Study Evaluating Levonorgestrel/Ethinyl Estradiol (LNG/EE) in PMS - Full Text View

Sponsor:	Wyeth
Information provided by:	Wyeth
ClinicalTrials.gov Identifier:	NCT00161681

Purpose

The purpose of this study is to determine whether LNG/EE is effective in the treatment of menstrual cycle related symptoms.

Condition	Intervention	Phase
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 Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effect of Levonorgestrel 90 Mcg and Ethinyl Estradiol 20 Mcg in a Continuous Daily Regimen on Menstrual Cycle-Related Symptoms

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:

To evaluate the efficacy of a continuous-use OC regimen containing a combination of LNG/EE in preventing moderate to severe cycle-related symptoms compared with placebo

Secondary Outcome Measures:

To evaluate the effects of this LNG/EE regimen on work productivity and subject satisfaction in subjects with moderate to severe cycle-related symptoms at baseline compared with placebo

Estimated Enrollment:	200
Study Start Date:	August 2005

Eligibility

Ages Eligible for Study:	18 Years to 49 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Healthy women aged 18 to 49 years
Regular 21 to 35 day menstrual cycles for 3 months prior to study visit 1
History of menstrual cycle related symptoms as determined by the investigator.

Exclusion Criteria:

Contraindication to combination oral contraceptives
Depression requiring hospitalization or associated with suicidal ideation within the last 3 years
Use of antidepressants/anxiolytics within 10 days of screening and for the duration of the study.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00161681

Show 48 Study Locations

Sponsors and Collaborators

Wyeth

Investigators

Study Director:

Medical Monitor, MD

Wyeth

More Information

No publications provided

Study ID Numbers:	0858A2-322
Study First Received:	September 7, 2005
Last Updated:	May 25, 2007
ClinicalTrials.gov Identifier:	NCT00161681 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Wyeth:

Levonorgestrel
ethinyl estradiol
premenstrual syndrome
menstrual cycle related symptoms

Additional relevant MeSH terms:

Estrogens
Disease
Contraceptive Agents
Contraceptives, Oral
Physiological Effects of Drugs
Estradiol valerate
Contraceptive Agents, Female
Hormones, Hormone Substitutes, and Hormone Antagonists
Ethinyl Estradiol
Reproductive Control Agents
Estradiol 17 beta-cypionate
Hormones

Pharmacologic Actions
Estradiol
Pathologic Processes
Menstruation Disturbances
Therapeutic Uses
Syndrome
Estradiol 3-benzoate
Levonorgestrel
Contraceptives, Oral, Synthetic
Polyestradiol phosphate
Premenstrual Syndrome

ClinicalTrials.gov processed this record on November 27, 2009