Study Evaluating Combination of Levonorgestrel and Ethinyl Estradiol in Pre-Menstrual Dysphoric Disorder
NCT00195559
ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
- 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.
- 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.
NEED INFO?
Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

TRY A NEW SEARCH
Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.
Based on your search, you may also be interested in
- Buenos Aires,
- Ciudad Autonoma de Buenos Aires,
- Cordoba,
- Rosario-Santa Fe,
- Curitiba,
- Goiania,
- Porto Alegre,
- Salvador,
- Sao Paulo,
- Sorocaba,
- Santiago,
- Temuco,
- Arhus,
- Frederiksberg,
- Kobenhavn NV,
- Rungsted Kyst,
- Helsinki,
- Kuopio,
- Oulu,
- Turku,
- Berlin,
- Bonn,
- Hamburg,
- Hannover,
- Lomas de Virreyes, D.f.
- Guadalajara, Jalisco
- Zapopan, Jalisco
- Monterrey, N.l.
- San Luis Potosi, SLP
- Mexico City,
- Amsterdam,
- Apeldoorn,
- Den Helder,
- Enschede,
- Nieuwegein,
- Bialystok,
- Gdansk,
- Myslowice,
- Poznan,
- Warszawa,
- Bucuresti,
- Cluj-Napoca,
- Iasi,
- Goteborg,
- Stockholm,
- Umea,
- Uppsala,
- Conwell,
- Fowey,
- London,
- Plymouth,
- St. Austell,
Descriptive Information | ||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Brief Title ICMJE | Study Evaluating Combination of Levonorgestrel and Ethinyl Estradiol in Pre-Menstrual Dysphoric Disorder | |||||||||||||||||||||||||||
Official Title ICMJE | 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 | |||||||||||||||||||||||||||
Brief 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. | |||||||||||||||||||||||||||
Detailed Description | Not Provided | |||||||||||||||||||||||||||
Study Type ICMJE | Interventional | |||||||||||||||||||||||||||
Study Phase ICMJE | Phase 3 | |||||||||||||||||||||||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Primary Purpose: Prevention | |||||||||||||||||||||||||||
Condition ICMJE |
| |||||||||||||||||||||||||||
Intervention ICMJE | Drug: Levonorgestrel/Ethinyl Estradiol | |||||||||||||||||||||||||||
Study Arms ICMJE | Not Provided | |||||||||||||||||||||||||||
Publications * | Not Provided | |||||||||||||||||||||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||||||||||||||||||||||||||
Recruitment Information | ||||||||||||||||||||||||||||
Recruitment Status ICMJE | Completed | |||||||||||||||||||||||||||
Estimated Enrollment ICMJE | 526 | |||||||||||||||||||||||||||
Original Enrollment ICMJE | Same as current | |||||||||||||||||||||||||||
Actual Study Completion Date ICMJE | December 2007 | |||||||||||||||||||||||||||
Primary Completion Date | Not Provided | |||||||||||||||||||||||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
Other exclusion applies. | |||||||||||||||||||||||||||
Sex/Gender ICMJE |
| |||||||||||||||||||||||||||
Ages ICMJE | 18 Years to 49 Years (Adult) | |||||||||||||||||||||||||||
Accepts Healthy Volunteers ICMJE | No | |||||||||||||||||||||||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||||||||||||||||||||||||||
Listed Location Countries ICMJE | Argentina, Brazil, Chile, Denmark, Finland, Germany, Mexico, Netherlands, Poland, Romania, Sweden, United Kingdom | |||||||||||||||||||||||||||
Removed Location Countries | ||||||||||||||||||||||||||||
Administrative Information | ||||||||||||||||||||||||||||
NCT Number ICMJE | NCT00195559 | |||||||||||||||||||||||||||
Other Study ID Numbers ICMJE | 0858A4-318 | |||||||||||||||||||||||||||
Has Data Monitoring Committee | Not Provided | |||||||||||||||||||||||||||
U.S. FDA-regulated Product | Not Provided | |||||||||||||||||||||||||||
IPD Sharing Statement ICMJE | Not Provided | |||||||||||||||||||||||||||
Responsible Party | Not Provided | |||||||||||||||||||||||||||
Study Sponsor ICMJE | Wyeth is now a wholly owned subsidiary of Pfizer | |||||||||||||||||||||||||||
Collaborators ICMJE | Not Provided | |||||||||||||||||||||||||||
Investigators ICMJE |
| |||||||||||||||||||||||||||
PRS Account | Wyeth is now a wholly owned subsidiary of Pfizer | |||||||||||||||||||||||||||
Verification Date | December 2007 | |||||||||||||||||||||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |