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NCT00161681 Clinical Trial

Study Evaluating Levonorgestrel/Ethinyl Estradiol (LNG/EE) in PMS

Premenstrual Syndrome Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00161681
Other study ID # 0858A2-322
Secondary ID B3121024
Status Completed
Phase Phase 3
First received September 7, 2005
Last updated February 7, 2013
Start date July 2005
Est. completion date August 2006

Study information
Verified date May 2007
Source Wyeth is now a wholly owned subsidiary of Pfizer
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 200
Est. completion date August 2006
Est. primary completion date August 2006
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 49 Years
Eligibility 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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Drug:
• Levonorgestrel/Ethinyl Estradiol

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Wyeth is now a wholly owned subsidiary of Pfizer

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 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
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