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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00543790
Recruitment Status : Completed
First Posted : October 15, 2007
Last Update Posted : October 28, 2010
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Uterine Leiomyomata (Fibroids) Drug: PRA-027 Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : November 2007
Actual Primary Completion Date : December 2008
Actual Study Completion Date : December 2008

Arm Intervention/treatment
Experimental: 1 Drug: PRA-027
PRA-027 capsules; cohort-specific doses or 40, 120, 240 or 500 mg; 1 dose daily for 28 days

Primary Outcome Measures :
  1. To assess the safety and tolerability of ascending, multiple, oral doses of PRA-027 in cycling and postmenopausal women. [ Time Frame: 28 days ]

Secondary Outcome Measures :
  1. To provide the PK and PD profile of multiple oral doses of PRA-027 in cycling and postmenopausal women. [ Time Frame: 28 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00543790

United States, California
Pfizer Investigational Site
Beverly Hills, California, United States, 90211
United States, Florida
Pfizer Investigational Site
Miami, Florida, United States, 33126
Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Study Director: Pfizer Call Center Pfizer

Additional Information:
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc Identifier: NCT00543790     History of Changes
Other Study ID Numbers: 3208A1-1001
First Posted: October 15, 2007    Key Record Dates
Last Update Posted: October 28, 2010
Last Verified: October 2010

Additional relevant MeSH terms:
Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms, Connective Tissue
Connective Tissue Diseases