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Study Evaluating PRA-027 Multiple Ascending Doses In Cycling And Postmenopausal Women

This study has been completed.
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00543790
First received: October 11, 2007
Last updated: October 27, 2010
Last verified: October 2010

October 11, 2007
October 27, 2010
November 2007
December 2008   (final data collection date for primary outcome measure)
To assess the safety and tolerability of ascending, multiple, oral doses of PRA-027 in cycling and postmenopausal women. [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
To assess the safety and tolerability of ascending, multiple, oral doses of PRA-027 in cycling and postmenopausal women.
Complete list of historical versions of study NCT00543790 on ClinicalTrials.gov Archive Site
To provide the PK and PD profile of multiple oral doses of PRA-027 in cycling and postmenopausal women. [ Time Frame: 28 days ] [ Designated as safety issue: No ]
To provide the PK and PD profile of multiple oral doses of PRA-027 in cycling and postmenopausal women.
Not Provided
Not Provided
 
Study Evaluating PRA-027 Multiple Ascending Doses In Cycling And Postmenopausal Women
A Randomized, Placebo-Controlled, Double-Blind, Sponsor-Unblinded, Multiple-Dose Study Of The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Of PRA-027 Administered Orally To Cycling Or Postmenopausal Women

This is the first multiple-dose study in humans with PRA-027. This study will provide an assessment of the safety, tolerability, pharmacokinetics (how the drug is absorbed, metabolized and excreted by the body) and pharmacodynamics (a measure of whether the drug is active in the body) of PRA-027 after administration of 28 days of oral doses in women of childbearing potential (cycling) or postmenopausal women.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Uterine Leiomyomata (Fibroids)
Drug: PRA-027
PRA-027 capsules; cohort-specific doses or 40, 120, 240 or 500 mg; 1 dose daily for 28 days
Experimental: 1
Intervention: Drug: PRA-027
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
48
December 2008
December 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

Inclusion Criteria - All Women

  • Healthy, nonsmoker or smoker of fewer than 10 cigarettes (half a pack) per day and able to abstain from tobacco throughout all times when in the clinical facility.

Inclusion Criteria - Cycling Women

  • Aged 18 to 45 years, must not be breastfeeding, pregnant, or have a recent (within 90 days before pretreatment period day 1) history of pregnancy, with a history of regular menstrual cycles (21 to 35 days in duration).

Inclusion Criteria - Postmenopausal Women

  • Aged 35 to 65 years, menopause may be natural or due to surgery, natural amenorrhea must have begun by age of 55 years and have initiated at least 6 months before study day 1.

Exclusion Criteria:

  • Women with hysterectomy or complex or simple ovarian cysts greater than 3 cm in diameter.
  • History of drug abuse (within 6 months) or alcoholism (within 12 months).
  • History of female infertility.
Female
18 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00543790
3208A1-1001, B2531001
No
Director, Clinical Trial Disclosure Group, Pfizer, Inc
Wyeth is now a wholly owned subsidiary of Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Wyeth is now a wholly owned subsidiary of Pfizer
October 2010

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