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

Last updated on March 14, 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.
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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.
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- 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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