Premenstrual SyndromePhase 3NCT00195559
Study Evaluating Combination of Levonorgestrel and Ethinyl Estradiol in Pre-Menstrual Dysphoric Disorder
A Phase 3 study testing Levonorgestrel/Ethinyl Estradiol in people with Premenstrual Syndrome and Menstruation Disturbances, run by Wyeth is now a wholly owned subsidiary of Pfizer at 51 sites in 12 countries.
Trial summary
The purpose of this study is to determine whether Levonorgestrel/Ethinyl Estradiol (LNG/EE) is effective in treating the symptoms of severe Premenstrual Dysphoric Disorder. Read more about this study
- Who is it for?
- Ages 18 to 49 years, women only
- Conditions the study is for
- Premenstrual Syndrome, Menstruation Disturbances
- What is being tested?
- Levonorgestrel/Ethinyl Estradiol
- How many people
- 526 participants
- Where
- 51 sitesin 12 countries
- Study dates
- Sep 2005to Dec 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 49 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Generally healthy, women aged 18 to 49 years.
- History of severe PMS symptoms over the last year, as determined by the investigator.
- Regular 21 to 35 day menstrual cycle for 2 months prior to first study visit.
Who cannot join
- Major depressive disorder requiring antidepressant treatment or hospitalization within the last 3 years.
- Contraindication to combination oral contraceptives.
- Use of antidepressants/anxiolytics within 10 days of screening and for the duration of the study.
- Other exclusion applies.
Trial locations and contacts
51 sites in 12 countries.
51 sites in 12 countries
Brazil6 sites
Study site
Curitiba
Study site
Goiânia
Study site
Porto Alegre
Study site
Salvador
Study site
São Paulo
Study site
Sorocaba
Mexico6 sites
Study site
Guadalajara, Jalisco
Study site
Lomas de Virreyes, D.F.
Study site
Mexico City
Study site
Monterrey, N.L.
Study site
San Luis Potosí City, San Luis Potosí
Study site
Zapopan, Jalisco
Netherlands5 sites
Study site
Amsterdam
Study site
Apeldoorn
Study site
Den Helder
Study site
Enschede
Study site
Nieuwegein
Poland5 sites
Study site
Bialystok
Study site
Gdansk
Study site
Mysłowice
Study site
Poznan
Study site
Warsaw
United Kingdom5 sites
Study site
Conwell
Study site
Fowey
Study site
London
Study site
Plymouth
Study site
St Austell
Denmark4 sites
Study site
Aarhus
Study site
Frederiksberg
Study site
København NV
Study site
Rungsted Kyst
Finland4 sites
Study site
Helsinki
Study site
Kuopio
Study site
Oulu
Study site
Turku
Germany4 sites
Study site
Berlin
Study site
Bonn
Study site
Hamburg
Study site
Hanover
Sweden4 sites
Study site
Gothenburg
Study site
Stockholm
Study site
Umeå
Study site
Uppsala
Argentina3 sites
Study site
Buenos Aires
Study site
Córdoba
Study site
Rosario-Santa Fe
About this study
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of a Combination of Levonorgestrel and Ethinyl Estradiol in a Continuous Daily Regimen in Subjects With Premenstrual Dysphoric Disorder
The purpose of this study is to determine whether Levonorgestrel/Ethinyl Estradiol (LNG/EE) is effective in treating the symptoms of severe Premenstrual Dysphoric Disorder.
- Conditions
- Premenstrual Syndrome, Menstruation Disturbances
- Being tested
- Levonorgestrel/Ethinyl Estradiol
- Keywords
- Premenstrual Syndrome (PMS), Hormone Therapy
- Medical subject headings
- Premenstrual Syndrome, Menstruation Disturbances
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.
Mean change in average Daily Record of Severity of Problems (DRSP) 21-item total daily score
Secondary outcomes (1)
Change from baseline in DRSP 21-item daily score based on the 5 days with the highest DRSP scores in each "estimated" treatment cycle
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2005 (estimated)
- Study startSep 2005
- Study completionDec 2007
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
- 526 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Trial Manager, Principal investigator, For Argentina, Chile, scheima@wyeth.comTrial Manager, Principal investigator, For Brazil, xavierl@wyeth.comTrial Manager, Principal investigator, For Denmark, Finland, Sweden, MedInfoNord@wyeth.comTrial Manager, Principal investigator, For Germany, MedinfoDEU@wyeth.comTrial Manager, Principal investigator, For Mexico, gomezlj@wyeth.comTrial Manager, Principal investigator, For Netherlands, trials-NL@wyeth.comTrial Managersp, Principal investigator, For Poland, WPWZMED@wyeth.comTrial Manager, Principal investigator, For Romania, WPVIMED@wyeth.com
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00195559
- Sponsor's protocol ID
- 0858A4-318
- Status last verified
- Dec 2007
- First submitted
- 13 Sep 2005
- Last updated
- 27 Dec 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of a Combination of Levonorgestrel and Ethinyl Estradiol in a Continuous Daily Regimen in Subjects With Premenstrual Dysphoric Disorder
- ClinicalTrials.gov ID
- NCT00195559
- Acronym / sponsor ID
- 0858A4-318
- Conditions
- Premenstrual Syndrome, Menstruation Disturbances
- Keywords
- Premenstrual Syndrome (PMS), Hormone Therapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 526 participants (estimated)
- Lead sponsor
- Wyeth is now a wholly owned subsidiary of PfizerIndustry (pharma, biotech, devices)
- Study start
- Sep 2005
- Study completion
- Dec 2007 (actual)
- First posted
- 19 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 Levonorgestrel/Ethinyl Estradiol (LNG/EE) is effective in treating the symptoms of severe Premenstrual Dysphoric Disorder.
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)
- Generally healthy, women aged 18 to 49 years.
- History of severe PMS symptoms over the last year, as determined by the investigator.
- Regular 21 to 35 day menstrual cycle for 2 months prior to first study visit.
Key exclusion criteria (4 listed)
- Major depressive disorder requiring antidepressant treatment or hospitalization within the last 3 years.
- Contraindication to combination oral contraceptives.
- Use of antidepressants/anxiolytics within 10 days of screening and for the duration of the study.
- Other exclusion applies.
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
Mean change in average Daily Record of Severity of Problems (DRSP) 21-item total daily score
1 secondary outcome
Change from baseline in DRSP 21-item daily score based on the 5 days with the highest DRSP scores in each "estimated" treatment cycle
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 27 Dec 2007.
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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.
Trial Manager principal investigator
For Argentina, Chile, scheima@wyeth.com
Trial Manager principal investigator
For Brazil, xavierl@wyeth.com
Trial Manager principal investigator
For Denmark, Finland, Sweden, MedInfoNord@wyeth.com
51 sites in 12 countries: 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 and Menstruation Disturbances, run by Wyeth is now a wholly owned subsidiary of Pfizer at 51 sites in 12 countries.
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 4 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 27 Dec 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 51 sites in Brazil, Mexico, Netherlands, Poland, United Kingdom and 7 more countries. 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?
Mean change in average Daily Record of Severity of Problems (DRSP) 21-item total daily score. 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 27 Dec 2007.