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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


Phase 1
18 Years
65 Years
Not Enrolling
Female
Uterine Leiomyomata (Fibroids)

Thank you

Trial Information

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


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

To assess the safety and tolerability of ascending, multiple, oral doses of PRA-027 in cycling and postmenopausal women.

Outcome Time Frame:

28 days

Safety Issue:

Yes

Principal Investigator

Pfizer CT.gov Call Center

Investigator Role:

Study Director

Investigator Affiliation:

Pfizer

Authority:

United States: Food and Drug Administration

Study ID:

3208A1-1001

NCT ID:

NCT00543790

Start Date:

November 2007

Completion Date:

December 2008

Related Keywords:

  • Uterine Leiomyomata (Fibroids)
  • Leiomyoma
  • Myofibroma

Name

Location

Pfizer Investigational SiteBlendora, California  91740
Pfizer Investigational SiteClearwater, Florida  33761