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Study Evaluating Combination of Levonorgestrel and Ethinyl Estradiol in Pre-Menstrual Dysphoric Disorder

This study has been completed.
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer Identifier:
First received: September 13, 2005
Last updated: December 18, 2007
Last verified: December 2007

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 Intervention Phase
Premenstrual Syndrome
Menstruation Disturbances
Drug: Levonorgestrel/Ethinyl Estradiol
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Resource links provided by NLM:

Further study details as provided by Wyeth is now a wholly owned subsidiary of Pfizer:

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

Estimated Enrollment: 526
Study Start Date: September 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:

  • 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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00195559

  Show 52 Study Locations
Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Principal Investigator: Trial Manager For Argentina, Chile,
Principal Investigator: Trial Manager For Brazil,
Principal Investigator: Trial Manager For Denmark, Finland, Sweden,
Principal Investigator: Trial Manager For Germany,
Principal Investigator: Trial Manager For Mexico,
Principal Investigator: Trial Manager For Netherlands,
Principal Investigator: Trial Managersp For Poland,
Principal Investigator: Trial Manager For Romania,
Principal Investigator: Trial Manager For UK,
  More Information

No publications provided Identifier: NCT00195559     History of Changes
Other Study ID Numbers: 0858A4-318
Study First Received: September 13, 2005
Last Updated: December 18, 2007
Health Authority: Poland: Ministry of Health

Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:
Premenstrual Syndrome (PMS)
Hormone Therapy

Additional relevant MeSH terms:
Menstruation Disturbances
Premenstrual Syndrome
Pathologic Processes
Estradiol 17 beta-cypionate
Estradiol 3-benzoate
Estradiol valerate
Ethinyl Estradiol
Ethinyl estradiol, levonorgestrel drug combination
Polyestradiol phosphate
Contraceptive Agents
Contraceptive Agents, Female
Contraceptives, Oral
Contraceptives, Oral, Combined
Contraceptives, Oral, Synthetic
Hormones, Hormone Substitutes, and Hormone Antagonists
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents
Therapeutic Uses processed this record on November 24, 2014