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
18 Years
65 Years
Not Enrolling
Female
Uterine Leiomyomata (Fibroids)
Female
Uterine Leiomyomata (Fibroids)
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 Site | Blendora, California 91740 |
| Pfizer Investigational Site | Clearwater, Florida 33761 |
