Premenstrual SyndromePhase 3NCT00161681
Study Evaluating Levonorgestrel/Ethinyl Estradiol (LNG/EE) in PMS
A Phase 3 study testing Levonorgestrel/Ethinyl Estradiol in people with Premenstrual Syndrome, run by Wyeth is now a wholly owned subsidiary of Pfizer at 48 sites in United States.
Trial summary
The purpose of this study is to determine whether LNG/EE is effective in the treatment of menstrual cycle related symptoms. Read more about this study
- Who is it for?
- Ages 18 to 49 years, women only
- Conditions the study is for
- Premenstrual Syndrome
- What is being tested?
- Levonorgestrel/Ethinyl Estradiol
- How many people
- 200 participants
- Where
- 48 sitesUnited States
- Study dates
- Jul 2005to Aug 2006
- 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 49 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Healthy women aged 18 to 49 years
- Regular 21 to 35 day menstrual cycles for 3 months prior to study visit 1
- History of menstrual cycle related symptoms as determined by the investigator.
Who cannot join
- Contraindication to combination oral contraceptives
- Depression requiring hospitalization or associated with suicidal ideation within the last 3 years
- Use of antidepressants/anxiolytics within 10 days of screening and for the duration of the study.
Trial locations and contacts
48 sites in 1 country.
48 sites in 1 country
United States48 sites
Study site
Atlanta, Georgia, 30328
Study site
Atlanta, Georgia, 30342
Study site
Aventura, Florida, 33180
Study site
Boynton Beach, Florida, 33437
Study site
Chicago, Illinois, 60612
Study site
Chicago, Illinois, 60631
Study site
Clearwater, Florida, 33761
Study site
Cleveland, Ohio, 44122
Study site
DeLand, Florida, 32720
Study site
Denver, Colorado, 80202
Study site
Eugene, Oregon, 97401
Study site
Fayetteville, North Carolina, 28304
Study site
Fort Myers, Florida, 33916
Study site
Hilton Head Island, South Carolina, 29926
Study site
Houston, Texas, 77024
Study site
Huntsville, Alabama, 35801
Study site
Idaho Falls, Idaho, 83404
Study site
Kansas City, Missouri, 64114
Study site
Lakewood, Washington, 98499
Study site
Las Vegas, Nevada, 89109
Study site
Las Vegas, Nevada, 89118
Study site
Lexington, Kentucky, 40509
Study site
Longmont, Colorado, 80501
Study site
Medford, Oregon, 97504
Study site
Miami, Florida, 33143
Study site
Miami, Florida, 33186
Study site
Mogadore, Ohio, 44260
Study site
Moorestown, New Jersey, 08057
Study site
Mt. Pleasant, South Carolina, 29464
Study site
Nashville, Tennessee, 37203
Study site
Pembroke Pines, Florida, 33024
Study site
Peoria, Arizona, 85381
Study site
Philadelphia, Pennsylvania, 19104
Study site
Phoenix, Arizona, 85031
Study site
Phoenix, Arizona, 85032
Study site
Pittsburgh, Pennsylvania, 15206
Study site
Richmond, Virginia, 23226
Study site
Rochester, New York, 14609
Study site
San Antonio, Texas, 78229
Study site
San Diego, California, 92103
Study site
Sandy City, Utah, 84070
Study site
Savannah, Georgia, 31406
Study site
Seattle, Washington, 98105
Study site
Tampa, Florida, 33607
Study site
Tucson, Arizona, 85715
Study site
West Palm Beach, Florida, 33407
Study site
Wexford, Pennsylvania, 15090
Study site
Winston-Salem, North Carolina, 27103
About this study
Official title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effect of Levonorgestrel 90 Mcg and Ethinyl Estradiol 20 Mcg in a Continuous Daily Regimen on Menstrual Cycle-Related Symptoms
The purpose of this study is to determine whether LNG/EE is effective in the treatment of menstrual cycle related symptoms.
- Conditions
- Premenstrual Syndrome
- Being tested
- Levonorgestrel/Ethinyl Estradiol
- Keywords
- Levonorgestrel, ethinyl estradiol, premenstrual syndrome, menstrual cycle related symptoms
- Medical subject headings
- Premenstrual Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Levonorgestrel/Ethinyl EstradiolDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the efficacy of a continuous-use OC regimen containing a combination of LNG/EE in preventing moderate to severe cycle-related symptoms compared with placebo
Secondary outcomes (1)
To evaluate the effects of this LNG/EE regimen on work productivity and subject satisfaction in subjects with moderate to severe cycle-related symptoms at baseline compared with placebo
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2005 (estimated)
- Study startJul 2005
- Primary completionAug 2006
- Study completionAug 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premenstrual SyndromeStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 200 participants
Sponsor and investigators
- Lead sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Monitor, MD, Study director, Wyeth is now a wholly owned subsidiary of Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00161681
- Sponsor's protocol ID
- 0858A2-322
- Other IDs
- B3121024
- Status last verified
- May 2007
- First submitted
- 7 Sep 2005
- Last updated
- 8 Feb 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effect of Levonorgestrel 90 Mcg and Ethinyl Estradiol 20 Mcg in a Continuous Daily Regimen on Menstrual Cycle-Related Symptoms
- ClinicalTrials.gov ID
- NCT00161681
- Acronym / sponsor ID
- 0858A2-322
- Conditions
- Premenstrual Syndrome
- Keywords
- Levonorgestrel, ethinyl estradiol, premenstrual syndrome, menstrual cycle related symptoms
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants
- Lead sponsor
- Wyeth is now a wholly owned subsidiary of PfizerIndustry (pharma, biotech, devices)
- Study start
- Jul 2005
- Primary completion
- Aug 2006 (actual)
- Study completion
- Aug 2006 (actual)
- First posted
- 12 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.
The purpose of this study is to determine whether LNG/EE is effective in the treatment of menstrual cycle related symptoms.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy women aged 18 to 49 years
- Regular 21 to 35 day menstrual cycles for 3 months prior to study visit 1
- History of menstrual cycle related symptoms as determined by the investigator.
Key exclusion criteria (3 listed)
- Contraindication to combination oral contraceptives
- Depression requiring hospitalization or associated with suicidal ideation within the last 3 years
- Use of antidepressants/anxiolytics within 10 days of screening and for the duration of the study.
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/Ethinyl Estradiol | Drug | – |
Primary outcome
To evaluate the efficacy of a continuous-use OC regimen containing a combination of LNG/EE in preventing moderate to severe cycle-related symptoms compared with placebo
1 secondary outcome
To evaluate the effects of this LNG/EE regimen on work productivity and subject satisfaction in subjects with moderate to severe cycle-related symptoms at baseline compared with placebo
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 8 Feb 2013.
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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.
Medical Monitor, MD study director
Wyeth is now a wholly owned subsidiary of Pfizer
48 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/Ethinyl Estradiol in people with Premenstrual Syndrome, run by Wyeth is now a wholly owned subsidiary of Pfizer at 48 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 8 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 48 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?
To evaluate the efficacy of a continuous-use OC regimen containing a combination of LNG/EE in preventing moderate to severe cycle-related symptoms compared with placebo. 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 8 Feb 2013.