Study Evaluating Combination of Levonorgestrel and Ethinyl Estradiol in Pre-Menstrual Dysphoric Disorder
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT00195559 |
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Recruitment Status :
Completed
First Posted : September 19, 2005
Last Update Posted : December 27, 2007
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Sponsor:
Wyeth is now a wholly owned subsidiary of Pfizer
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
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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.
| 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 |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double |
| Primary Purpose: | Prevention |
| 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 |
Resource links provided by the National Library of Medicine
Primary Outcome Measures :
- Mean change in average Daily Record of Severity of Problems (DRSP) 21-item total daily score
Secondary Outcome Measures :
- Change from baseline in DRSP 21-item daily score based on the 5 days with the highest DRSP scores in each "estimated" treatment cycle
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years to 49 Years (Adult) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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.
Information from the National Library of Medicine
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
Locations
Show 52 study locations
Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
| Principal Investigator: | Trial Manager | For Argentina, Chile, scheima@wyeth.com | |
| Principal Investigator: | Trial Manager | For Brazil, xavierl@wyeth.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, gomezlj@wyeth.com | |
| 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, ukmedinfo@wyeth.com |
| ClinicalTrials.gov Identifier: | NCT00195559 |
| Other Study ID Numbers: |
0858A4-318 |
| First Posted: | September 19, 2005 Key Record Dates |
| Last Update Posted: | December 27, 2007 |
| Last Verified: | December 2007 |
Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:
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Premenstrual Syndrome (PMS) Hormone Therapy |
Additional relevant MeSH terms:
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Premenstrual Syndrome Menstruation Disturbances Pathologic Processes Levonorgestrel Ethinyl Estradiol Estradiol Estrogens Hormones Hormones, Hormone Substitutes, and Hormone Antagonists |
Physiological Effects of Drugs Contraceptive Agents, Hormonal Contraceptive Agents Reproductive Control Agents Contraceptive Agents, Female Contraceptives, Oral, Synthetic Contraceptives, Oral Contraceptives, Oral, Hormonal |