HealthyPhase 1/2NANOPAZNCT00689494
Cervical Device Contraception-2 (Nanopaz)
A Phase 1/2 study testing Nanopaz contraception device in people with Healthy, run by Bnai Zion Medical Center.
Trial summary
Measure blood progesterone by using cervical device contraception. Read more about this study
- Who is it for?
- Ages 1 month to 2 months, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Nanopaz contraception device
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- Jun 2008to May 2010
- Phase
- Phase 1/2
- 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 1 month to 2 months
- Women only
- Healthy volunteers accepted
- Child
Who may be able to join
- 10 healthy women are candidate for hysterectomy
Who cannot join
- Women with neoplastic malignancy disease or thrombophylia
About this study
Official title: Cervical Device Contraception
Measure blood progesterone by using cervical device contraception.
Read the detailed description
A very small cervical device that releases small amount of progesterone 20 mcgm/day.
The target of the research is to measure blood progesterone by using the cervical device.
This small device delivers progesterone by nanotechnology method.
- Conditions
- Healthy
- Being tested
- Nanopaz contraception device
- Keywords
- Nanopaz device, Blood progesterone measure in using the device, Delivery progesterone, Progesterone levonorgestrel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nanopaz contraception deviceOther
Also called levonorgestrel device for cervical contraception-nantechnolgy method
levonorgestrel and levonorgestrel device for cervical contraception-nantechnolgy method
What is being measured
The primary outcome is the main question the study is designed to answer.
blood progesterone measure in blood
Measured: one to two months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2008 (estimated)
- Study startJun 2008
- Primary completionDec 2008 (estimated)
- Study completionMay 2010 (estimated)
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.
- 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 1/2
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bnai Zion Medical Center
- Sponsor type
- Other government
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00689494
- Sponsor's protocol ID
- BnaiZionMC-08-BP-003-CTIL
- Acronym
- NANOPAZ
- Status last verified
- Jun 2008
- First submitted
- 19 May 2008
- Last updated
- 3 Jun 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cervical Device Contraception
- ClinicalTrials.gov ID
- NCT00689494
- Acronym / sponsor ID
- NANOPAZ / BnaiZionMC-08-BP-003-CTIL
- Conditions
- Healthy
- Keywords
- Nanopaz device, Blood progesterone measure in using the device, Delivery progesterone, Progesterone levonorgestrel
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Bnai Zion Medical CenterOther government
- Study start
- Jun 2008
- Primary completion
- Dec 2008 (estimated)
- Study completion
- May 2010 (estimated)
- First posted
- 3 Jun 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.
Measure blood progesterone by using cervical device contraception.
Detailed description
A very small cervical device that releases small amount of progesterone 20 mcgm/day.
The target of the research is to measure blood progesterone by using the cervical device.
This small device delivers progesterone by nanotechnology method.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 1 month to 2 months
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 10 healthy women are candidate for hysterectomy
Key exclusion criteria (1 listed)
- Women with neoplastic malignancy disease or thrombophylia
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 |
|---|---|---|
| Nanopaz contraception deviceAlso: levonorgestrel device for cervical contraception-nantechnolgy methodlevonorgestrel and levonorgestrel device for cervical contraception-nantechnolgy method | Other | – |
Primary outcome
blood progesterone measure in blood
Time frame: one to two months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2008.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Nanopaz contraception device in people with Healthy, run by Bnai Zion Medical Center.
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 1 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: status not confirmed, as of the sponsor's last update on 3 Jun 2008. Status can change between updates, so confirm with the study contact before making plans.
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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
blood progesterone measure in blood (time frame: one to two months). 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 3 Jun 2008.