EndometriosisPhase 1NCT00800618
A Study To Investigate How The Body Handles Multiple Doses Of PF-0243873 And To Investigate The Effect Of PF-02413873 On Sex Hormone Levels In Healthy Young Women
A Phase 1 study testing PF-02413873 100 mg QD, PF-02413873 1500 mg QD and PF-02413873 20 mg QD in people with Endometriosis, run by Pfizer at 4 sites in 2 countries.
Trial summary
The study will investigate how well multiple doses of PF-02413873 are tolerated by healthy young women, how the body handles multiple doses of PF-02413873 and which effect PF-02413873 has on sex hormones in healthy young women Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Endometriosis
- What is being tested?
- PF-02413873 100 mg QD, PF-02413873 1500 mg QD and PF-02413873 20 mg QD
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 4 sitesin 2 countries
- Study dates
- Nov 2008to Jun 2009
- Phase
- Phase 1
- 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 18 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy women of childbearing potential with a regular menstrual cycle
Who cannot join
- Evidence or history of any major disease
- Pregnant or nursing women
- Requirement for chronic medication
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
United States3 sites
Pfizer Investigational Site
New Haven, Connecticut, 06511
Pfizer Investigational Site
Overland Park, Kansas, 66211
Pfizer Investigational Site
Overland Park, Kansas, 66212
About this study
Official title: A Double Blind (3rd Party Open), Randomised, Placebo Controlled, Dose Escalating, Parallel Group Study To Investigate The Safety, Toleration, Pharmacology And Pharmacokinetics, Of Multiple Doses Of PF-02413873 In Healthy Female Subjects.
The study will investigate how well multiple doses of PF-02413873 are tolerated by healthy young women, how the body handles multiple doses of PF-02413873 and which effect PF-02413873 has on sex hormones in healthy young women
- Conditions
- Endometriosis
- Being tested
- PF-02413873 100 mg QD, PF-02413873 1500 mg QD, PF-02413873 20 mg QD, PF-02413873 500 mg QD, PF-02413873 Placebo
- Medical subject headings
- Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PF-02413873 100 mg QDDrug
100 mg of PF-02413873 oral suspension once daily for 14 days
PF-02413873 1500 mg QDDrug
1500 mg of PF-02413873 oral suspension once daily for 14 days
PF-02413873 20 mg QDDrug
20 mg of PF-02413873 oral suspension once daily for 14 days
PF-02413873 500 mg QDDrug
500 mg of PF-02413873 oral suspension once daily for 14 days
PF-02413873 PlaceboDrug
PF-0241383 Placebo once daily for 14 days
| Study group | Role | What they receive |
|---|---|---|
| PF-02413873 | Experimental | PF-2413873 active treatment Receives: Drug: PF-02413873 100 mg QD; Drug: PF-02413873 1500 mg QD; Drug: PF-02413873 20 mg QD; Drug: PF-02413873 500 mg QD |
| Placebo | Placebo comparator | Placebo Receives: Drug: PF-02413873 Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events, vital signs measurements, 12-lead ECGs, physical examination findings, blood safety tests.
Measured: 1 month
PF-02413873 pharmacokinetics
Measured: 1 month
Endometrial thickness, Ovarian follicular estradiol secretion, Pre-ovulatory LH surge, Corpus Luteum progesterone secretion.
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2008 (estimated)
- Study startNov 2008
- Primary completionJun 2009
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EndometriosisStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00800618
- Sponsor's protocol ID
- B0461002
- Status last verified
- Feb 2010
- First submitted
- 1 Dec 2008
- Last updated
- 10 Feb 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double Blind (3rd Party Open), Randomised, Placebo Controlled, Dose Escalating, Parallel Group Study To Investigate The Safety, Toleration, Pharmacology And Pharmacokinetics, Of Multiple Doses Of PF-02413873 In Healthy Female Subjects.
- ClinicalTrials.gov ID
- NCT00800618
- Acronym / sponsor ID
- B0461002
- Conditions
- Endometriosis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Nov 2008
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 2 Dec 2008 (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 study will investigate how well multiple doses of PF-02413873 are tolerated by healthy young women, how the body handles multiple doses of PF-02413873 and which effect PF-02413873 has on sex hormones in healthy young women
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PF-02413873 | Experimental | Drug: PF-02413873 100 mg QD, Drug: PF-02413873 1500 mg QD, Drug: PF-02413873 20 mg QD, Drug: PF-02413873 500 mg QDPF-2413873 active treatment |
| Placebo | Placebo comparator | Drug: PF-02413873 PlaceboPlacebo |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy women of childbearing potential with a regular menstrual cycle
Key exclusion criteria (3 listed)
- Evidence or history of any major disease
- Pregnant or nursing women
- Requirement for chronic medication
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PF-02413873 100 mg QD100 mg of PF-02413873 oral suspension once daily for 14 days | Drug | PF-02413873 |
| PF-02413873 1500 mg QD1500 mg of PF-02413873 oral suspension once daily for 14 days | Drug | PF-02413873 |
| PF-02413873 20 mg QD20 mg of PF-02413873 oral suspension once daily for 14 days | Drug | PF-02413873 |
| PF-02413873 500 mg QD500 mg of PF-02413873 oral suspension once daily for 14 days | Drug | PF-02413873 |
| PF-02413873 PlaceboPF-0241383 Placebo once daily for 14 days | Drug | Placebo |
Primary outcome
Adverse events, vital signs measurements, 12-lead ECGs, physical examination findings, blood safety tests.
Time frame: 1 month
PF-02413873 pharmacokinetics
Time frame: 1 month
Endometrial thickness, Ovarian follicular estradiol secretion, Pre-ovulatory LH surge, Corpus Luteum progesterone secretion.
Time frame: 14 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 10 Feb 2010.
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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.
Pfizer CT.gov Call Center study director
Pfizer
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PF-02413873 100 mg QD, PF-02413873 1500 mg QD and PF-02413873 20 mg QD in people with Endometriosis, run by Pfizer at 4 sites in 2 countries.
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 1 inclusion and 3 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 10 Feb 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States, Belgium. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Adverse events, vital signs measurements, 12-lead ECGs, physical examination findings, blood safety tests. (time frame: 1 month). The study lists 3 primary outcomes in all. 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 10 Feb 2010.