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

Last updated on November 15, 2019

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Study Location
Pfizer Investigational Site
Beverly Hills, California, 90211 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Uterine Leiomyomata (Fibroids)
Sex
Female
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-65 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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

- 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.

NCT00543790
Pfizer
Completed
Study Evaluating PRA-027 Multiple Ascending Doses In Cycling And Postmenopausal Women

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Descriptive Information
Brief Title  ICMJE Study Evaluating PRA-027 Multiple Ascending Doses In Cycling And Postmenopausal Women
Official Title  ICMJE 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
Brief SummaryThis 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.
Detailed DescriptionNot Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Uterine Leiomyomata (Fibroids)
Intervention  ICMJE Drug: PRA-027
PRA-027 capsules; cohort-specific doses or 40, 120, 240 or 500 mg; 1 dose daily for 28 days
Study Arms  ICMJE Experimental: 1
Intervention: Drug: PRA-027
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: October 11, 2007)
48
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2008
Actual Primary Completion DateDecember 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:Female
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00543790
Other Study ID Numbers  ICMJE 3208A1-1001
B2531001
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyDirector, Clinical Trial Disclosure Group, Pfizer, Inc
Study Sponsor  ICMJE Wyeth is now a wholly owned subsidiary of Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountWyeth is now a wholly owned subsidiary of Pfizer
Verification DateOctober 2010

ICMJE     Data element required by the

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

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Contact a representative by phone, email, or visiting the study website. Please see the references below:

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