Not Signed In -
Menstruation |
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Clinical Trial: Study Evaluating Combination of Levonorgestrel and Ethinyl Estradiol in Pre-Menstrual Dysphoric Disorder
This study is not yet open for patient recruitment.
Verified by Wyeth September 2005
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
| Premenstrual Syndrome Menstruation Disturbances | Drug: Levonorgestrel/Ethinyl Estradiol | Phase III |
MedlinePlus related topics: Menstruation; Premenstrual Syndrome
Study Type: Interventional
Study Design: Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy 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
Further Study Details:
Primary Outcomes: Mean change in average Daily Record of Severity of Problems (DRSP) 21-item total daily score
Secondary Outcomes: Change from baseline in DRSP 21-item daily score based on the 5 days with the highest DRSP scores in each "estimated" treatment cycle
Expected Total Enrollment: 526
Secondary Outcomes: Change from baseline in DRSP 21-item daily score based on the 5 days with the highest DRSP scores in each "estimated" treatment cycle
Expected Total Enrollment: 526
Study start: September 2005
Eligibility
Ages Eligible for Study: 18 Years - 49 Years, Genders Eligible for Study: Female
Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Location and Contact Information
Please refer to this study by ClinicalTrials.gov identifier NCT00195559
Trial Manager clinicaltrialinfo@wyeth.com
Argentina
Buenos Aires, Argentina
see Central Contact
Ciudad Autonoma de Buenos Aires, Argentina
see Central Contact
Rosario - Santa Fe, Argentina
see Central Contact
Buenos Aires, Argentina
see Central Contact
Cordoba, Argentina
see Central Contact
Brazil
Sao Paulo, Brazil
see Central Contact
Sorocaba, Brazil
see Central Contact
Salvador, Brazil
see Central Contact
Porto Alegre, Brazil
see Central Contact
Curitiba, Brazil
see Central Contact
Goiania, Brazil
see Central Contact
Chile
Santiago, Chile
see Central Contact
Temuco, Chile
see Central Contact
Denmark
Kobenhavn NV, Denmark
see Central Contact
Arhus, Denmark
see Central Contact
Rungsted Kyst, Denmark
see Central Contact
Frederiksberg, Denmark
see Central Contact
Finland
Helsinki, Finland
see Central Contact
Oulu, Finland
see Central Contact
Kuopio, Finland
see Central Contact
Turku, Finland
see Central Contact
Germany
Berlin, Germany
see Central Contact
Hannover, Germany
see Central Contact
Bonn, Germany
see Central Contact
Hamburg, Germany
see Central Contact
Mexico
Mexico City, Mexico
see Central Contact
Mexico, D.F.
Lomas de Virreyes, D.F., Mexico
see Central Contact
Mexico, Jalisco
Zapopan, Jalisco, Mexico
see Central Contact
Guadalajara, Jalisco, Mexico
see Central Contact
Mexico, N.L.
Monterrey, N.L., Mexico
see Central Contact
Mexico, SLP
San Luis Potosi, SLP, Mexico
see Central Contact
Netherlands
Den Helder, Netherlands
see Central Contact
Nieuwegein, Netherlands
see Central Contact
Apeldoorn, Netherlands
see Central Contact
ENSCHEDE, Netherlands
see Central Contact
Amsterdam, Netherlands
see Central Contact
Poland
Poznan, Poland
see Central Contact
Gdansk, Poland
see Central Contact
Myslowice, Poland
see Central Contact
Warszawa, Poland
see Central Contact
Bialystok, Poland
see Central Contact
Romania
Iasi, Romania
see Central Contact
Bucuresti, Romania
see Central Contact
Cluj Napoca, Romania
see Central Contact
Sweden
Stockholm, Sweden
see Central Contact
Umea, Sweden
see Central Contact
Uppsala, Sweden
see Central Contact
Goteborg, Sweden
see Central Contact
United Kingdom
London, United Kingdom
see Central Contact
Fowey, United Kingdom
see Central Contact
St. Austell, United Kingdom
see Central Contact
Plymouth, United Kingdom
see Central Contact
Conwell, United Kingdom
see Central Contact
Study chairs or principal investigators
Medical Monitor, Study Director, Wyeth Research
More Information
Study ID Numbers: 0858A4-318
Last Updated: September 19, 2005
Record first received: September 13, 2005
ClinicalTrials.gov Identifier: NCT00195559
Health Authority: Poland: Ministry of Health
ClinicalTrials.gov processed this record on 2005-09-20
Last Updated: September 19, 2005
Record first received: September 13, 2005
ClinicalTrials.gov Identifier: NCT00195559
Health Authority: Poland: Ministry of Health
ClinicalTrials.gov processed this record on 2005-09-20
Resources
- A Guide to Polycystic Ovary Syndrome (Center for Young Women's Health)
- A Guide to Puberty and Menstrual Cycles (Center for Young Women's Health)
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