (3 listed)

Any contraindication to the use of oral contraceptives
Pregnancy within the last 3 months
Smoking > 10 cigarettes per day

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
DR-10211 tablet daily	Drug	1

Primary outcome

Evaluation of pregnancy rates
Time frame: Duration of study

1 secondary outcome

Adverse events reported by patients and investigators
Time frame: Duration of study

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2013.

Related trials for Contraception

Not yet recruiting
Impact of Gender-Transformative Interventions on Contraceptive Use and Reproductive Autonomy in Somalia
Contraceptive Behavior, Social Norms
Recruiting
Impact of Self-Care Family Planning Services on Health and Development in South Sudan (Family Planning Impact Lab)
Contraceptive Behavior, Self Administration
Not yet recruitingPhase 3
Evaluation of the Contraceptive Efficacy and Safety of a New Concentration of an Antiandrogenic Progestogen Combined With a Reduced-Dose Estrogen (LUNA)
Contraception
Recruiting
Prospective Multi-Center Trial for FemBloc Permanent Birth Control
Contraception
RecruitingObservational study
Primitive Immunodeficiency, Intrauterine Devices and Menstrual Hygiene Products
Primary Immune Deficiency Diseases

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Duramed Medical Monitor principal investigator

Duramed Research

85 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing DR-1021 in people with Contraception, run by Duramed Research at 85 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 85 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Evaluation of pregnancy rates (time frame: Duration of study). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00362479.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2013.