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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

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NCT00800618

Last updated on December 16, 2017
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FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
New Haven, Connecticut, 06511 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.
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

NCT00800618
Pfizer
Completed
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

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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
Females
18+
Years
Multiple Sites
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
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.
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
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Endometriosis
  • 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
  • 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
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
42
June 2009
June 2009   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Female
18 Years to 35 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Belgium,   United States
 
 
NCT00800618
B0461002
No
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
February 2010

ICMJE     Data element required by the

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

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