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

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NCT00161681

Last updated on May 12, 2018
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FOR MORE INFORMATION
Study Location
Huntsville, Alabama, 35801 United States
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Premenstrual Syndrome
Sex
Female
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-49 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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.

NCT00161681
Pfizer
Completed
Study Evaluating Levonorgestrel/Ethinyl Estradiol (LNG/EE) in PMS

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[email protected]

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Study Evaluating Levonorgestrel/Ethinyl Estradiol (LNG/EE) in PMS
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
The purpose of this study is to determine whether LNG/EE is effective in the treatment of menstrual cycle related symptoms.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
Premenstrual Syndrome
Drug: Levonorgestrel/Ethinyl Estradiol
Not Provided
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
200
August 2006
August 2006   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: Female
18 Years to 49 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00161681
0858A2-322
B3121024 ( Other Identifier: Pfizer )
Not Provided
Not Provided
Not Provided
Wyeth is now a wholly owned subsidiary of Pfizer
Wyeth is now a wholly owned subsidiary of Pfizer
Not Provided
Study Director: Medical Monitor, MD Wyeth is now a wholly owned subsidiary of Pfizer
Wyeth is now a wholly owned subsidiary of Pfizer
May 2007

ICMJE     Data element required by the

International Committee of Medical Journal Editors and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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[email protected]



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