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

This study has been completed.
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00195559
First received: September 13, 2005
Last updated: December 18, 2007
Last verified: December 2007
History of Changes
  Purpose

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:

U.S. FDA Resources

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
  Eligibility

Ages Eligible for Study:   18 Years to 49 Years
Genders 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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00195559

  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
  More Information

No publications provided

ClinicalTrials.gov 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
Polyestradiol phosphate
Ethinyl Estradiol
Estradiol valerate
Estradiol 3-benzoate
Estradiol 17 beta-cypionate
Levonorgestrel
Estrogens
 Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Contraceptive Agents
Reproductive Control Agents
Therapeutic Uses
Contraceptive Agents, Female
Contraceptives, Oral, Synthetic
Contraceptives, Oral

ClinicalTrials.gov processed this record on May 16, 2013