PharmacokineticsPhase 1NCT00901290
Determine the Effects of C-administration of AZD7325 and an Oral Contraceptive in Healthy Female Subjects
A Phase 1 study testing monophasic oral contraceptive and AZD7325 in people with Pharmacokinetics, run by AstraZeneca at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the effect of repeated doses of AZD7325 on the pharmacokinetics of ORTHO-CYCLEN, a monophasic oral contraceptive Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pharmacokinetics
- What is being tested?
- monophasic oral contraceptive and AZD7325
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- May 2009to Sep 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 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- If previously pregnant, must be > 6 month post-partum at the time of randomization
- Body Mass Index (BMI) greater than or equal to 18 and less than or equal to 30 kg/m2
Who cannot join
- Use of any prescription medication within 14 days of screening
- current smoker or history of smoking within the last 3 months prior to enrollment
- Abnormal pap smear exam result within one year of enrollment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Open-Label, Two-way Crossover Study to Determine the Effects of Co-administration of AZD7325 and a Monophasic Oral Contraceptive Containing Ethinyl Estradiol and Norgestimate in Healthy Female Subjects
The purpose of this study is to evaluate the effect of repeated doses of AZD7325 on the pharmacokinetics of ORTHO-CYCLEN, a monophasic oral contraceptive
- Conditions
- Pharmacokinetics
- Being tested
- monophasic oral contraceptive, AZD7325
- Keywords
- oral contraceptive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
monophasic oral contraceptiveDrug
Also called ORTHO-CYCLEN
mg, oral dose
AZD7325Drug
mg, oral dose
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | monophasic oral contraceptive Receives: Drug: monophasic oral contraceptive |
| 2 | Experimental | AZD7325 Receives: Drug: AZD7325 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the effect of repeated doses of AZD7325 on the pharmacokinetics of ORTHO-CYCLEN
Measured: weekly
Secondary outcomes (3)
Characterize the pharmacokinetics of progesterone, luteinizing hormone, follicle-stimulating hormone, and sex hormone binding globulin following dosing with monophasic oral contraceptive (ORTH-CYCLEN) alone and following co-administration with AZD7325
Measured: weekly
To characterize the steady-state pharmacokinetics of AZD7325
Measured: weekly
To examine the safety and tolerability of AZD7325 in combination with the monophasic oral contraceptive (ORTHO-CYCLEN)
Measured: weekly
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2009 (estimated)
- Study startMay 2009
- Primary completionSep 2009 (estimated)
- Study completionSep 2009 (estimated)
Why it stopped: suspended pending data analysis
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PharmacokineticsStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe 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
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Eleanor Lisbon, MD, MPH, Principal investigator, Quintiles Phase I Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00901290
- Sponsor's protocol ID
- D1140C00018
- Status last verified
- Oct 2009
- First submitted
- 12 May 2009
- Last updated
- 10 Dec 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-Label, Two-way Crossover Study to Determine the Effects of Co-administration of AZD7325 and a Monophasic Oral Contraceptive Containing Ethinyl Estradiol and Norgestimate in Healthy Female Subjects
- ClinicalTrials.gov ID
- NCT00901290
- Acronym / sponsor ID
- D1140C00018
- Conditions
- Pharmacokinetics
- Keywords
- oral contraceptive
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: suspended pending data analysis
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- May 2009
- Primary completion
- Sep 2009 (estimated)
- Study completion
- Sep 2009 (estimated)
- First posted
- 13 May 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 purpose of this study is to evaluate the effect of repeated doses of AZD7325 on the pharmacokinetics of ORTHO-CYCLEN, a monophasic oral contraceptive
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: monophasic oral contraceptivemonophasic oral contraceptive |
| 2 | Experimental | Drug: AZD7325AZD7325 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- If previously pregnant, must be > 6 month post-partum at the time of randomization
- Body Mass Index (BMI) greater than or equal to 18 and less than or equal to 30 kg/m2
Key exclusion criteria (3 listed)
- Use of any prescription medication within 14 days of screening
- current smoker or history of smoking within the last 3 months prior to enrollment
- Abnormal pap smear exam result within one year of enrollment.
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 |
|---|---|---|
| monophasic oral contraceptiveAlso: ORTHO-CYCLENmg, oral dose | Drug | 1 |
| AZD7325mg, oral dose | Drug | 2 |
Primary outcome
To evaluate the effect of repeated doses of AZD7325 on the pharmacokinetics of ORTHO-CYCLEN
Time frame: weekly
3 secondary outcomes
Characterize the pharmacokinetics of progesterone, luteinizing hormone, follicle-stimulating hormone, and sex hormone binding globulin following dosing with monophasic oral contraceptive (ORTH-CYCLEN) alone and following co-administration with AZD7325
Time frame: weekly
To characterize the steady-state pharmacokinetics of AZD7325
Time frame: weekly
To examine the safety and tolerability of AZD7325 in combination with the monophasic oral contraceptive (ORTHO-CYCLEN)
Time frame: weekly
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 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.
Eleanor Lisbon, MD, MPH principal investigator
Quintiles Phase I Services
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 monophasic oral contraceptive and AZD7325 in people with Pharmacokinetics, run by AstraZeneca at 1 site in United States.
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 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: paused, as of the sponsor's last update on 10 Dec 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 United States. 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?
Results are not available in the source record.
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 evaluate the effect of repeated doses of AZD7325 on the pharmacokinetics of ORTHO-CYCLEN (time frame: weekly). 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 Dec 2010.