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

This study has been completed.

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

Sponsor:	Wyeth is now a wholly owned subsidiary of Pfizer
Information provided by:	Wyeth is now a wholly owned subsidiary of Pfizer
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:	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 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 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:	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 is now a wholly owned subsidiary of Pfizer

Investigators

Study Director:

Medical Monitor, MD

Wyeth is now a wholly owned subsidiary of Pfizer

More Information

No publications provided by Wyeth is now a wholly owned subsidiary of Pfizer

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Halbreich U, Freeman EW, Rapkin AJ, Cohen LS, Grubb GS, Bergeron R, Smith L, Mirkin S, Constantine GD. Continuous oral levonorgestrel/ethinyl estradiol for treating premenstrual dysphoric disorder. Contraception. 2012 Jan;85(1):19-27. Epub 2011 Jul 13.

ClinicalTrials.gov Identifier:	NCT00128934 History of Changes
Obsolete Identifiers:	NCT00278720
Other Study ID Numbers:	0858A4-316
Study First Received:	August 8, 2005
Last Updated:	December 18, 2007
Health Authority:	Canada: Health Canada; United States: Food and Drug Administration

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 February 09, 2012