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

This study has been completed.

Sponsor:

Information provided by:

Wyeth is now a wholly owned subsidiary of Pfizer

ClinicalTrials.gov Identifier:

NCT00128934

First received: August 8, 2005

Last updated: December 18, 2007

Last verified: December 2007

History of Changes

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 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 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: Premenstrual Syndrome

Drug Information available for: Estradiol Ethinylestradiol Estradiol cypionate Levonorgestrel Estradiol valerate Estradiol acetate Estradiol hemihydrate

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 (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 exclusions apply.

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 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

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. doi: 10.1016/j.contraception.2011.05.008. 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

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

ClinicalTrials.gov processed this record on August 18, 2017

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