Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
Wyeth |
---|---|
Information provided by: | Wyeth |
ClinicalTrials.gov Identifier: | NCT00128934 |
The purpose of this study is to determine whether levonorgestrel (LNG)/ethinyl estradiol (EE) is effective in treating the symptoms of severe premenstrual syndrome (PMS).
Condition | Intervention | Phase |
---|---|---|
Menstruation Disturbances Premenstrual Syndrome |
Drug: levonorgestrel/ethinyl estradiol |
Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of a Combination of Levonorgestrel and Ethinyl Estradiol in a Continuous Daily Regimen in Subjects With Premenstrual Dysphoric Disorder |
Estimated Enrollment: | 744 |
Study Start Date: | August 2005 |
Study Completion Date: | December 2007 |
Ages Eligible for Study: | 18 Years to 49 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Other exclusions apply.
Study Director: | Medical Monitor, MD | Wyeth |
Study ID Numbers: | 0858A4-316 |
Study First Received: | August 8, 2005 |
Last Updated: | December 18, 2007 |
ClinicalTrials.gov Identifier: | NCT00128934 |
Health Authority: | Canada: Health Canada; United States: Food and Drug Administration |
Premenstrual Syndrome (PMS) Hormone Therapy |
Depression Benzoates Estradiol valerate Ethinyl Estradiol Estradiol 17 beta-cypionate Depressive Disorder Estradiol |
Menstruation Disturbances Mental Disorders Estradiol 3-benzoate Levonorgestrel Mood Disorders Polyestradiol phosphate Premenstrual Syndrome |
Estrogens Disease Contraceptive Agents Contraceptives, Oral Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Contraceptive Agents, Female |
Reproductive Control Agents Hormones Pharmacologic Actions Pathologic Processes Syndrome Therapeutic Uses Contraceptives, Oral, Synthetic |