DysmenorrheaPhase 3NCT00196365
A Study to Evaluate the Efficacy of Seasonique for the Treatment of Cyclic Pelvic Pain
A Phase 3 study testing levonorgestrel/EE 0.15/0.03 and EE 0.01 mg tablets in people with Dysmenorrhea, run by Duramed Research at 18 sites in United States.
Trial summary
This study is being conducted to evaluate the effects of treatment with Seasonique an extended-regimen oral contraceptive that utilizes low dose ethinyl estradiol during the typical hormone-free interval. Patients will receive 26 weeks of treatment. The overall study duration will be approximately 9 months. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Dysmenorrhea
- What is being tested?
- levonorgestrel/EE 0.15/0.03 and EE 0.01 mg tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 97 participants
- Where
- 18 sitesUnited States
- Study dates
- Jan 2005to 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 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Moderate to severe menstrual-related pain
- Regular spontaneous menstrual cycles
Who cannot join
- Any contraindication to the use of oral contraceptives
- Treatment with an oral contraceptive in the last 3 months
- Previous treatment failure with an extended oral contraceptive regimen
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
United States18 sites
Duramed Investigational Site
Charlotte, North Carolina, 28222
Duramed Investigational Site
Columbus, Ohio, 43205
Duramed Investigational Site
Columbus, Ohio, 43213
Duramed Investigational Site
Decatur, Georgia, 30034
Duramed Investigational Site
Denver, Colorado, 80202
Duramed Investigational Site
Huntsville, Alabama, 35801
Duramed Investigational Site
Medford, Oregon, 97504
Duramed Investigational Site
Memphis, Tennessee, 38120
Duramed Investigational Site
Moorestown, New Jersey, 08057
Duramed Investigational Site
Newport News, Virginia, 23602
Duramed Investigational Site
Norfolk, Virginia, 23507
Duramed Investigational Site
Philadelphia, Pennsylvania, 19114
Duramed Investigational Site
Phoenix, Arizona, 85032
Duramed Investigational Site
Salt Lake City, Utah, 84124
Duramed Investigational Site
San Diego, California, 92108
Duramed Investigational Site
Spokane, Washington, 99207
Duramed Investigational Site
Tacoma, Washington, 98405
Duramed Investigational Site
Tampa, Florida, 33607
About this study
Official title: A Study to Compare the Efficacy of an Extended-cycle Oral Contraceptive, Seasonique Which Utilizes Ethinyl Estradiol During the Usual Hormone-free Interval Compared to Conventional Oral Contraceptive Therapy for Cyclic Pelvic Pain
This study is being conducted to evaluate the effects of treatment with Seasonique an extended-regimen oral contraceptive that utilizes low dose ethinyl estradiol during the typical hormone-free interval. Patients will receive 26 weeks of treatment. The overall study duration will be approximately 9 months. Patients will be required to record menstrual pain in a daily diary.
- Conditions
- Dysmenorrhea
- Being tested
- levonorgestrel/EE 0.15/0.03 and EE 0.01 mg tablets, levonorgestrel/EE 0.15/0.03 mg tablets and placebo
- Keywords
- cyclic pelvic pain, dysmenorrhea
- Medical subject headings
- Dysmenorrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
levonorgestrel/EE 0.15/0.03 and EE 0.01 mg tabletsDrug
Also called Seasonique
1 tablet daily
levonorgestrel/EE 0.15/0.03 mg tablets and placeboDrug
Also called Portia
1 tablet daily
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: levonorgestrel/EE 0.15/0.03 and EE 0.01 mg tablets |
| 2 | Active comparator | Not described Receives: Drug: levonorgestrel/EE 0.15/0.03 mg tablets and placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in the clinical assessment of dysmenorrhea
Measured: Baseline to Week 4,8,12,24, and 26 or early discontinuation
Secondary outcomes (3)
Change from baseline in clinical assessment of dysmenorrhea (assessment of 4 additional symptoms)
Measured: Baseline to Weeks 4, 8, 12, 24 and 26 or early discontinuation
Incidence of menstrual bleeding and/or spotting
Measured: Duration of study
Analgesic use
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.
- First posted20 Sep 2005 (estimated)
- Study startJan 2005
- 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 DysmenorrheaStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 97 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
- NCT00196365
- Sponsor's protocol ID
- DR-PSE-305
- Status last verified
- May 2014
- First submitted
- 12 Sep 2005
- Last updated
- 12 May 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Compare the Efficacy of an Extended-cycle Oral Contraceptive, Seasonique Which Utilizes Ethinyl Estradiol During the Usual Hormone-free Interval Compared to Conventional Oral Contraceptive Therapy for Cyclic Pelvic Pain
- ClinicalTrials.gov ID
- NCT00196365
- Acronym / sponsor ID
- DR-PSE-305
- Conditions
- Dysmenorrhea
- Keywords
- cyclic pelvic pain, dysmenorrhea
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- Duramed ResearchIndustry (pharma, biotech, devices)
- Study start
- Jan 2005
- Primary completion
- Jul 2007 (actual)
- Study completion
- Jul 2007 (actual)
- First posted
- 20 Sep 2005 (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.
This study is being conducted to evaluate the effects of treatment with Seasonique an extended-regimen oral contraceptive that utilizes low dose ethinyl estradiol during the typical hormone-free interval. Patients will receive 26 weeks of treatment. The overall study duration will be approximately 9 months. Patients will be required to record menstrual pain in a daily diary.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: levonorgestrel/EE 0.15/0.03 and EE 0.01 mg tablets |
| 2 | Active comparator | Drug: levonorgestrel/EE 0.15/0.03 mg tablets and placebo |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Moderate to severe menstrual-related pain
- Regular spontaneous menstrual cycles
Key exclusion criteria (3 listed)
- Any contraindication to the use of oral contraceptives
- Treatment with an oral contraceptive in the last 3 months
- Previous treatment failure with an extended oral contraceptive regimen
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 |
|---|---|---|
| levonorgestrel/EE 0.15/0.03 and EE 0.01 mg tabletsAlso: Seasonique1 tablet daily | Drug | 1 |
| levonorgestrel/EE 0.15/0.03 mg tablets and placeboAlso: Portia1 tablet daily | Drug | 2 |
Primary outcome
Change from baseline in the clinical assessment of dysmenorrhea
Time frame: Baseline to Week 4,8,12,24, and 26 or early discontinuation
3 secondary outcomes
Change from baseline in clinical assessment of dysmenorrhea (assessment of 4 additional symptoms)
Time frame: Baseline to Weeks 4, 8, 12, 24 and 26 or early discontinuation
Incidence of menstrual bleeding and/or spotting
Time frame: Duration of study
Analgesic use
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 12 May 2014.
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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.
18 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 levonorgestrel/EE 0.15/0.03 and EE 0.01 mg tablets in people with Dysmenorrhea, run by Duramed Research at 18 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 2 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 12 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 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?
Change from baseline in the clinical assessment of dysmenorrhea (time frame: Baseline to Week 4,8,12,24, and 26 or early discontinuation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 May 2014.