Study Evaluating Combination of Levonorgestrel (LNG) and Ethinyl Estradiol (EE) in Premenstrual Dysphoric Disorder

This study has been completed.

First Received: August 8, 2005 Last Updated: December 18, 2007 History of Changes

Sponsored by:	Wyeth
Information provided by:	Wyeth
ClinicalTrials.gov Identifier:	NCT00128934

Purpose

The purpose of this study is to determine whether levonorgestrel (LNG)/ethinyl estradiol (EE) is effective in treating the symptoms of severe premenstrual syndrome (PMS).

Condition	Intervention	Phase
Menstruation Disturbances Premenstrual Syndrome	Drug: levonorgestrel/ethinyl estradiol	Phase III

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
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

Resource links provided by NLM:

MedlinePlus related topics: Menstruation Premenstrual Syndrome

Drug Information available for: Estradiol Estradiol 3-benzoate Ethinyl estradiol Polyestradiol phosphate Depogen Estradiol dipropionate Estradiol cypionate Levonorgestrel Estradiol valerate Estradiol acetate

U.S. FDA Resources

Further study details as provided by Wyeth:

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:	744
Study Start Date:	August 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 exclusions apply.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00128934

Show 83 Study Locations

Sponsors and Collaborators

Wyeth

Investigators

Study Director:

Medical Monitor, MD

Wyeth

More Information

No publications provided

Study ID Numbers:	0858A4-316
Study First Received:	August 8, 2005
Last Updated:	December 18, 2007
ClinicalTrials.gov Identifier:	NCT00128934 History of Changes
Health Authority:	Canada: Health Canada; United States: Food and Drug Administration

Keywords provided by Wyeth:

Premenstrual Syndrome (PMS)
Hormone Therapy

Study placed in the following topic categories:

Estrogens
Depression
Contraceptive Agents
Benzoates
Hormone Antagonists
Contraceptives, Oral
Estradiol valerate
Contraceptive Agents, Female
Hormones, Hormone Substitutes, and Hormone Antagonists
Ethinyl Estradiol
Estradiol 17 beta-cypionate

Depressive Disorder
Hormones
Estradiol
Menstruation Disturbances
Mental Disorders
Estradiol 3-benzoate
Levonorgestrel
Mood Disorders
Polyestradiol phosphate
Premenstrual Syndrome

Additional relevant MeSH terms:

Contraceptive Agents
Contraceptives, Oral
Estradiol valerate
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Contraceptive Agents, Female
Estradiol 17 beta-cypionate
Reproductive Control Agents
Hormones
Pathologic Processes
Menstruation Disturbances
Mental Disorders
Estradiol 3-benzoate

Syndrome
Levonorgestrel
Therapeutic Uses
Contraceptives, Oral, Synthetic
Polyestradiol phosphate
Estrogens
Disease
Ethinyl Estradiol
Depressive Disorder
Estradiol
Pharmacologic Actions
Mood Disorders
Premenstrual Syndrome

ClinicalTrials.gov processed this record on July 02, 2009