ContraceptionPhase 3NCT00196326
Open-label Study to Evaluate the Efficacy and Safety of an Extended-cycle, Low Dose Combination Oral Contraceptive
A Phase 3 study testing DR-1011 in people with Contraception, run by Duramed Research at 55 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Contraception
- What is being tested?
- DR-1011
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,235 participants
- Where
- 55 sitesUnited States
- Study dates
- Jun 2005to Jun 2007
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 40 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
55 sites in 1 country.
55 sites in 1 country
United States55 sites
Duramed Investigational Site
Boise, Idaho, 83704
Duramed Investigational Site
Charlotte, North Carolina, 28222
Duramed Investigational Site
Chicago, Illinois, 60611
Duramed Investigational Site
Colorado Springs, Colorado, 80907
Duramed Investigational Site
Colorado Springs, Colorado, 80909
Duramed Investigational Site
Columbus, Ohio, 43205
Duramed Investigational Site
Columbus, Ohio, 43213
Duramed Investigational Site
Coral Cables, Florida, 33134
Duramed Investigational Site
Dallas, Texas, 75390
Duramed Investigational Site
Decatur, Georgia, 30034
Duramed Investigational Site
Denver, Colorado, 80202
Duramed Investigational Site
Douglasville, Georgia, 30134
Duramed Investigational Site
Hollywood, Florida, 33024
Duramed Investigational Site
Houston, Texas, 77030
Duramed Investigational Site
Huntsville, Alabama, 35801
Duramed Investigational Site
Jacksonville, Florida, 32216
Duramed Investigational Site
Kansas City, Missouri, 64106
Duramed Investigational Site
Lakewood, Washington, 98499
Duramed Investigational Site
Lawrenceville, New Jersey, 08648
Duramed Investigational Site
Leesburg, Florida, 34748
Duramed Investigational Site
Louisville, Kentucky, 40291
Duramed Investigational Site
Medford, Oregon, 97504
Duramed Investigational Site
Miami, Florida, 33143
Duramed Investigational Site
Moorestown, New Jersey, 08057
Duramed Investigational Site
New Brunswick, New Jersey, 08901
Duramed Investigational Site
New London, Connecticut, 06320
Duramed Investigational Site
Newport News, Virginia, 23602
Duramed Investigational Site
Norfolk, Virginia, 23507
Duramed Investigational Site
Oklahoma City, Oklahoma, 73112
Duramed Investigational Site
Palm Springs, Florida, 33437
Duramed Investigational Site
Philadelphia, Pennsylvania, 19114
Duramed Investigational Site
Phoenix, Arizona, 85013
Duramed Investigational Site
Phoenix, Arizona, 85031
Duramed Investigational Site
Phoenix, Arizona, 85032
Duramed Investigational Site
Pittsburgh, Pennsylvania, 15206
Duramed Investigational Site
Pittsburgh, Pennsylvania, 15213
Duramed Investigational Site
Richmond, Virginia, 23226
Duramed Investigational Site
Rochester, New York, 14609
Duramed Investigational Site
Salt Lake City, Utah, 84124
Duramed Investigational Site
San Antonio, Texas, 78229
Duramed Investigational Site
San Diego, California, 92103
Duramed Investigational Site
San Diego, California, 92108
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 Louis, Missouri, 63110
Duramed Investigational Site
Tacoma, Washington, 98405
Duramed Investigational Site
Tampa, Florida, 33607
Duramed Investigational Site
Topeka, Kansas, 66614
Duramed Investigational Site
Tucson, Arizona, 85712
Duramed Investigational Site
Waco, Texas, 76712
Duramed Investigational Site
Willow Grove, Pennsylvania, 19090
Duramed Investigational Site
Wilmington, North Carolina, 28412
Duramed Investigational Site
Winston-Salem, North Carolina, 27103
About this 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
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.
- Conditions
- Contraception
- Being tested
- DR-1011
- 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-1011Drug
Also called levonorgestrel/ethinyl estradiol
Eighty-four orange, embossed tablets, each containing 100 μg levonorgestrel (LNG) / 20 μg ethinyl estradiol (EE) and 7 yellow, embossed tablets, each containing 10 μg of EE. One combination tablet was to be taken each day for 84 days followed by 7 days of EE tablets in 91-day cycles repeated consecutively for approximately one year (four 91-day cycles).
| Study group | Role | What they receive |
|---|---|---|
| DR-1011 | Experimental | Participants were instructed to take, by mouth, one tablet daily for four 91-day cycles. Receives: Drug: DR-1011 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Annualized Pregnancy Rate (Pearl Index) For 91-Day Cycles by Cohort Using up to 14 Days Post-Last Combination Dose When Defining "On Drug" Pregnancy
Pearl Index= ((100)*(number of pregnancies)*(4 cycles/year))/number of 91-day cycles completed.
The pregnancy rate included "on-drug" pregnancies, defined as those pregnancies for which the date of conception was on or after the date of first dose of study medication, but no more than 14 days after the date of last combination dose of study medication.
Pregnancy was defined as a positive pregnancy test verified by the study staff. The conception date was based on the ultrasound date. A pregnancy was not considered 'on drug' if conception clearly occurred prior to first dose of study medication, or more than 14 days after the date of last combination dose of study medication.
Three denominators are reported;
- excluding cycles where other birth control methods (BCMs) was used
- all complete cycles
- compliant-use (i.e. subject did not skip two or more consecutive pills or had a pattern of substantial non-compliance, or used a prohibited concomitant medication)
Measured: up to one year
Annualized Pregnancy Rate (Pearl Index) For 91-Day Cycles by Cohort Using up to 7 Days Post-Last Combination Dose When Defining "On Drug" Pregnancy
Pearl Index= ((100)*(number of pregnancies)*(4 cycles/year))/number of 91-day cycles completed.
The pregnancy rate included "on-drug" pregnancies, defined as those pregnancies for which the date of conception was on or after the date of first dose of study medication, but no more than 7 days after the date of last combination dose of study medication.
Pregnancy was defined as a positive pregnancy test verified by the study staff. The conception date was based on the ultrasound date. A pregnancy was not considered 'on drug' if conception clearly occurred prior to first dose of study medication, or more than 7 days after the date of last combination dose of study medication.
Three denominators are reported;
- excluding cycles where other birth control methods (BCMs) was used
- all complete cycles
- compliant-use (i.e. subject did not skip two or more consecutive pills or had a pattern of substantial non-compliance, or used a prohibited concomitant medication)
Measured: up to one year
Secondary outcomes (1)
Participants With Treatment-Emergent Adverse Events
Safety was assessed by summarizing adverse events recorded in the patient's daily diary and reported by subjects at each study visit, and by summarizing results of examination, vital signs and clinical laboratory values.
Measured: Day 1 up to one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startJun 2005
- Primary completionJun 2007
- Study completionJun 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2,235 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duramed Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Duramed Protocol Chair, Study chair, Duramed Research, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00196326
- Sponsor's protocol ID
- DR-PSE-309
- Status last verified
- Sep 2016
- First submitted
- 12 Sep 2005
- Last updated
- 16 Nov 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
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. doi: 10.1016/j.contraception.2009.07.003.
PubMed 20004272
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00196326
- Acronym / sponsor ID
- DR-PSE-309
- Conditions
- Contraception
- Keywords
- pregnancy prevention, oral contraceptives
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,235 participants (actual)
- Lead sponsor
- Duramed ResearchIndustry (pharma, biotech, devices)
- Study start
- Jun 2005
- Primary completion
- Jun 2007 (actual)
- Study completion
- Jun 2007 (actual)
- First posted
- 20 Sep 2005 (estimated)
- Results
- Posted 15 Apr 2009
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DR-1011 | Experimental | Drug: DR-1011Participants were instructed to take, by mouth, one tablet daily for four 91-day cycles. |
Who may qualify
- Ages
- 18 to 40 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-1011Also: levonorgestrel/ethinyl estradiolEighty-four orange, embossed tablets, each containing 100 μg levonorgestrel (LNG) / 20 μg ethinyl estradiol (EE) and 7 yellow, embossed tablets, each containing 10 μg of EE. One combination tablet was to be taken each day for 84 days followed by 7 days of EE tablets in 91-day cycles repeated consecutively for approximately one year (four 91-day cycles). | Drug | DR-1011 |
Primary outcome
Annualized Pregnancy Rate (Pearl Index) For 91-Day Cycles by Cohort Using up to 14 Days Post-Last Combination Dose When Defining "On Drug" Pregnancy
Time frame: up to one year
Pearl Index= ((100)*(number of pregnancies)*(4 cycles/year))/number of 91-day cycles completed. The pregnancy rate included "on-drug" pregnancies, defined as those pregnancies for which the date of conception was on or after the date of first dose of study medication, but no more than 14 days after the date of last combination dose of study medication. Pregnancy was defined as a positive pregnancy test verified by the study staff. The conception date was based on the ultrasound date. A pregnancy was not considered 'on drug' if conception clearly occurred prior to first dose of study medication, or more than 14 days after the date of last combination dose of study medication. Three denominators are reported; * excluding cycles where other birth control methods (BCMs) was used * all complete cycles * compliant-use (i.e. subject did not skip two or more consecutive pills or had a pattern of substantial non-compliance, or used a prohibited concomitant medication)
Annualized Pregnancy Rate (Pearl Index) For 91-Day Cycles by Cohort Using up to 7 Days Post-Last Combination Dose When Defining "On Drug" Pregnancy
Time frame: up to one year
Pearl Index= ((100)*(number of pregnancies)*(4 cycles/year))/number of 91-day cycles completed. The pregnancy rate included "on-drug" pregnancies, defined as those pregnancies for which the date of conception was on or after the date of first dose of study medication, but no more than 7 days after the date of last combination dose of study medication. Pregnancy was defined as a positive pregnancy test verified by the study staff. The conception date was based on the ultrasound date. A pregnancy was not considered 'on drug' if conception clearly occurred prior to first dose of study medication, or more than 7 days after the date of last combination dose of study medication. Three denominators are reported; * excluding cycles where other birth control methods (BCMs) was used * all complete cycles * compliant-use (i.e. subject did not skip two or more consecutive pills or had a pattern of substantial non-compliance, or used a prohibited concomitant medication)
1 secondary outcome
Participants With Treatment-Emergent Adverse Events
Time frame: Day 1 up to one year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 20004272Kroll 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. doi: 10.1016/j.contraception.2009.07.003.
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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 Protocol Chair study chair
Duramed Research, Inc.
55 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-1011 in people with Contraception, run by Duramed Research at 55 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 16 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 55 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?
Yes. Results are posted in the registry (first posted 15 Apr 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Annualized Pregnancy Rate (Pearl Index) For 91-Day Cycles by Cohort Using up to 14 Days Post-Last Combination Dose When Defining "On Drug" Pregnancy (time frame: up to one year). The study lists 2 primary outcomes in all. 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 NCT00196326, which also lists 1 linked publication.
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 16 Nov 2016.