Study Evaluating Combination of Levonorgestrel (LNG) and Ethinyl Estradiol (EE) in Premenstrual Dysphoric Disorder
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ClinicalTrials.gov Identifier: NCT00128934 |
Recruitment Status :
Completed
First Posted : August 10, 2005
Last Update Posted : December 27, 2007
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Menstruation Disturbances Premenstrual Syndrome | Drug: levonorgestrel/ethinyl estradiol | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 744 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double |
Primary Purpose: | Prevention |
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 |
Study Start Date : | August 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 |
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 exclusions apply.

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): NCT00128934

Study Director: | Medical Monitor, MD | Wyeth is now a wholly owned subsidiary of Pfizer |
ClinicalTrials.gov Identifier: | NCT00128934 |
Obsolete Identifiers: | NCT00278720 |
Other Study ID Numbers: |
0858A4-316 |
First Posted: | August 10, 2005 Key Record Dates |
Last Update Posted: | December 27, 2007 |
Last Verified: | December 2007 |
Premenstrual Syndrome (PMS) Hormone Therapy |
Premenstrual Syndrome Premenstrual Dysphoric Disorder Menstruation Disturbances Pathologic Processes Depressive Disorder Mood Disorders Mental Disorders Levonorgestrel Estradiol Ethinyl Estradiol |
Estrogens Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Contraceptive Agents Reproductive Control Agents Contraceptive Agents, Female Contraceptives, Oral, Synthetic Contraceptives, Oral |