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Drospirenone and Ethinyl Estradiol |
drospirenone 3.0mg and ethinyl estradiol 0.030mg; Yasmin |
Clinical Trial: Study Evaluating Combination of Levonorgestrel and Ethinyl Estradiol in Pre-Menstrual Dysporic Disorder
This study is currently recruiting patients.
Verified by Wyeth August 2005
|
Purpose
The purpose of this study is to determine whether LNG/EE is effective in treating the symptoms of severe PMS.
| Condition | Intervention | Phase |
|---|---|---|
| Premenstrual Dysphoric Disorder | Drug: Levonorgestrel/Ethinyl Estradiol | Phase III |
MedlinePlus related topics: Mental Health; Premenstrual Syndrome
Study Type: Interventional
Study Design: Treatment, 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 Dysporic Disorder
Further Study Details:
Primary Outcomes: Mean change in average Daily record of Severity of Problems 21-item total daily score
Secondary Outcomes: Change from baseline in DRSP 21 item daily score based on the 5 days with highest DRSP scores in each "estimated" treatment cycle.
Expected Total Enrollment: 744
Secondary Outcomes: Change from baseline in DRSP 21 item daily score based on the 5 days with highest DRSP scores in each "estimated" treatment cycle.
Expected Total Enrollment: 744
Study start: August 2005
Eligibility
Ages Eligible for Study: 18 Years - 49 Years, Genders Eligible for Study: Female
Criteria
Inclusion Criteria:
- Generally healthy, outpatient women aged 18 to 49 years who meet criteria for severe PMS and who are willing to take a combination OC
- Subjects must not be at risk for pregnancy during the study, or they must be using an effective, nonhormonal method of birth control or must be practicing complete abstinence.
Exclusion Criteria:
- Major depressive disorder requiring antidepressant treatment or hospitalization
- Age=34 years and smoking=15 cigarettes per day; age=34 years and smoking cigarettes (Canadian sites only)
Other exclusion applies.
Location and Contact Information
Please refer to this study by ClinicalTrials.gov identifier NCT00128934
Trial Manager clinicaltrialinfo@wyeth.com
California
San Diego, California, 92103, United States; Recruiting
see Central Contact
Colorado
Lakewood, Colorado, 80228, United States; Recruiting
see Central Contact
Georgia
Atlanta, Georgia, 30328, United States; Recruiting
see Central Contact
Savannah, Georgia, 31406, United States; Recruiting
see Central Contact
Ohio
Cleveland, Ohio, 44122, United States; Recruiting
see Central Contact
Pennsylvania
Philadelphia, Pennsylvania, 19104, United States; Recruiting
see Central Contact
Virginia
Richmond, Virginia, 23294, United States; Recruiting
see Central Contact
Study chairs or principal investigators
Medical Monitor, MD, Study Director, Wyeth Research
More Information
Study ID Numbers: 0858A4-316
Last Updated: August 9, 2005
Record first received: August 8, 2005
ClinicalTrials.gov Identifier: NCT00128934
Health Authority: United States: Food and Drug Administration; Canada: Health Canada
ClinicalTrials.gov processed this record on 2005-08-23
Last Updated: August 9, 2005
Record first received: August 8, 2005
ClinicalTrials.gov Identifier: NCT00128934
Health Authority: United States: Food and Drug Administration; Canada: Health Canada
ClinicalTrials.gov processed this record on 2005-08-23
Resources
- Drospirenone and Ethinyl Estradiol (Drug Digest)
- Yasmin (Drug Digest)
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