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Completed

NCT Number: NCT00800618

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

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

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Key information

Conditions

Endometriosis Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Urogenital Diseases

Age range

18 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Pfizer Investigational Site, Brussels, Belgium

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PF-02413873 100 mg QD

Drug

100 mg of PF-02413873 oral suspension once daily for 14 days

PF-02413873 1500 mg QD

Drug

1500 mg of PF-02413873 oral suspension once daily for 14 days

PF-02413873 20 mg QD

Drug

20 mg of PF-02413873 oral suspension once daily for 14 days

PF-02413873 500 mg QD

Drug

500 mg of PF-02413873 oral suspension once daily for 14 days

PF-02413873 Placebo

Drug

PF-0241383 Placebo once daily for 14 days

Primary outcomes

  1. Adverse events, vital signs measurements, 12-lead ECGs, physical examination findings, blood safety tests.

    Time frame: 1 month

  2. PF-02413873 pharmacokinetics

    Time frame: 1 month

  3. Endometrial thickness, Ovarian follicular estradiol secretion, Pre-ovulatory LH surge, Corpus Luteum progesterone secretion.

    Time frame: 14 days

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

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.

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Dec 2, 2008
Registry last updated
Feb 10, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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