A Study To Investigate How The Body Handles Multiple Doses Of PF-0243873 And To Investigate The Effect Of PF-02413873 On Sex Hormone Levels In Healthy Young Women

NCT00800618

Last updated date
Study Location
Pfizer Investigational Site
New Haven, Connecticut, 06511, United States
Contact
1-800-718-1021

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

By email

Contact

[email protected]

Call Now

Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Endometriosis
Sex
Female
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-35 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Healthy women of childbearing potential with a regular menstrual cycle

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


- Evidence or history of any major disease


- Pregnant or nursing women


- Requirement for chronic medication

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

TRY A NEW SEARCH

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.

Based on your search, you may also be interested in

EndometriosisA Study To Investigate How The Body Handles Multiple Doses Of PF-0243873 And To Investigate The Effect Of PF-02413873 On Sex Hormone Levels In Healthy Young Women NCT00800618
  1. New Haven, Connecticut
  2. Overland Park, Kansas
  3. Overland Park, Kansas
  4. Bruxelles,
Female
18 Years+
years
MULTIPLE SITES
EndometriosisA Clinical Study To Investigate The Effectiveness And Safety Of Tanezumab In Treating Pain Associated With Endometriosis NCT00784693
  1. Mobile, Alabama
  2. Mobile, Alabama
  3. Mobile, Alabama
  4. Tucson, Arizona
  5. San Diego, California
  6. San Diego, California
  7. Boynton Beach, Florida
  8. Crystal River, Florida
  9. Jacksonville, Florida
  10. West Palm Beach, Florida
  11. West Palm Beach, Florida
  12. Atlanta, Georgia
  13. Overland Park, Kansas
  14. Overland Park, Kansas
  15. Fall River, Massachusetts
  16. Paw Paw, Michigan
  17. Lincoln, Nebraska
  18. Kernersville, North Carolina
  19. Winston-Salem, North Carolina
  20. Columbus, Ohio
  21. Tulsa, Oklahoma
  22. Altoona, Pennsylvania
  23. Greenville, South Carolina
  24. Chattanooga, Tennessee
  25. East Ridge, Tennessee
  26. Houston, Texas
  27. Houston, Texas
  28. Salt Lake City, Utah
  29. Salt Lake City, Utah
  30. Seattle, Washington
Female
18 Years+
years
MULTIPLE SITES
EndometriosisStudy Evaluating ERB-041 in Endometriosis in Reproductive-Age Women NCT00110487
  1. Phoenix, Arizona
  2. Tucson, Arizona
  3. Carmichael, California
  4. La Jolla, California
  5. Redding, California
  6. San Diego, California
  7. Lakewood, Colorado
  8. Aventura, Florida
  9. Boynton, Florida
  10. Celebration, Florida
  11. Clearwater, Florida
  12. Miami, Florida
  13. Miami, Florida
  14. New Port Richey, Florida
  15. Ocala, Florida
  16. Palm Harbor, Florida
  17. Alpharetta, Georgia
  18. Atlanta, Georgia
  19. Arlington Heights, Illinois
  20. Champaign, Illinois
  21. Chicago, Illinois
  22. Chicago, Illinois
  23. Oak Brook, Illinois
  24. South Bend, Indiana
  25. Shreveport, Louisiana
  26. Lanham, Maryland
  27. Laurel, Maryland
  28. Detroit, Michigan
  29. Chaska, Minnesota
  30. Chesterfield, Missouri
  31. Las Vegas, Nevada
  32. Berlin, New Jersey
  33. Charlotte, North Carolina
  34. Fargo, North Dakota
  35. Cincinnati, Ohio
  36. Cleveland, Ohio
  37. Eugene, Oregon
  38. Greenville, South Carolina
  39. Greer, South Carolina
  40. Dallas, Texas
  41. Fort Worth, Texas
  42. Webster, Texas
  43. Sandy, Utah
  44. Norfolk, Virginia
  45. Richmond, Virginia
  46. Madison, Wisconsin
Female
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE A Study To Investigate How The Body Handles Multiple Doses Of PF-0243873 And To Investigate The Effect Of PF-02413873 On Sex Hormone Levels In Healthy Young Women
Official Title  ICMJE A Double Blind (3rd Party Open), Randomised, Placebo Controlled, Dose Escalating, Parallel Group Study To Investigate The Safety, Toleration, Pharmacology And Pharmacokinetics, Of Multiple Doses Of PF-02413873 In Healthy Female Subjects.
Brief Summary The study will investigate how well multiple doses of PF-02413873 are tolerated by healthy young women, how the body handles multiple doses of PF-02413873 and which effect PF-02413873 has on sex hormones in healthy young women
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Condition  ICMJE Endometriosis
Intervention  ICMJE
  • Drug: PF-02413873 100 mg QD
    100 mg of PF-02413873 oral suspension once daily for 14 days
  • Drug: PF-02413873 1500 mg QD
    1500 mg of PF-02413873 oral suspension once daily for 14 days
  • Drug: PF-02413873 20 mg QD
    20 mg of PF-02413873 oral suspension once daily for 14 days
  • Drug: PF-02413873 500 mg QD
    500 mg of PF-02413873 oral suspension once daily for 14 days
  • Drug: PF-02413873 Placebo
    PF-0241383 Placebo once daily for 14 days
Study Arms  ICMJE
  • Experimental: PF-02413873
    PF-2413873 active treatment
    Interventions:
    • Drug: PF-02413873 100 mg QD
    • Drug: PF-02413873 1500 mg QD
    • Drug: PF-02413873 20 mg QD
    • Drug: PF-02413873 500 mg QD
  • Placebo Comparator: Placebo
    Placebo
    Intervention: Drug: PF-02413873 Placebo
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
Actual Enrollment  ICMJE
 (submitted: February 9, 2010)
42
Original Estimated Enrollment  ICMJE
 (submitted: December 1, 2008)
40
Actual Study Completion Date  ICMJE June 2009
Actual Primary Completion Date June 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy women of childbearing potential with a regular menstrual cycle

Exclusion Criteria:

  • Evidence or history of any major disease
  • Pregnant or nursing women
  • Requirement for chronic medication
Sex/Gender  ICMJE
Sexes Eligible for Study:Female
Ages  ICMJE 18 Years to 35 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00800618
Other Study ID Numbers  ICMJE B0461002
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date February 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP