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

Last updated on October 13, 2019

FOR MORE INFORMATION
Study Location
Huntsville, Alabama, 35801 United States
Contact
1-800-718-1021
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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Descriptive Information
Brief Title  ICMJE Study Evaluating Levonorgestrel/Ethinyl Estradiol (LNG/EE) in PMS
Official Title  ICMJE 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
Brief SummaryThe purpose of this study is to determine whether LNG/EE is effective in the treatment of menstrual cycle related symptoms.
Detailed DescriptionNot Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
Condition  ICMJE Premenstrual Syndrome
Intervention  ICMJE Drug: Levonorgestrel/Ethinyl Estradiol
Study Arms  ICMJE Not Provided
Publications *Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: September 7, 2005)
200
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2006
Actual Primary Completion DateAugust 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:Female
Ages  ICMJE 18 Years to 49 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00161681
Other Study ID Numbers  ICMJE 0858A2-322
B3121024 ( Other Identifier: Pfizer )
Has Data Monitoring CommitteeNot Provided
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyWyeth is now a wholly owned subsidiary of Pfizer
Study Sponsor  ICMJE Wyeth is now a wholly owned subsidiary of Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Medical Monitor, MDWyeth is now a wholly owned subsidiary of Pfizer
PRS AccountWyeth is now a wholly owned subsidiary of Pfizer
Verification DateMay 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 the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

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Contact

[email protected]

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