Study Evaluating Combination of Levonorgestrel and Ethinyl Estradiol in Pre-Menstrual Dysphoric Disorder
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|ClinicalTrials.gov Identifier: NCT00195559|
Recruitment Status : Completed
First Posted : September 19, 2005
Last Update Posted : December 27, 2007
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|Condition or disease||Intervention/treatment||Phase|
|Premenstrual Syndrome Menstruation Disturbances||Drug: Levonorgestrel/Ethinyl Estradiol||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||526 participants|
|Intervention Model:||Parallel Assignment|
|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|
|Study Start Date :||September 2005|
|Actual Study Completion Date :||December 2007|
- Mean change in average Daily Record of Severity of Problems (DRSP) 21-item total daily score
- Change from baseline in DRSP 21-item daily score based on the 5 days with the highest DRSP scores in each "estimated" treatment cycle
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|Ages Eligible for Study:||18 Years to 49 Years (Adult)|
|Sexes Eligible for Study:||Female|
|Accepts Healthy Volunteers:||No|
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00195559
|Principal Investigator:||Trial Manager||For Argentina, Chile, firstname.lastname@example.org|
|Principal Investigator:||Trial Manager||For Brazil, email@example.com|
|Principal Investigator:||Trial Manager||For Denmark, Finland, Sweden, MedInfoNord@wyeth.com|
|Principal Investigator:||Trial Manager||For Germany, MedinfoDEU@wyeth.com|
|Principal Investigator:||Trial Manager||For Mexico, firstname.lastname@example.org|
|Principal Investigator:||Trial Manager||For Netherlands, trials-NL@wyeth.com|
|Principal Investigator:||Trial Managersp||For Poland, WPWZMED@wyeth.com|
|Principal Investigator:||Trial Manager||For Romania, WPVIMED@wyeth.com|
|Principal Investigator:||Trial Manager||For UK, email@example.com|
|Other Study ID Numbers:||
|First Posted:||September 19, 2005 Key Record Dates|
|Last Update Posted:||December 27, 2007|
|Last Verified:||December 2007|
Premenstrual Syndrome (PMS)
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Contraceptive Agents, Hormonal
Reproductive Control Agents
Contraceptive Agents, Female
Contraceptives, Oral, Synthetic
Contraceptives, Oral, Hormonal