Uterine Leiomyomata (Fibroids)NCT00826436
Study Evaluating Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of PRA-027 in Japanese Postmenopausal Women
An observational study of Uterine Leiomyomata (Fibroids), run by Wyeth is now a wholly owned subsidiary of Pfizer at 1 site in Japan.
Trial summary
The primary purpose of this study is to assess the safety and tolerability of ascending, multiple, oral doses of PRA-027 in Japanese postmenopausal women. The secondary purpose is to evaluate the PK and PD profile of multiple oral doses of PRA-027 in Japanese postmenopausal women. Read more about this study
- Who is it for?
- Ages 35 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Uterine Leiomyomata (Fibroids)
- How many people
- 16 participants
- Where
- 1 siteJapan
- Study dates
- Nov 2008to Mar 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: community sample
Who may be able to join
- Aged 35 to 65 years inclusive on study day 1 of the treatment period. Menopause may be spontaneous or due to surgery.
- Postmenopausal women are defined as follows:
- Spontaneous amenorrhea must have begun by age 55 years.
- Spontaneous amenorrhea must have initiated at least 6 months before study day 1 of the treatment period.
- For subjects who have had spontaneous amenorrhea for at least 6 months but less than 12 months before screening, follicle-stimulating hormone (FSH) level must be ≥ 38 mIU/mL.
- For subjects who have had spontaneous amenorrhea for 12 months or longer before screening, no FSH level determination is required.
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- For subjects who have had amenorrhea as a result of bilateral oophorectomy without hysterectomy; surgery must have occurred at least 6 months before screening. No FSH measurement is required. Subjects must provide evidence of the procedure by an operative report or by ultrasound scan. The date (month/year) of the subjects' last menstrual period must be determined and recorded on the source document.
- Body mass index (BMI) in the range of 17.6 to 26.4 kg/m2 and bodyweight ≥ 45 kg.
- BMI is calculated by taking the subject's weight, in kilograms, divided by the square of the subject's average height, in meters, at screening:BMI = weight (kg)/[Height (m)]2
- Healthy, as determined by the investigator, on the basis of screening evaluations.
- Alanine aminotransferase (ALT), aspartate aminotransferase (AST), and creatinine levels should be below the upper limit of normal at screening.
- Nonsmoker or smoker of fewer than 10 cigarettes per day as determined by history. Must be able to abstain from smoking during the inpatient stay.
- Have a high probability for compliance with and completion of the study.
Who cannot join
- Presence or history of any disorder that may prevent the successful completion of the study.
- Any significant cardiovascular, hepatic, renal, respiratory,gynecologic, gastrointestinal, endocrine, immunologic,dermatologic, hematologic, neurologic, or psychiatric disease.
- Women with asymptomatic leiomyomata may be enrolled in the study.
- Women who have undergone a hysterectomy.
- Women with complex or simple ovarian cysts greater than 3 cm indiameter.
- Any surgical or medical condition that may interfere with the absorption, distribution, metabolism, or excretion of the test article (eg, resection of liver, kidney, gallbladder, or gastrointestinal tract).
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- Acute disease state (eg, nausea, vomiting, fever, or diarrhea) within 7 days before receiving test article (treatment period study day 1).
- History of drug abuse.
- Admitted alcohol abuse or history of alcohol use that may interfere with the subject's ability to comply with the protocol requirements.
- History or presence of polycystic ovarian disease.
- History of female infertility.
- History or family history of arterial or venous thrombosis.
- Any clinically significant deviation from normal limits in results of physical examinations, vital sign measurements, 12-lead electrocardiograms (ECGs), or clinical laboratory tests.
- Demonstration of positive findings on orthostatic testing at screening. The definition of a positive finding is a ≥20 mm Hg decrease in systolic blood pressure, a ≥ 10 mm Hg decrease in diastolic blood pressure, or a ≥ 30 bpm increase in pulse, after standing for 3 minutes.
- Positive serologic findings for human immunodeficiency virus (HIV) antibodies, hepatitis B surface antigen (HBsAg), and/or hepatitis C virus (HCV) antibodies.
- Positive findings from urine drug screening (eg, amphetamines,barbiturates, benzodiazepines, cannabinoids, cocaine, opiates and phencyclidine [PCP]).
- History of any clinically important drug allergy or adverse drug reaction (eg, relapsing dermatitis, drug hypersensitivity, drug allergy, hypersensitivity to ingredient in the test articles, angioedemas)
- Use of any investigational or prescription drug within 90 days before receiving test article (treatment period day 1)or prescription drug within 30 days before study day 1.
- Consumption of any caffeine-containing products (eg, coffee, tea, chocolate, or carbonated beverages) or alcoholic beverages within 48 hours before receiving test article (treatment period day 1).
- Consumption of grapefruit or grapefruit-containing products within 72 hours before study day 1 (treatment period day 1).
- Use of any over-the-counter drugs, including herbal supplements (except for the use of vitamins ≤ 100% of the recommended daily allowance), within 14 days before receiving test article (treatment period day 1).
- Donation of blood within 90 days before study day 1.
- Subjects deemed by the investigator to be inappropriate according for the inclusion in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Placebo-Controlled, Double-Blind, Multiple-Dose Study of the Safety, Tolerability, Pharmacokinetics (PK), and Pharmacodynamics (PD) of PRA-027 Administered Orally to Japanese Postmenopausal Women
The primary purpose of this study is to assess the safety and tolerability of ascending, multiple, oral doses of PRA-027 in Japanese postmenopausal women. The secondary purpose is to evaluate the PK and PD profile of multiple oral doses of PRA-027 in Japanese postmenopausal women.
- Conditions
- Uterine Leiomyomata (Fibroids)
- Medical subject headings
- Myofibroma, Leiomyoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 8 subjects for Cohort 1 | Not described | |
| 8 subjects for Cohort 2 | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the safety and tolerability of multiple oral doses of PRA-027 in postmenopausal women.
Measured: 28 days
Secondary outcomes (1)
To evaluate the Pharmacokinetics and Pharmacodynamics profile of multiple oral doses of PRA-027 in postmenopausal women.
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2009 (estimated)
- Study startNov 2008
- Primary completionMar 2009
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uterine Leiomyomata (Fibroids)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Medical Monitor, Study director, Wyeth is now a wholly owned subsidiary of Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00826436
- Sponsor's protocol ID
- 3208A1-1008
- Status last verified
- Mar 2009
- First submitted
- 20 Jan 2009
- Last updated
- 6 Mar 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Placebo-Controlled, Double-Blind, Multiple-Dose Study of the Safety, Tolerability, Pharmacokinetics (PK), and Pharmacodynamics (PD) of PRA-027 Administered Orally to Japanese Postmenopausal Women
- ClinicalTrials.gov ID
- NCT00826436
- Acronym / sponsor ID
- 3208A1-1008
- Conditions
- Uterine Leiomyomata (Fibroids)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Wyeth is now a wholly owned subsidiary of PfizerIndustry (pharma, biotech, devices)
- Study start
- Nov 2008
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 22 Jan 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary purpose of this study is to assess the safety and tolerability of ascending, multiple, oral doses of PRA-027 in Japanese postmenopausal women. The secondary purpose is to evaluate the PK and PD profile of multiple oral doses of PRA-027 in Japanese postmenopausal women.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 8 subjects for Cohort 1 | – | – |
| 8 subjects for Cohort 2 | – | – |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- community sample
Key inclusion criteria (13 listed)
- Aged 35 to 65 years inclusive on study day 1 of the treatment period. Menopause may be spontaneous or due to surgery.
- Body mass index (BMI) in the range of 17.6 to 26.4 kg/m2 and bodyweight ≥ 45 kg.
- BMI is calculated by taking the subject's weight, in kilograms, divided by the square of the subject's average height, in meters, at screening:BMI = weight (kg)/[Height (m)]2
- Healthy, as determined by the investigator, on the basis of screening evaluations.
- Alanine aminotransferase (ALT), aspartate aminotransferase (AST), and creatinine levels should be below the upper limit of normal at screening.
Key exclusion criteria (23 listed)
- Presence or history of any disorder that may prevent the successful completion of the study.
- Any significant cardiovascular, hepatic, renal, respiratory,gynecologic, gastrointestinal, endocrine, immunologic,dermatologic, hematologic, neurologic, or psychiatric disease.
- Women who have undergone a hysterectomy.
- Women with complex or simple ovarian cysts greater than 3 cm indiameter.
- Any surgical or medical condition that may interfere with the absorption, distribution, metabolism, or excretion of the test article (eg, resection of liver, kidney, gallbladder, or gastrointestinal tract).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To assess the safety and tolerability of multiple oral doses of PRA-027 in postmenopausal women.
Time frame: 28 days
1 secondary outcome
To evaluate the Pharmacokinetics and Pharmacodynamics profile of multiple oral doses of PRA-027 in postmenopausal women.
Time frame: 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Monitor study director
Wyeth is now a wholly owned subsidiary of Pfizer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Uterine Leiomyomata (Fibroids), run by Wyeth is now a wholly owned subsidiary of Pfizer at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Mar 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess the safety and tolerability of multiple oral doses of PRA-027 in postmenopausal women. (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2009.