HealthyPhase 1NCT01137708
CP-690,550 And Oral Contraception Drug-Drug Interaction Study
A Phase 1 study testing ethinyloestradiol (EE) and levonorgestrel (LN), CP-690,550 + ethinyloestradiol (EE) and levonorgestrel (LN) and CP-690,550 + ethinyloestradiol (EE) and levonorgestrel (LN), ethinyloestradiol (EE) and levonorgestrel (LN) in people with Healthy, run by Pfizer at 1 site in Belgium.
Trial summary
This study is designed to assess whether co-administration of CP-690,550 and oral contraceptives will effect the metabolism of the oral contraceptives in healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- ethinyloestradiol (EE) and levonorgestrel (LN), CP-690,550 + ethinyloestradiol (EE) and levonorgestrel (LN) and CP-690,550 + ethinyloestradiol (EE) and levonorgestrel (LN), ethinyloestradiol (EE) and levonorgestrel (LN)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteBelgium
- Study dates
- Jun 2010to Jul 2010
- 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 55 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy female subjects
- No evidence of active or latent or inadequately treated infection with Mycobacterium tuberculosis
Who cannot join
- Any medical reason which would contraindicate the administration of oral contraceptives
- Clinically significant infections within the past 3 months or history of febrile illness within 5 days
- Positive screening test for Hepatitis B surface antigen, anti Hepatitis C antibody, or human immunodeficiency virus
- Pregnant or nursing women, and women of childbearing potential who are unwilling or unable to use an acceptable method of nonhormonal contraception
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Randomized, Open Label, 2-Way Crossover Study To Assess The Effect Of Multiple Dose CP-690,550 On The Pharmacokinetics Of Single Dose Oral Contraceptive Steroids In Healthy Female Subjects
This study is designed to assess whether co-administration of CP-690,550 and oral contraceptives will effect the metabolism of the oral contraceptives in healthy volunteers.
- Conditions
- Healthy
- Being tested
- ethinyloestradiol (EE) and levonorgestrel (LN), CP-690,550 + ethinyloestradiol (EE) and levonorgestrel (LN), CP-690,550 + ethinyloestradiol (EE) and levonorgestrel (LN), ethinyloestradiol (EE) and levonorgestrel (LN)
- Keywords
- drug interactions, CYP3A, oral contraceptive, anti-rheumatic agents
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ethinyloestradiol (EE) and levonorgestrel (LN), CP-690,550 + ethinyloestradiol (EE) and levonorgestrel (LN)Drug
Period 1: 30 mcg ethinyloestradiol and 150 mcg levonorgestrel alone Period 2: 30 mcg ethinyloestradiol and 150 mcg levonorgestrel plus 30 mg CP-690,550 after 9 days of CP-690,550 at 30 mg BID
CP-690,550 + ethinyloestradiol (EE) and levonorgestrel (LN), ethinyloestradiol (EE) and levonorgestrel (LN)Drug
Period 1: 30 mcg ethinyloestradiol and 150 mcg levonorgestrel plus 30 mg CP-690,550 after 9 days of CP-690,550 at 30 mg BID Period 2: 30 mcg ethinyloestradiol and 150 mcg levonorgestrel alone
| Study group | Role | What they receive |
|---|---|---|
| Treatment Sequence 1 | Experimental | Not described Receives: Drug: ethinyloestradiol (EE) and levonorgestrel (LN), CP-690,550 + ethinyloestradiol (EE) and levonorgestrel (LN) |
| Treatment Sequence 2 | Experimental | Not described Receives: Drug: CP-690,550 + ethinyloestradiol (EE) and levonorgestrel (LN), ethinyloestradiol (EE) and levonorgestrel (LN) |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUCinf of ethinyloestradiol (EE) and levonorgestrel (LN)
Measured: 12 days
Secondary outcomes (4)
AUClast, Cmax, Tmax, and t½ of ethinyloestradiol (EE) and levonorgestrel (LN)
Measured: 12 days
Number of adverse events and number of participants with adverse events
Measured: 12 days
Changes in complete blood count and serum chemistry profile
Measured: 12 days
Changes in vital signs
Measured: 12 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2010 (estimated)
- Study startJun 2010
- Primary completionJul 2010
- Study completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 20 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
- NCT01137708
- Sponsor's protocol ID
- A3921071
- Status last verified
- Aug 2010
- First submitted
- 14 May 2010
- Last updated
- 6 Aug 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Open Label, 2-Way Crossover Study To Assess The Effect Of Multiple Dose CP-690,550 On The Pharmacokinetics Of Single Dose Oral Contraceptive Steroids In Healthy Female Subjects
- ClinicalTrials.gov ID
- NCT01137708
- Acronym / sponsor ID
- A3921071
- Conditions
- Healthy
- Keywords
- drug interactions, CYP3A, oral contraceptive, anti-rheumatic agents
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Jun 2010
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 4 Jun 2010 (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.
This study is designed to assess whether co-administration of CP-690,550 and oral contraceptives will effect the metabolism of the oral contraceptives in healthy volunteers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Sequence 1 | Experimental | Drug: ethinyloestradiol (EE) and levonorgestrel (LN), CP-690,550 + ethinyloestradiol (EE) and levonorgestrel (LN) |
| Treatment Sequence 2 | Experimental | Drug: CP-690,550 + ethinyloestradiol (EE) and levonorgestrel (LN), ethinyloestradiol (EE) and levonorgestrel (LN) |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy female subjects
- No evidence of active or latent or inadequately treated infection with Mycobacterium tuberculosis
Key exclusion criteria (4 listed)
- Any medical reason which would contraindicate the administration of oral contraceptives
- Clinically significant infections within the past 3 months or history of febrile illness within 5 days
- Positive screening test for Hepatitis B surface antigen, anti Hepatitis C antibody, or human immunodeficiency virus
- Pregnant or nursing women, and women of childbearing potential who are unwilling or unable to use an acceptable method of nonhormonal contraception
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 |
|---|---|---|
| ethinyloestradiol (EE) and levonorgestrel (LN), CP-690,550 + ethinyloestradiol (EE) and levonorgestrel (LN)Period 1: 30 mcg ethinyloestradiol and 150 mcg levonorgestrel alone Period 2: 30 mcg ethinyloestradiol and 150 mcg levonorgestrel plus 30 mg CP-690,550 after 9 days of CP-690,550 at 30 mg BID | Drug | Treatment Sequence 1 |
| CP-690,550 + ethinyloestradiol (EE) and levonorgestrel (LN), ethinyloestradiol (EE) and levonorgestrel (LN)Period 1: 30 mcg ethinyloestradiol and 150 mcg levonorgestrel plus 30 mg CP-690,550 after 9 days of CP-690,550 at 30 mg BID Period 2: 30 mcg ethinyloestradiol and 150 mcg levonorgestrel alone | Drug | Treatment Sequence 2 |
Primary outcome
AUCinf of ethinyloestradiol (EE) and levonorgestrel (LN)
Time frame: 12 days
4 secondary outcomes
AUClast, Cmax, Tmax, and t½ of ethinyloestradiol (EE) and levonorgestrel (LN)
Time frame: 12 days
Number of adverse events and number of participants with adverse events
Time frame: 12 days
Changes in complete blood count and serum chemistry profile
Time frame: 12 days
Changes in vital signs
Time frame: 12 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 Aug 2010.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ethinyloestradiol (EE) and levonorgestrel (LN), CP-690,550 + ethinyloestradiol (EE) and levonorgestrel (LN) and CP-690,550 + ethinyloestradiol (EE) and levonorgestrel (LN), ethinyloestradiol (EE) and levonorgestrel (LN) in people with Healthy, run by Pfizer at 1 site in Belgium.
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 2 inclusion and 4 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 Aug 2010. 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 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. 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?
AUCinf of ethinyloestradiol (EE) and levonorgestrel (LN) (time frame: 12 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 Aug 2010.