HealthyPhase 1NCT00685906
AZD6140 Oral Contraceptive Interaction Study
A Phase 1 study testing AZD6140 and Levonorgestrel and Ethinyl Estradiol (Nordette®) in people with Healthy, run by AstraZeneca at 1 site in United States.
Trial summary
The purpose of this study is to examine the effect of co-administration of AZD6140 and Nordette® on the blood levels of certain female hormones. 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
- Healthy
- What is being tested?
- AZD6140 and Levonorgestrel and Ethinyl Estradiol (Nordette®)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2008to Oct 2008
- 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
- Females who are healthy, non-pregnant, not planning pregnancy within the study period, non-breast-feeding, and pre-menopausal
- Either currently taking Nordette® which was well tolerated for at least two months prior to randomisation with no history of break-through bleeding, or, willing to take Nordette for 2 months prior to receiving the study drug
- Females of child-bearing potential must be willing to use at least 1 additional medically approved non-hormonal barrier contraceptive method (for example, condom or diaphragm) that contains spermicide
Who cannot join
- History of intolerance (e.g. adverse events) to any oral contraceptive or AZD6140
- History of blood vessel or bleeding conditions that would make the volunteer more prone to bleeding
- History or presence of significant medical problems
- Women who are current smokers
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised, Double-blind, Two-way Crossover Study to Determine the Effects of Co-administration of AZD6140 and Nordette® (Combination of Levonorgestrel and Ethinyl Estradiol) After Multiple Oral Doses in Healthy Female Volunteers
The purpose of this study is to examine the effect of co-administration of AZD6140 and Nordette® on the blood levels of certain female hormones.
- Conditions
- Healthy
- Being tested
- AZD6140, Levonorgestrel and Ethinyl Estradiol (Nordette®)
- Keywords
- oral contraceptive, birth control, Healthy volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD6140Drug
90 mg tablet taken by mouth 2 times a day for 21 days per cycle
Levonorgestrel and Ethinyl Estradiol (Nordette®)Drug
Also called Nordette®
1 tablet taken by mouth once a day for 28 days per cycle
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: AZD6140 |
| 2 | Active comparator | Not described Receives: Drug: Levonorgestrel and Ethinyl Estradiol (Nordette®) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood levels of ethinyl estradiol, a female hormone, following oral administration of AZD6140 and Nordette®
Measured: At scheduled times following dosing during the first 3 weeks of menstrual cycles 1 and 2.
Secondary outcomes (3)
Blood levels of various other hormones following concomitant oral administration of AZD6140 and Nordette®
Measured: At scheduled times following dosing during the first 3 weeks of menstrual cycles 1 and 2.
Blood levels of AZD6140 and its main metabolite after concomitant oral administration of AZD6140 and Nordette®
Measured: At scheduled times following dosing during the first 3 weeks of Cycles 1 and 2.
Safety and tolerability of AZD6140 when co-administered with Nordette®
Measured: Screening through completion of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2008 (estimated)
- Study startApr 2008
- Primary completionOct 2008
- Study completionOct 2008
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 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
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Kathleen Butler, MD, Study director, AstraZenecaAudrey, Martinez, MD, Principal investigator, SeaView Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00685906
- Sponsor's protocol ID
- D5130C00042
- Other IDs
- AZD6140/OC Study
- Status last verified
- Dec 2010
- First submitted
- 27 May 2008
- Last updated
- 2 Dec 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Double-blind, Two-way Crossover Study to Determine the Effects of Co-administration of AZD6140 and Nordette® (Combination of Levonorgestrel and Ethinyl Estradiol) After Multiple Oral Doses in Healthy Female Volunteers
- ClinicalTrials.gov ID
- NCT00685906
- Acronym / sponsor ID
- D5130C00042
- Conditions
- Healthy
- Keywords
- oral contraceptive, birth control, Healthy volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Apr 2008
- Primary completion
- Oct 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 29 May 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 purpose of this study is to examine the effect of co-administration of AZD6140 and Nordette® on the blood levels of certain female hormones.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: AZD6140 |
| 2 | Active comparator | Drug: Levonorgestrel and Ethinyl Estradiol (Nordette®) |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Females who are healthy, non-pregnant, not planning pregnancy within the study period, non-breast-feeding, and pre-menopausal
- Either currently taking Nordette® which was well tolerated for at least two months prior to randomisation with no history of break-through bleeding, or, willing to take Nordette for 2 months prior to receiving the study drug
- Females of child-bearing potential must be willing to use at least 1 additional medically approved non-hormonal barrier contraceptive method (for example, condom or diaphragm) that contains spermicide
Key exclusion criteria (4 listed)
- History of intolerance (e.g. adverse events) to any oral contraceptive or AZD6140
- History of blood vessel or bleeding conditions that would make the volunteer more prone to bleeding
- History or presence of significant medical problems
- Women who are current smokers
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 |
|---|---|---|
| AZD614090 mg tablet taken by mouth 2 times a day for 21 days per cycle | Drug | 1 |
| Levonorgestrel and Ethinyl Estradiol (Nordette®)Also: Nordette®1 tablet taken by mouth once a day for 28 days per cycle | Drug | 2 |
Primary outcome
Blood levels of ethinyl estradiol, a female hormone, following oral administration of AZD6140 and Nordette®
Time frame: At scheduled times following dosing during the first 3 weeks of menstrual cycles 1 and 2.
3 secondary outcomes
Blood levels of various other hormones following concomitant oral administration of AZD6140 and Nordette®
Time frame: At scheduled times following dosing during the first 3 weeks of menstrual cycles 1 and 2.
Blood levels of AZD6140 and its main metabolite after concomitant oral administration of AZD6140 and Nordette®
Time frame: At scheduled times following dosing during the first 3 weeks of Cycles 1 and 2.
Safety and tolerability of AZD6140 when co-administered with Nordette®
Time frame: Screening through completion of the study
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 2 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.
Kathleen Butler, MD study director
AstraZeneca
Audrey, Martinez, MD principal investigator
SeaView Research
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 AZD6140 and Levonorgestrel and Ethinyl Estradiol (Nordette®) in people with Healthy, 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 3 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 2 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?
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?
Blood levels of ethinyl estradiol, a female hormone, following oral administration of AZD6140 and Nordette® (time frame: At scheduled times following dosing during the first 3 weeks of menstrual cycles 1 and 2.). 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 2 Dec 2010.