We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00195559
First Posted: September 19, 2005
Last Update Posted: December 27, 2007
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.
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
  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
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

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
  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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.

  Contacts and Locations
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


  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

ClinicalTrials.gov Identifier: NCT00195559     History of Changes
Other Study ID Numbers: 0858A4-318
First Submitted: September 13, 2005
First Posted: September 19, 2005
Last Update Posted: December 27, 2007
Last Verified: December 2007

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

Additional relevant MeSH terms:
Premenstrual Syndrome
Premenstrual Dysphoric Disorder
Menstruation Disturbances
Pathologic Processes
Depressive Disorder
Mood Disorders
Mental Disorders
Estradiol
Polyestradiol phosphate
Ethinyl Estradiol
Estradiol 3-benzoate
Estradiol 17 beta-cypionate
Estradiol valerate
Levonorgestrel
Ethinyl estradiol, levonorgestrel drug combination
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
Contraceptives, Oral, Combined